title: A pivotal, international, randomised, double-blind, efficacy and safety trial of sodium valporate in paediatric and adult patients with Wolfram Syndrome

acronym: Treat Wolfram

lead_sponsor: University of Birmingham


title:
Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio)

 Essai multicentrique contrôlé randomisé en double aveugle contre placebo étudiant l’efficacité et la tolérance du védolizumab en prévention de la récidive postopératoire de maladie de Crohn après résection-anastomose iléo-colique (REPREVIO)

acronym:
REPREVIO

 REPREVIO

source: euctr

lead_sponsor: Academic Medical Center Amsterdam

study_type: Interventional

status: Ongoing

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A phase 2/3 prospective, multicentre randomized, double-blind trial, comparing intra-discal allogeneic adult BM-MSC therapy and sham-treated controls in subjects with chronic low back pain due to lumbar degenerative disc disease (DDD) unresponsive to conventional therapy

lead_sponsor: University Hospital of Montpellier

lead_sponsor_type: academique


title: COLCHICINE CORONAVIRUS SARS-CoV2 TRIAL

acronym: COLCORONA

lead_sponsor: Montreal Heart Institute Coordinating Centre

status: Prematurely Ended

status_simplified: Unknown


title: PHASE III, MULTI-CENTER, RANDOMIZED, 48 WEEKS, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CER-001 ON VESSEL WALL AREA IN PATIENTS WITH GENETICALLY DEFINED FAMILIAL PRIMARY HYPOALPHALIPOPROTEINEMIA AND RECEIVING BACKGROUND OPTIMIZED LIPID THERAPY

acronym: TANGO

lead_sponsor: CERENIS THERAPEUTICS SA


title: An Open-label, Single-dose, Safety and Pharmacokinetic Study of Regadenoson in Paediatric Patients

lead_sponsor: GE Healthcare Ltd.


title: A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) versus Pomalidomide plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (DREAMM 8)

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: BT8009-100:  Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies

lead_sponsor: BicycleTx Ltd.


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with a Tyrosine Kinase Inhibitor (TKI) in Patients with Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)

lead_sponsor: Kartos Therapeutics, Inc.


title:
A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment due to Alzheimer’s Disease or With Mild Alzheimer’s Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects with Asymptomatic Amyloid-Related Imaging Abnormalities

 Étude de phase 2 contrôlée, multicentrique, randomisée, en groupes parallèles et en double aveugle portant sur de l’aducanumab (BIIB037) chez des patients atteints de troubles cognitifs légers dus à la maladie d’Alzheimer ou de la maladie d’Alzheimer au stade léger, dont le but est d’évaluer la sécurité d’emploi lorsque l’on poursuit l’administration chez des patients présentant des anomalies d’imagerie  liées à l’amyloïde (ARIA) asymptomatiques

lead_sponsor: Biogen Idec Research Limited

status: Completed

status_simplified: Completed


title: A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) from Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects with Renal and/or Hepatic Impairment

lead_sponsor: Gilead Sciences, Inc.


title: A 3-part study to evaluate the efficacy and safety of venglustat in combination with Cerezyme in adult and pediatric patients with Gaucher disease Type 3 (GD3) with open-label long-term treatment

lead_sponsor: Genzyme Corporation


title: A Randomised, Double-Blind, Single dose, One-Day Early Administration, Multicentre Study comparing the Efficacy and Safety of Acyclovir Lauriad 50 mg muco-adhesive buccal tablet to matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients

acronym: LIP

lead_sponsor: Bioalliance Pharma


title: Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients with Chronic Low Back Pain

acronym: HMEN

lead_sponsor: Eli Lilly and Company Ltd.


title: An Eight-Week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, with Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients with Major Depressive Disorder

acronym: INDIGO

lead_sponsor: sanofi-aventis recherche & développement


title: A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of rhBMP-2/CPM as an Adjuvant Therapy in Closed Fractures of the Humerus

lead_sponsor: Wyeth Pharmaceuticals Inc.


title: An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals, Inc. Clinical Research and Development


title: A Phase II Study Of Oral LBH589 In Adult Patients With Multiple Myeloma Who Have Received At Least Two Prior Lines Of Therapy And Whose Disease Is Refractory To The Most Recent Line Of Therapy

lead_sponsor: Novartis Pharma Services AG


title: Efficacy and Safety of Hydrochlorothiazide Used as Add-on Therapy in Moderately to Severely Hypertensive Patients not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy

lead_sponsor: DAIICHI SANKYO EUROPE GmbH


title: A Phase I/II Clinical Trial of PXD101 in Combination with Idarubicin in Patients with AML Not Suitable for Standard Intensive Therapy

lead_sponsor: TopoTarget A/S


title: A Phase II multi-centre, extension study to investigate the long term safety of ONO-2506PO in patients diagnosed with Amyotrophic Lateral Sclerosis (ALS).

lead_sponsor: ONO Pharmaceutical Co., Ltd.


title: A randomized, observer blind, multinational phase III study to evaluate the safety and efficacy of a nanoemulsion gel formulation BF-200 ALA, in comparison with Metvix® and placebo, for the treatment of actinic keratosis with photodynamic therapy

lead_sponsor: Biofrontera Bioscience GmbH


title: A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with Rheumatoid Arthritis Having an Inadequate Response to Methotrexate. Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007); Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients with Subjective Tinnitus

lead_sponsor: Merz Pharmaceuticals GmbH


title: A PHASE 2, 12 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF PD 0299685 FOR THE TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME.

lead_sponsor: Pfizer Ltd;Ramsgate Road,Sandwich,Kent CT13 9NJ


title:
A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in Subjects with Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination with Metformin
 + Pharmacogenetics Blood Sample Protocol Amendment 1 (v1.0, Date 13-Aug-2008)

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase 2, Randomized, Open-Label Study to Evaluate ECG 	Results and Pharmacokinetic Parameters for Fludarabine, Cyclophosphamide, and Rituximab (FCR) in Combination with Lumiliximab Versus FCR Alone in Subjects with Previously Untreated Chronic Lymphocytic Leukemia.

lead_sponsor: Biogen Idec Ltd


title: A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as first Line Therapy for Locally Recurrent or Metastatic Breast Cancer.


title: A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF TWO LENALIDOMIDE DOSE REGIMENS IN SUBJECTS WITH RELAPSED OR REFRACTORY B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA

lead_sponsor: Celgene Corporation


title:
Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection.
 Revised Protocol 01, incorporating Amendment 02 (Version 1.0 Date 20-Nov-2006).


title:
A Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir Plus Tenofovir Combination Therapy vs Entecavir Monotherapy in Adults who are Treatment-Naïve to Nucleosides and Nucleotides: The BE-LOW Study.
 Revised Protocol 01, incorporating protocol amendment 02 (Version 2.0, Date 22-Jan-07).

acronym: The BE-LOW Study


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT-WITHDRAWAL STUDY OF THE EFFICACY AND SAFETY OF PANTOPRAZOLE SODIUM ENTERIC-COATED GRANULES IN INFANTS (1 THROUGH 11 MONTHS) WITH SYMPTOMATIC GERD.

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development


title: Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-), HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers

lead_sponsor: Pharma Mar, S.A.


title: Efficacy and safety of 2 mg/day M100907 on Sleep Maintenance Insomnia: a 6-week, multicenter, randomized, double-blind, placebo-controlled Polysomnographic study

acronym: Nocturne 907 (NPSG study of M100907)


title: Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia

acronym: PERTAIN

lead_sponsor: Janssen-Cilag International NV, Turnhoutsweg 30, 2340 BEERSE, Belgium


title: The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis

acronym: Not applicable

lead_sponsor: FoldRx Pharmaceuticals, Inc.


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients with Moderate to Severe Chronic Kidney Disease

lead_sponsor: Kureha Corporation


title: An Open-label (OL) Extension Study evaluating the Long-Term Safety of OxabactTM in Subjects with Primary Hyperoxaluria (PH) who participated in the Double-Blind (DB) Efficacy Study

acronym: Open label extension study to verify long term safety of OxabactTM , the Phoenix II study

lead_sponsor: OxThera, Inc.


title: A Phase III open-label titration trial to evaluate the effectiveness and safety of different doses of a dermal application of Testosterone MD-Lotion® (cutaneous solution) in hypogonadal men

lead_sponsor: Acrux Pharma Pty Ltd


title: A randomized, double-blind, placebo controlled, multi-centre phase IIb dose finding study to assess the effect on GERD symptoms, safety and tolerability during four weeks treatment with AZD3355 in doses 60 mg, 120 mg, 180 mg and 240 mg bid as add-on treatment to a PPI in patients with GERD that are partial responders to PPI treatment

lead_sponsor: AstraZeneca AB


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Refractory Heel Enthesitis in Spondylarthropathy

lead_sponsor: Wyeth Pharmaceuticals France


title: A double-blind, randomised study comparing the safety and tolerance of SMOFlipid 20% and Intralipid 20% in long-term treatment with parenteral nutrition

lead_sponsor: Fresenius Kabi Deutschland GmbH


title: A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

lead_sponsor: Astellas Pharma US, Inc.


title: An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy


title: A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 2 or 3 hepatitis C infection

lead_sponsor: Tibotec BVBA


title:
A Randomized, Double-Blind, Parallel, Three Arm, Multicenter, Phase II Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination with Taxol®/Paraplatin® (Paclitaxel/Carboplatin) Compared to Taxol®/Paraplatin® Alone in Previously Untreated Subjects with Lung Cancer
 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific, version 2.0 dated 20-Jul-07


title:
A Randomized, Multi-Dose, Open-Label, Phase II Study of BMS-663513 as a Second-Line Monotherapy in Subjects with Previously Treated Unresectable Stage III or Stage IV Melanoma.
 And Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (Version 1.0, Date 26-Nov-2007).


title: A Phase IIa, Double-blind, Randomised, Placebo-Controlled Dose Escalation Study to Evalulate the Safety, Tolerability, Pharmacokinetics and Activity of GS-9450, a Caspase Inhibitor, in Subjects with Chronic Hepatitis C

lead_sponsor: Gilead Sciences Incorporated


title: A Double-Blind, Randomized, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of two doses of Satavaptan (SR121463B) Versus Placebo in Patients with Dilutional Hyponatremia due to the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)

acronym: AQUARIST I

lead_sponsor: sanofi-aventis recherche et développement


title: Plasma Pharmacokinetics study of CD5024 1% cream in subjects with papulopustular rosacea

lead_sponsor: GALDERMA R&D SNC


title: A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients with Major Depressive Disorder and Associated Painful Physical Symptoms

acronym: Etude HMGR

lead_sponsor: Eli Lilly and Company


title: Phase II Study of Dasatinib (BMS-354825) for Advanced ‘Triple-negative’ Breast Cancer + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 2.0 dated 16-Aug-06) + Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)

lead_sponsor: Bristol-Myers Squibb International Corporation


title:
A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).
 And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07).


title: A  Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multi-center, International Study to Evaluate the Efficacy and Safety of Oxabact(TM) to Reduce Urinary Oxalate in Subjects with Primary Hyperoxaluria.

acronym: Study to see if Oxabact reduces urinary oxalate, the Phoenix study

lead_sponsor: OxThera Inc.


title: A 54 week, randomized, double-blind, parallel-group, multicenter study evaluating the long-term gastrointestinal (GI) safety and tolerability of aliskiren (300 mg) compared to ramipril (10 mg) in patients with essential hypertension

lead_sponsor: Novartis Pharma Services AG


title: An Open-label, Randomized Study of Subcutaneous and Intravenous VELCADE® in Subjects With Previously Treated Multiple Myeloma

lead_sponsor: Janssen-Cilag International NV (JCI)


title: A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Subjects With Advanced Non-Small Cell Lung Cancer


title: “A randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of two doses of ketoprofen (as lysinate) lozenges (6.25mg and 12.5mg ) in patients with sore throat”

acronym: KRYSTAL

lead_sponsor: SANOFI-AVENTIS GROUPE


title: A multi-center, double-masked study of the safety and efficacy of Travoprost APS compared to TRAVATAN in patients with open-angle glaucoma or ocular hypertension.

acronym: Efficacy study of Travoprost APS versus TRAVATAN

lead_sponsor: Alcon Research, Ltd.


title: A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease

lead_sponsor: Impax Laboratories, Inc.


title: A phase II, multinational, multicentre, double blind, double dummy, randomised, 5-way cross-over, placebo and active controlled clinical study to test the non-inferiority of a single dose of CHF 1535 (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg dry powder) via NEXT™ DPI 1 or 4 inhalations versus CHF 1535 (beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg) pMDI with HFA-134a propellant 1 or 4 puffs on FEV1 AUC0-12h in partly controlled adult asthmatic patients

lead_sponsor: Chiesi Farmaceutici S.p.A.


title:
Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/neu-Positive Breast Cancer
 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 dated 16-Aug-06) + Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)


title: Clinical study to investigate the efficacy, the safety and immunogenicity of Wilate in children <6 years of age with inherited von Willebrand disease (VWD)

lead_sponsor: OCTAPHARMA AG


title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis

lead_sponsor: Wyeth Pharmaceuticals France


title: Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults

lead_sponsor: Octapharma AG


title: A RANDOMIZED, DOUBLE BLIND, TWO ARM, PARALLEL, PLACEBO CONTROLLED STUDY OF RIMONABANT 20MG EFFECT ON HIGH DENSITY LIPOPROTEIN KINETICS IN PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS

acronym: HDL TURNOVER

lead_sponsor: sanofi aventis Groupe


title: A 26-week, multinational, multi-centre, open-labelled, two-arm, parallel, randomised, treat-to-target trial comparing efficacy and safety of soluble insulin analogue combination (SIAC) once daily plus meal-time insulin aspart for the remaining meals vs. basal-bolus treatment with insulin detemir plus meal-time insulin aspart in subjects with type 1 diabetes

lead_sponsor: Novo Nordisk A/S


title: An open, randomised, parallel group, multicentre study to compare the efficacy and safety of FlutiForm pMDI vs Seretide pMDI in paediatric subjects with mild to moderate persistent, reversible asthma.

lead_sponsor: Mundipharma Research Ltd.


title: A MULTICENTER, OPEN LABEL SAFETY STUDY OF 2 DOSES OF PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED LESS THAN 12 MONTHS WITH PRESUMED GERD

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development


title: A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer.

acronym: not available

lead_sponsor: Nerviano Medical Sciences S.r.l.


title: Randomized, double-blind, placebo-controlled add-on trial of the safety and efficacy of RO4917838 in outpatients on olanzapine, quetiapine, risperidone or paliperidone with prominent negative or disorganized thought symptoms

lead_sponsor: F.Hoffmann-La Roche Ltd


title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUIRED PNEUMONIA

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development


title: A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF-04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE.

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of central neuropathic pain in subjects with multiple sclerosis.

lead_sponsor: GW Pharma Ltd


title: A 2-YEAR, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO EVALUATE THE LONG-TERM EFFICACY AND SAFETY OF CP-945,598 IN THE TREATMENT OF OBESE SUBJECTS

lead_sponsor: Pfizer Inc.


title: A randomized, open-label, multi-center study of larotaxel at 90mg/m² or docetaxel every 3 weeks, alone or in combination with trastuzumab according to Her2neu status, administered after a combination regimen of anthracycline and cyclophosphamide as pre-operative therapy in patients with high risk localized breast cancer

acronym: SATIN

lead_sponsor: sanofi-aventis recherche & developpement


title: A multicenter, double-blind, parallel-group, placebo-controlled study of the effect on cognitive performance and safety/tolerability of SSR180711C, at the doses of 2, 8 and 20 mg/d for 4 weeks, using donepezil as calibrator, in patients with mild Alzheimer's Disease.

lead_sponsor: sanofi-aventis recherche & développement


title: A MULTICENTER, RANDOMIZED, OPEN LABEL, SINGLE AND MULTIPLE DOSE STUDY OF THE PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSE LEVELS OF  PANTOPRAZOLE SODIUM ENTERIC-COATED SPHEROID SUSPENSION IN INFANTS AGED 1 THROUGH 11 MONTHS WITH PRESUMED GERD.


title: A double-blind, randomized, placebo-controlled, study of the safety and activity of four escalating single doses of AVE0657 in patients suffering from Obstructive Sleep Apnea Hypopnea Syndrome


title: A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD).

lead_sponsor: Novartis Pharma AG


title: A multicenter, Investigator-Masked, Parallel Group, Randomized, Study of the Efficacy and Safety of Indomethacin 0.1% Eyedrops Compared with Ketorolac 0.5% Eyedrops in the Ocular Inflammation After Cataract Surgery.

lead_sponsor: Bausch&Lomb Dr Gerhard Mann chem.-Fabrik GmbH


title: Multicenter, randomized, double-blind, placebo-controlled, Phase IIa study to evaluate the efficacy, safety, and tolerability of ACT-128800, an S1P1 receptor agonist, administered for 6 weeks to subjects with moderate to severe chronic plaque psoriasis

lead_sponsor: Actelion Pharmaceuticals Ltd


title: A randomised controlled parallel group open-label study to evaluate the efficacy and safety of intravenous ferric carboxymaltose versus no treatment in anaemic subjects with multiple myeloma and iron-restricted erythropoiesis receiving chemotherapy

lead_sponsor: Vifor Pharma Inc.


title: A 52 week randomised, controlled, open label, multicentre, multinational, parallel, treat-to-target trial comparing efficacy and safety of SIBA and insulin glargine both administered once daily in a basal-bolus regimen with insulin aspart as mealtime insulin in subjects with type 1 diabetes


title: A 6-Month, Single-Masked, Multicenter, Randomized, Controlled Study to Assess the Safety and Efficacy of 700 μg Dexamethasone Posterior Segment Drug Delivery System Applicator System as Adjunctive Therapy to Lucentis® Compared with Lucentis® Alone in the Treatment of Patients with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

lead_sponsor: Allergan Limited


title: Xenetix 350 : comparative assessment of image quality for coronary CT angiography

acronym: X-ACT study

lead_sponsor: GUERBET


title: A Double-Blind, Placebo-Controlled Study on the Effects of MIN-102 on Biochemical, Imaging, Neurophysiological, and Clinical Markers in Patients with Friedreich’s Ataxia

lead_sponsor: Minoryx Therapeutics BE, SA


title: An eight-week, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of saredutant 100 mg once daily in combination with escitalopram 10 mg once daily in patients with major depressive disorder


title: Randomized parallel-group, multicentre study to evaluate the after-use sensation and safety of carteolol LA 2% versus timolol LA 0.5% in simple intra-ocular hypertension and glaucoma.


title: A PHASE 2 EFFICACY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH NON-SMALL CELL LUNG CANCER AND BRAIN METASTASES

lead_sponsor: Pfizer Inc. - 235 East 42nd Street - New York - 10017


title:
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects with Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control.
 Revised Protocol 01, incorporating Protocol Amendment 02 (Version 1.0, Date 10-Apr-2008). And Pharmacogenetics Blood Sample Amendment 01 - Site specific (Version 2.0, Date 10-Mar-2008).

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week main treatment period and an extension assessing the efficacy and safety of AVE0010 on top of pioglitazone in patients with type 2 diabetes not adequately controlled with pioglitazone.

acronym: GETGOAL-P

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: A Phase 1/2, Multiple-dose, Dose-escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-interleukin 6 (IL-6) Monoclonal Antibody, in Subjects with Solid Tumors

lead_sponsor: Centocor B.V.


title: Effects of three oral dosages of S 44121 on cardiac arrhythmia during exercise testing in patients with catecholaminergic polymorphic ventricular tachycardia type 1. A 3-day, single-blind, international multicentre study.

lead_sponsor: Institut de Recherches Internationales Servier


title: A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis®) in Patients with Localized Myxoid / Round Cell Liposarcoma

lead_sponsor: Pharma Mar, S.A.


title: Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction  and Sexual Quality of Life

acronym: LVGH

lead_sponsor: Lilly ICOS LLC


title: A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl versus Placebo Concurrently with Pemetrexed (Alimta®) as Second Line Therapy in Patients with Advanced or Metastatic Non Small Cell Lung Cancer

lead_sponsor: Eli Lilly and Company limited


title: A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study of Colesevelam as Add-on Therapy in Patients with Familial Hypercholesterolaemia

lead_sponsor: Genzyme Europe BV


title: A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanced or metastatic breast cancer who have progressed while receiving prior therapy

lead_sponsor: F. Hoffmann-la Roche Ltd


title: A Multicentre, Double-blind, Placebo-Controlled, Parallel Group Study of the Effect of Oral Etamsylate (Dicynone®) in Patients with Menorrhagia

acronym: Effects of Oral Etamsylate in Patients with Menorrhagia

lead_sponsor: OM PHARMA


title: Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly subjects

lead_sponsor: Sanofi Pasteur SA


title: A Phase 2 Study of Pembrolizumab (MK 3475) in Subjects with Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

acronym: A phase II study of pembrolizumab in subjects with relapsed or refractory PMBCL

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck  Co., Inc


title: A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 weeks in Men with Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH).

acronym: BPAE

lead_sponsor: Eli Lilly and Company Limited


title: A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or Weekly Bisphosphonates.

lead_sponsor: Amgen Inc


title: A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias.

lead_sponsor: Merck Serono S.A. - Geneva


title: Randomized Phase II study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects with Her2+ Locally Advanced and/or Metastatic Breast Cancer.


title: A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients with Type 1 Diabetes Mellitus

lead_sponsor: Eli Lilly and Company


title: A Randomized, Partially-blind Study to Evaluate the Safety, Tolerability and Effect on Virological Response of Treatment with the HCV Protease Inhibitor RO5190591 in combination with Pegasys and Copegus for 12 or 24 weeks, versus treatment with Pegasys and Copegus alone, in Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection

lead_sponsor: F.Hoffmann-La Roche


title: A Phase 2, Randomized, Open-Label trial of GS-9256 plus GS-9190 alone and in combination with Ribavirin for 28 days in Treatment Naive Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

lead_sponsor: Gilead Sciences Inc


title: A Randomized, 6-Week, Double-Blind, Placebo-controlled, Fixed-Flexible-Dose, Parallel-Group Study of Lurasidone in the Treatment of Bipolar I Depression

lead_sponsor: Dainippon Sumitomo Pharma America Inc.


title: A Phase 2a, 2-Part, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study of Telaprevir in Combination with Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects who Have  Chronic HCV-1/HIV-1 Co-Infection and are Treatment-Naïve for Hepatitis C

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

lead_sponsor: Cephalon, Inc.


title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected with Respiratory Syncytial Virus (RSV)

lead_sponsor: Alnylam Pharmaceuticals, Inc.


title: Nemorubicin hydrochloride (PNU-152243A) administered via intrahepatic artery in combination with cisplatin in adult patients with unresectable hepatocellular carcinoma: Phase II study preceded by dose-escalation.

lead_sponsor: Nerviano Medical Sciences S.r.l.


title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Compare the Efficacy and Safety of Denosumab versus Placebo in Males with Low Bone Mineral Density


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma


title: A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients with Type 2 Diabetes Mellitus on Metformin

acronym: GBCF

lead_sponsor: Eli Lilly and Company - Indianapolis


title: A Randomized, Double Blind Study Evaluating Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus the Combination of Emtricitabine and Tenofovir DF for the Treatment of Chronic Hepatitis B

lead_sponsor: Gilead Sciences Incorporated


title: A prospective multicentre phase II trial of zoledronic acid in patients with myelofibrosis with myeloid metaplasia (MMM)

lead_sponsor: University Hospital Leuven - Department of Haematology


title:
A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

 Etude randomisée de phase Ib/III évaluant le Capivasertib associé au Palbociclib et Fulvestrant versus Placebo associé au Palbociclib et Fulvestrant dans le cancer du sein localement avancé, inopérable ou métastatique, positif aux récepteurs hormonaux (RH+) et négatif au récepteur de facteur de croissance épidermique humain 2 (HER2-) (CAPItello-292)

lead_sponsor: AstraZeneca AB


title: ASPIRO: A Phase 1/2, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT132, an AAV8-Delivered Gene Therapy in X-Linked Myotubular Myopathy (XLMTM) Patients

acronym: ASPIRO

lead_sponsor: Audentes Therapeutics Inc.

status: Temporarily Halted


title: Effectiveness of Somatostatin Analogues in Patients with hereditary hemorrhagic telangiectasia and symptomatic gastrointestinal bleeding, the SAIPAN-trial: a multicenter, randomized, open-label, parallelgroup, superiority trial.

acronym: SAIPAN-trial

lead_sponsor: Radboudumc


title: Phase 3 open-label study to evaluate efficacy, safety, and tolerability of FIX gene transfer with fidanacogene elaparvovec (PF-06838435) in pediatric male participants <18 years of age with moderately severe to severe hemophilia B (FIX:C≤2%) (BeneGene 3)

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: A Randomized, Double Blinded, Multi-Center Study 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination with AMG 386 or Placebo in Subjects with Metastatic Clear Cell Carcinoma of the Kidney

lead_sponsor: Amgen Inc.


title:
A Phase 1b Study Followed by an Open label, Parallel, Randomized Phase 2 Study Evaluating the Safety, Tolerability and Efficacy of GS-5829 in Combination with Exemestane or Fulvestrant Comparing
 with Exemestane or Fulvestrant Alone in Subjects with Advanced Estrogen Receptor Positive HER2- Breast Cancer

lead_sponsor: Gilead Sciences, Inc.


title:
A phase 2, double-blind, randomized safety and efficacy study of Glasdegib (PF-04449913) versus placebo in patients with Myelofibrosis previously treated with ruxolitinib.

 Etude de phase II, randomisée, en double aveugle, évaluant l'innocuité et l'efficacité du Glasdegib (PF-04449913) en comparaison avec un placebo chez des patients atteints de myelofibrose précedemment traités par ruxolitinib.

acronym: Glasdegib (PF-04449913)

lead_sponsor: Pfizer Inc. 235 East 42nd Street, New York, 10017


title: Belatacept Conversion Trial in Renal Transplantation

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis

lead_sponsor: Amgen Inc


title: Randomzied Phase 2 Trial of AG-013736 or Bevacizumab in Combination with Paclitaxel and Carboplatin as First Line Treatment For Patients with Advanced Non-small Cell Lung Cancer

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA


title: A MULTICENTER OPEN LABEL PHASE II STUDY OF THE EFFICACY AND SAFETY OF AMG 479, A FULLY HUMAN MONOCLONAL ANTIBODY AGAINST INSULIN-LIKE GROWTH FACTOR TYPE 1 RECEPTOR (IGF-1R) AS SECOND LINE THERAPY IN PATIENTS WITH RECURRENT PLATINUMSENSITIVE OVARIAN CANCER

lead_sponsor: Cancer International research Group


title: A phase II, open label multicenter trial of panobinostat (LBH589) monotherapy in women with HER2 negative locally recurrent or metastatic breast cancer

lead_sponsor: Cancer International Research Group


title: An open-label randomized phase II trial of belinostat (PXD101) in combination with carboplatin and paclitaxel (BelCaP) compared to carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary

acronym: BelCaP in CUP

lead_sponsor: TopoTarget A/S


title:
A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF MOXR0916 IN COMBINATION WITH
 ATEZOLIZUMAB VERSUS ATEZOLIZUMAB ALONE IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE INELIGIBLE FOR CISPLATIN-BASED THERAPY

lead_sponsor: Genentech, Inc


title: Two Approaches to Escalate Lispro Therapy in Patients with Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone

acronym: AUTONOMY

lead_sponsor: Eli Lilly and Company


title: A Phase 2, Open-Label, Single-Arm, Multidose Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer

lead_sponsor: Millennium Pharmaceuticals, Inc.


title: A Phase II, global, randomized study to evaluate the efficacy and safety of Danirixin (GSK1325756) co-administered with a standard-of-care antiviral (oseltamivir), in the treatment of adults hospitalized with influenza

acronym: GSK1325756, Phase 2, hospitalised Influenza Patients, RD, NAI co-administration, IV, PKPD

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title:
A Randomized-Controlled Three-arm Phase II Study of Lurbinectedin (PM01183) Alone or In Combination with Gemcitabine and a control arm with Docetaxel as Second-Line Treatment in Unresectable Non-Small Cell Lung Cancer (NSCLC) Patients.

 Étude de phase II, randomisée, contrôlée, à trois bras, comparant la lurbinectedine (PM01183) seule ou en association avec la gemcitabine  versus  docétaxel comme traitement de deuxième intention chez des patients atteints de cancer bronchique non à petites cellules (CBNPC) non résécable

acronym: Not applicable

lead_sponsor: Pharma Mar S.A. Sociedad Unipersonal


title: Safety and pharmacokinetics of ODM-207 in patients with selected advanced solid tumours: an open-label, non-randomised, uncontrolled, multicentre, first-in-human study  with cohort expansion

acronym: BETIDES

lead_sponsor: Orion Corporation Orion Pharma


title: A randomized, multicenter, open-label, Phase 2 study with a safety run-in part to evaluate safety, pharmacodynamics and efficacy of azacitidine compared to no anticancer treatment in children and young adults with acute myeloid leukemia in molecular relapse after first complete remission.

lead_sponsor: Celgene Corporation


title: A Phase II (BRF113710) single-arm, open-label study of GSK2118436 in previously treated BRAF mutant metastatic melanoma

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A European, randomised, double-blind, active comparator-controlled, cross-over, efficacy and safety study of a new 10% ready-to-use liquid human intravenous immunoglobulin (I10E) versus Kiovig® in patients with Multifocal Motor Neuropathy

lead_sponsor: LFB BIOTECHNOLOGIES


title:
AN OPEN-LABEL, EXPLORATORY, MULTICENTER, EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF UCB5857 IN SUBJECTS WITH ACTIVATED PHOSPHOINOSITIDE 3 KINASE (PI3K) DELTA SYNDROME (APDS)

 ÉTUDE D’EXTENSION MULTICENTRIQUE, EXPLORATOIRE, OUVERTE, ÉVALUANT LA TOLÉRANCE À LONG TERME, LA SÉCURITÉ D’EMPLOI, LA PHARMACOCINÉTIQUE ET L’EFFICACITÉ DE L’UCB5857 CHEZ DES PATIENTS PRÉSENTANT UN SYNDROME DE PHOSPHO-INOSITIDE-3-KINASE (PI3K) DELTA ACTIVÉE (SYNDROME APDS)

lead_sponsor: UCB BioPharma SPRL


title: A Randomized, Open-label, Multicenter, Multiphase Study of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, Administered in Combination with Daratumumab, Compared with Daratumumab Alone in Subjects with Relapsed or Refractory Multiple Myeloma.

lead_sponsor: Janssen-Cilag International N.V.


title: Efficacy and safety of the fixed oral low-dose perindopril arginine 3.5 mg/amlodipine 2.5 mg combination compared with each component (perindopril arginine 3.5 mg and amlodipine 2.5 mg) and with perindopril arginine 5 mg and amlodipine 5 mg. Randomized, double-blind, placebo-controlled study over 8 weeks in hypertensive patients.

lead_sponsor: Institut de Recherches Internationales Servier


title: A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease

lead_sponsor: Alfa Wassermann S.p.A.


title: PHASE II OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES

lead_sponsor: Pfizer Inc 235 East 42nd Street New York, NY 10017


title: Multicentre, controlled, randomized, investigator-blinded, comparative study of oral  Mesalazine 4g per day Once daily versus 4g per day in Two divided doses  in patients with active Ulcerative colitiS

acronym: MOTUS

lead_sponsor: Ferring SAS


title: RENAL SAFETY EVALUATION AFTER DOTAREM-ENHANCED  MRA COMPARED WITH NON-ENHANCED MRI IN PATIENTS AT HIGH RISK OF DEVELOPING CONTRAST MEDIUM INDUCED NEPHROPATHY.

lead_sponsor: GUERBET


title: Randomised, double-blind, placebo-controlled dose-effect study of V0114 (2.5, 5, 7.5 and 10 mg) versus mequitazine 10 mg and placebo in the treatment of seasonal allergic rhinitis.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: An open-label, multicenter phase II extension of study 28063 (ATAMS) to obtain long-term follow-up data in patients with relapsing multiple sclerosis treated with atacicept for up to 5 years (ATAMS-Extension)

acronym: Atacicept 28063 (RMS) extension study

lead_sponsor: Merck Serono International


title: A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease

lead_sponsor: Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)


title: MULTICENTER PHASE 2 TRIAL OF ARQ 197 FOR SUBJECTS WITH RELAPSED OR REFRACTORY GERM CELL TUMORS

lead_sponsor: Daiichi Sankyo Pharma Development


title: A Phase 3, Randomized , Open-Label, Multicenter Study of the Efficacy and Safety of Pyrotinib versus Docetaxel in Patients with Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) Harboring a HER2 Exon 20 Mutation who progressed on or after Treatment with Platinum Based Chemotherapy

lead_sponsor: Jiangsu Hengrui Medicine Co., Ltd.


title:
Intralesional steroids injections to prevent refractory  strictures in patients with esophageal atresia - a randomized controlled tiral

 Injections intralésionnelles de stéroides pour prévenir les sténoses réfractiares chez les patients atteints d'atrésie de l'oesophage - essai controlé randomisé

acronym: STEPS-EA

lead_sponsor: Erasmus Universitu Medical Center - Sophia Children's Hospital


title: A PHASE II STUDY EVALUATING THE SAFETY AND EFFICACY OF GLOFITAMAB IN COMBINATION WITH RITUXIMAB (R) PLUS CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE (CHOP) IN CIRCULATING TUMOR (ct)DNA HIGH-RISK PATIENTS WITH UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA

lead_sponsor: F.Hoffmann-La Roche Ltd


title: Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer (PETACC-6)

lead_sponsor: EORTC


title: A comparison of ipratropium bromide/salbutamol delivered by the Respimat inhaler to COMBIVENT Inhalation Aerosol and ipratropium bromide delivered by the Respimat in a 12-week, double-blind, safety and efficacy study in adults with chronic obstructive pulmonary disease

acronym: Safety&Efficacy of Comb. Respimat  COPD

lead_sponsor: Boehringer Ingelheim France


title: A multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and tolerability of AVE5530 when added to ongoing stable statin therapy at high doses in patients with severe primary hypercholesterolemia

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: RANDOMIZED MULTICENTER PHASE III STUDY IN PATIENTS WITH LOCALLY ADVANCED ADENOCARCINOMA OF THE PANCREAS: GEMCITABINE WITH OR WITHOUT CHEMORADIOTHERAPY AND WITH OR WITHOUT ERLOTINIB

acronym: LAP 07

lead_sponsor: GERCOR


title: Long-Term Follow-Up (LTFU) of Participants Treated with GSK Adoptive Cell Therapies

acronym: Adoptive cell therapy LTFU study

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title:
A Phase 3b, Open-Label, Single Arm, Multi-Centre Study to Assess the Safety and Efficacy of Pegvaliase (BMN 165) Treatment in adults With Phenylketonuria Not Controlled With Current Management

 Étude de phase 3b, en ouvert, à un seul bras, multicentrique visant à évaluer l’innocuité et l’efficacité du traitement par Pegvaliase (BMN 165) chez des adultes atteints de phénylcétonurie non contrôlée par la prise en charge actuelle

acronym: OPTIC Study

lead_sponsor: BioMarin Pharmaceutical Inc.

status: Not Authorised


title:
A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with Unresectable Hepatocellular Carcinoma (HIMALAYA)

 Etude randomisée, en ouvert, multicentrique de phase III évaluant le Durvalumab et le Tremelimumab en 1ère ligne de traitement chez les patients atteints d’un carcinome hépatocellulaire non résécable (HIMALAYA)

acronym: HIMALAYA

lead_sponsor: AstraZeneca AB


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Voxelotor (GBT440) in Pediatric Participants with Sickle Cell Disease (HOPE Kids 2)

lead_sponsor: Global Blood Therapeutics, Inc.


title:
A Phase II, Open-label, Multicenter, International Study of Durvalumab Following Radiation Therapy in Patients with Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy (DUART)

 Étude de phase 2 internationale, ouverte, multicentrique, évaluant le durvalumab après radiothérapie chez des patients atteints de cancer du poumon non à petites cellules non résécable de stade III qui ne sont pas éligibles à la chimiothérapie (étude DUART)

acronym: DUART


title: PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA

acronym: Vinilo

lead_sponsor: Institut de cancérologie Gustave Roussy


title:
A Non-Interventional Study to Monitor the Survival Status of
 Patients that Discontinued from ISIS 420915-CS2 or
 ISIS 420915-CS3

 Étude non interventionnelle visant à surveiller le statut de survie des patients ayant quitté l'étude ISIS 420915-CS2 ou ISIS 420915-CS3

lead_sponsor: Ionis Pharmaceuticals, Inc.


title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN CISPLATIN-INELIGIBLE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY (MORPHEUS-mUC)

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects with Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)

acronym: Phase II Study of Pembrolizumab in Subjects with MMRd or MSI-H CRC

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants with Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

acronym: Mogamulizumab Q4week dosing in Participants with R/R CTCL

lead_sponsor: Kyowa Kirin Inc.


title: A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species.

lead_sponsor: F2G Ltd.


title: A randomized, open-label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised subjects (PRIOH-1)

lead_sponsor: AiCuris Anti-infective Cures GmbH


title:
An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies

 Étude d’innocuité, multicentrique, ouverte comparant, à dose fixe, l’association durvalumab-trémélimumab à la monothérapie par durvalumab dans les tumeurs solides à stade avancé (Etude STRONG)

acronym: STRONG


title: A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease.

lead_sponsor: bluebird bio, Inc.


title:
A Phase 3 Study of Adjunctive XEN496 in Pediatric Subjects with KCNQ2 Developmental and Epileptic Encephalopathy

 Étude de phase III évaluant le XEN496 en traitement adjuvant chez des patients pédiatriques atteints d’encéphalopathie épileptique et développementale associée à KCNQ2

acronym: EPIK

lead_sponsor: Xenon Pharmaceuticals Inc.


title: A Randomized, Parallel-Arm, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Friedreich ataxia (MOVE-FA)

acronym: MOVE-FA

lead_sponsor: PTC Therapeutics, Inc.


title:
A Phase III, Open-label, Randomized Study of Osimertinib with or without Platinum Plus Pemetrexed Chemotherapy, as First-line Treatment in Patients with Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2)

 Étude de phase III, en ouvert, randomisée, évaluant l’osimertinib avec ou sans chimiothérapie à base de platine associée au pémétrexed, en traitement de première ligne chez les patients atteints d’un cancer du poumon non à petites cellules avec mutation du récepteur du facteur épidermique de croissance (EGFR) localement avancé ou métastatique (FLAURA2)


title: An open-label, multicenter study in male pediatric patients with cerebral X-linked Adrenoleukodystrophy (cALD) to assess the effect of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)

lead_sponsor: Minoryx Therapeutics S.L.


title: A Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment followed by surgery versus surgery alone in clinical stage IIIB and IIIC melanoma patients.

acronym: Neoadjuvant L19IL2/L19TNF- Pivotal study

lead_sponsor: Philogen S.p.A.


title:
A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term  Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1

 Étude d'extension de phase II, multicentrique, en ouvert, visant à évaluer l'administration à long terme d'ALN-GO1 chez des patients atteints d'hyperoxalurie primitive de type 1

lead_sponsor: Alnylam Pharmaceuticals, Inc.


title:
Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects with Epileptic Encephalopathy with Continuous Spike-and-Wave During Sleep

 Étude de phase 2, multicentrique, randomisée, en double aveugle, contrôlée par placebo et en groupes parallèles, visant à évaluer l’efficacité, l’innocuité, la tolérance et la pharmacocinétique du NBI-827104 chez des patients pédiatriques atteints d’encéphalopathie épileptique avec pointes-ondes continues au cours du sommeil

lead_sponsor: Neurocrine Biosciences, Inc.


title: A 24-WEEK MULTICENTRE, RANDOMISED, DOUBLE BLIND, CONTROLLED, PARALLEL GROUP NON-INFERIORITY STUDY TO ASSESS THE EFFICACY AND SAFETY OF OLMESARTAN MEDOXOMIL VERSUS CANDESARTAN CILEXETIL IN PATIENTS WITH SYMPTOMATIC HEART FAILURE (NYHA II-IV)

acronym: OLMEBNP

lead_sponsor: DAIICHI SANKYO EUROPE GmbH


title: A Phase 2 Randomized, Multi-center, Double-blind, Vehicle-controlled, 12-Week, Safety, Efficacy, and Systemic Exposure Study followed by a 12-Week Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents with Autosomal Recessive Ichthyosis with Lamellar Scale

lead_sponsor: Mayne Pharma


title: A randomized phase II, open-label multicenter trial of panobinostat monotherapy in women with HER2 positive locally recurrent or metastatic breast cancer

lead_sponsor: Cancer International Research Group


title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER STUDY OF THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF Apo2L/TRAIL ADMINISTERED INTRAVENOUSLY IN COMBINATION WITH RITUXIMAB TO SUBJECTS WITH FOLLICULAR AND OTHER LOW-GRADE, CD20+, B-CELL NON-HODGKIN’S LYMPHOMAS THAT HAVE PROGRESSED FOLLOWING PREVIOUS RITUXIMAB THERAPY

lead_sponsor: Genentech Inc.


title: Essai multicentrique prospectif randomisé en double aveugle et en groupes parallèles, destiné à évaluer les effets de doses ascendantes de BF2.649 et de BF2.649 combiné à du modafinil dans le traitement de la cataplexie chez des patients narcoleptiques

acronym: Harmony II

lead_sponsor: Bioprojet


title: Essai multicentrique prospectif randomisé en double aveugle contre placebo et en groupes parallèles, destiné à évaluer les effets du BF2.649 dans le traitement de la somnolence diurne excessive associée à une narcolepsie

acronym: Harmony I


title: A Randomized, Double blind, Placebo-Controlled Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury

lead_sponsor: Solvay Pharmaceuticals B.V.


title: Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID)

lead_sponsor: Octapharma AG


title: A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury

lead_sponsor: Cephalon Inc.


title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of Enzastaurin with 5 FU/LV plus Bevacizumab as Maintenance Regimen Following First Line Therapy for Metastatic Colorectal Cancer

lead_sponsor: Eli Lilly and Company limited


title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel- Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

lead_sponsor: Dainippon Sumitomo Pharma America Inc.


title: AN EXPLORATIVE PHASE IIa STUDY TO ASSESS SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF VAS203 IN PATIENTS WITH MODERATE AND SEVERE TRAUMATIC BRAIN INJURY

lead_sponsor: vasopharm GmbH


title: Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia


title:
Phase 1/2 Study Of Intratumoral G100 With Or Without Pembrolizumab In Patients With Follicular Non-Hodgkin’s Lymphoma

 Étude de Phase I/II sur le G100 en injection intratumorale avec ou sans le pembrolizumab chez des patients porteurs de lymphome non hodgkinien folliculaire

lead_sponsor: Immune Design Ltd


title: A randomised, double-blind, double-dummy, placebo-controlled, parallel-group study to assess and compare efficacy and safety of an 8-week treatment with BI 54903 at doses of 45.5, 90.9 and 181.8 μg b.i.d. administered via Respimat® inhaler and fluticasone propionate HFA MDI 220 μg b.i.d. in patients with asthma inadequately controlled on low dose ICS therapy.

lead_sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG,


title: An open label, prospective, multicenter trial, on the effect of anti-TNF alpha Chimeric monoclonal antibody (Infliximab, Remicade) on the inflammatory and fibrous lesions in patients with intestinal Crohn's Disease.

lead_sponsor: CHRU de Lille


title: A Phase III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)- positive oropharyngeal cancer

acronym: Post-operative adjuvant treatment for HPV-positive tumours (PATHOS)

lead_sponsor: Cardiff University


title: A Phase I/II randomised therapeutic HIV vaccine trial in individuals who started antiretrovirals during primary or chronic infection.

lead_sponsor: Inserm-ANRS


title: A MULTICENTER, OPEN-LABEL PHARMACOKINETIC, PHARMACODYNAMIC, CLINICAL SYMPTOMS, AND SAFETY STUDY OF PANTOPRAZOLE DELAYED-RELEASED GRANULES ADMINISTERED AS A SUSPENSION IN NEONATES AND PRETERM INFANTS WITH A CLINICAL DIAGNOSIS OF GASTROESOPHAGEAL REFLUX DISEASE

lead_sponsor: Wyeth Research, Clinical Research and Development, Division of Wyeth Pharmaceuticals Inc.


title: A double-blind, double-dummy, randomized, parallel groups study to assess the Efficacy, Safety and Tolerability of switching patients with early Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ER or Pramipexole IR.

lead_sponsor: BOEHRINGER INGELHEIM


title: An Exploratory, Multi-center, Open-Label, Single-Arm study to evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent (DECADES) on Inflammatory and Platelet Activation Markers in Subjects Who Are Receiving Low Dose Acetylsalicylic Acid (ASA).

acronym: DECADES

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with Severe Asthma

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A RANDOMIZED, PARTIALLY-BLINDED, MULTI-CENTER, ACTIVE-CONTROLLED, DOSE RANGING STUDY ASSESSING THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO UNFRACTIONATED HEPARIN OR LOW MOLECULAR HEPARIN IN SUBJECTS WITH ACUTE CORONARY SYNDROME

acronym: RADAR

lead_sponsor: Regado Biosciences, Inc


title: A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer

lead_sponsor: Novartis Pharma AG


title: International phase I/II expansion trial of the MEK inhibitor selumetinib in combination with dexamethasone for the treatment of relapsed/refractory RAS-pathway mutated paediatric and adult Acute Lymphoblastic Leukaemia

acronym: Seludex

lead_sponsor: University of Birmingham


title: A Placebo-Controlled, Single-Blind, Single-Center Phase 1 Study in Normal Healthy Volunteers and Open-Label Multi Center Study in Patients with Primary Hyperoxaluria to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DCR PHXC Solution for Injection (subcutaneous use)

acronym: 2-part study of DCR-PHXC in NHV and PH patients

lead_sponsor: Dicerna Pharmaceuticals Inc


title: Rituximab as second line treatment for ITP: A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study. “The RITP study”

acronym: RITP study

lead_sponsor: Rikshospitalet


title: A double-blind, randomized phase II study of once daily versus twice daily PTK787/ZK 222584 treatment in patients with advanced, previously treated metastatic adenocarcinoma of the colon or rectum

acronym: Comparison of once daily versus twice daily administration of PTK787/ZK 222584 in mCRC

lead_sponsor: Schering AG


title: A multicenter, randomized, open label phase II trial evaluating the efficacy and safety of mFOLFOX7 plus weekly alternating sequential oral administration of BIBF 1120 250 mg twice daily and BIBW 2992 50 mg once daily (BB) versus mFOLFOX7 alone as first-line therapy in patients with metastatic colorectal cancer.

lead_sponsor: Boehringer Ingelheim France SAS


title: Comparison of the safety and efficacy of volinanserin and lormetazepam in the treatment of insomnia characterized by sleep maintenance difficulties. A 4 week, randomized, double-blind, double-dummy, comparative, parallel-group study.

acronym: REST

lead_sponsor: sanofi-aventis recherche & développement


title: A double-blind, randomized, placebo-controlled, study evaluating the safety and activity of four escalating single doses of AVE0657 in congestive heart failure patients presenting as Cheyne-Stokes Breathing Syndrome


title: Phase 1b/2, Multicenter, Open-label Study of Carfilzomib, Carboplatin, and Etoposide in Subjects with Previously Untreated Extensive-stage Small-cell Lung Cancer

lead_sponsor: Onyx Therapeutics, Inc.


title: Multicenter, randomized, open label study evaluating an anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) monoclonal antibody, AVE1642, administered every 4 weeks in combination with fulvestrant (Faslodex®) in postmenopausal patients with advanced hormono-dependent breast cancer

lead_sponsor: sanofi-aventis recherche et développement


title: A multicentre, multinational, randomised, double-blind, placebo-controlled, 3-arm, 24-week parallel-group study to evaluate the safety, tolerability and preliminary efficacy of ORY-2001 in patients with mild-moderate Alzheimer's Disease. ETHERAL Study

acronym: ETHERAL

lead_sponsor: Oryzon Genomics S.A.


title: A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)

lead_sponsor: Karyopharm Therapeutics Inc.


title: A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19

acronym: Phase 3 Double-blind study of AZD7442 or Placebo for Pre-exposure Prophylaxis of COVID-19 in Adults

lead_sponsor: AstraZeneca AB


title: Phase I/II gene transfer clinical trial of rAAV9.CMV.hNAGLU for Mucopolysaccharidosis (MPS) IIIB

lead_sponsor: Abeona Therapeutics Europe SL.


title:
A placebo-controlled, patient and investigator blinded, randomized parallel
 cohort study to assess pharmacodynamics, pharmacokinetics, safety,
 tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in
 patients with systemic lupus erythematosus (SLE)

 Étude randomisée, en double aveugle contre placebo, en groupes parallèles visant à évaluer la pharmacodynamie, la pharmacocinétique, la sécurité, la tolérabilité et l'efficacité clinique préliminaire de VAY736 et CFZ533 chez des patients atteints de lupus érythémateux disséminé


title: A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD)

lead_sponsor: Shire Human Genetic Therapies Inc


title: A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients

acronym: Intramuscular VIR-7831 (sotrovimab) for mild/moderate COVID-19 Study Phase: Phase III

lead_sponsor: Vir Biotechnology, Inc.


title: An open label, multi-centre, phase I/IIa study evaluating the safety and clinical activity of neoantigen reactive T cells in patients with advanced non-small cell lung cancer.

acronym: ATX-NS-001 - ATL001 for the Treatment of Non-Small Cell Lung Cancer

lead_sponsor: Achilles Therapeutics Limited


title:
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined with KRT-232 in Subjects with Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)

 Étude de phase 1b/2, multicentrique, en ouvert visant à évaluer l'innocuité et l'efficacité du TL-895 en association avec le KRT-232 chez des patients atteints de leucémie aiguë myéloïde (LAM) FLT3+ récidivante/réfractaire (R/R)

lead_sponsor: Telios Pharma, Inc.


title: A Phase 1/2, open-label, multicenter, dose escalation and dose expansion study of NKTR-214 and Nivolumab in patients with select locally advanced or metastatic solid tumor malignancies

lead_sponsor: Nektar Therapeutics


title: A Randomised Active-controlled Study to Compare Efficacy and Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) to Intravenous Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years Old

acronym: IsoCOMFORT study

lead_sponsor: Sedana Medical AB


title: A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months

lead_sponsor: Dova Pharmaceuticals, Inc.


title: A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of DCR-PHXC in Patients With Primary Hyperoxaluria Type 1 or 2 and Severe Renal Impairment, With or Without Dialysis

acronym: PHYOX 7: Safety & Efficacy of DCR-PHXC in patients with PH1/2 and ESRD

lead_sponsor: Dicerna Pharmaceuticals Inc


title:
A Multicenter, Randomized,  Open-label, Crossover, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of IgPro20  (subcutaneous immunoglobulin, Hizentra®) and IgPro10 (intravenous immunoglobulin, Privigen®) in  Adults with Systemic Sclerosis (SSc).

 Étude de phase II multicentrique, randomisée, menée en ouvert, avec permutation des traitements, visant à évaluer la sécurité d’emploi et la pharmacocinétique de l’IgPro20 (immunoglobuline injectable par voie sous-cutanée, Hizentra®) et de l’IgPro10 (immunoglobuline injectable par voie intraveineuse, Privigen®) chez des patients adultes atteints de sclérodermie systémique (ScS).

lead_sponsor: CSL Behring GmbH


title: A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)

acronym: EPITOPE

lead_sponsor: DBV TECHNOLOGIES S.A.


title:
An Open-Label Extension Study of XEN496 in Pediatric Subjects with KCNQ2 Developmental and Epileptic Encephalopathy

 Étude d’extension en ouvert évaluant le XEN496 chez des patients pédiatriques présentant une encéphalopathie épileptique et développementale associée à KCNQ2

acronym: EPIK OLE

lead_sponsor: Xenon Pharmaceuticals Inc.


title:
A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in  the Treatment of Adult Subjects with Generalized Pustular Psoriasis

 Extension d’une étude clinique de phase III visant à évaluer l’efficacité et la tolérance à long terme de l’Imsidolimab (ANB019) dans le traitement de patients adultes atteints d’un Psoriasis Pustuleux Généralisé

acronym:
Long-Term Safety and Efficacy of Imsidolimab in Subjects with Generalized Pustular Psoriasis

 Sécurité et efficacité à long terme de l'Imsidolimab sur un Psoriasis Pustuleux Généralisé

lead_sponsor: AnaptysBio Inc.


title:
A RANDOMIZED, DOUBLE-BLIND, MULTICENTER,
 PLACEBO-CONTROLLED PHASE 3 STUDY WITH
 OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY
 AND SAFETY OF INEBILIZUMAB IN ADULTS WITH
 MYASTHENIA GRAVIS

acronym: Myasthenia Gravis INebilizumab Trial (MINT)

lead_sponsor: Viela Bio, Inc.


title: A three-period multicenter study, with a randomized withdrawal, double-blinded, placebo-controlled design in Period 2 to evaluate the clinical efficacy, safety and tolerability of MAS825 in NLRC4-GOF patients

lead_sponsor: Novartis Pharma AG


title: Phase II trial of nivolumab for pediatric and adult relapsing/refractory ALK+ anaplastic large cell lymphoma, for evaluation of response in patients with progressive disease (Cohort 1) or as consolidative immunotherapy in patients in complete remission after relapse (Cohort 2)

acronym: NIVO-ALCL

lead_sponsor: Gustave Roussy


title:
Double-blind, vehicle-controlled, randomized, multi-centre study to evaluate the efficacy and safety of LH-8 cutaneous solution in children and adolescents with moderate to severe scalp alopecia areata

 Étude multicentrique en double aveugle, contre placebo et randomisée, visant à évaluer l’efficacité et l’innocuité de la solution cutanée LH-8 chez les enfants et adolescents atteints d’une pelade du cuir chevelu modérée à sévère

lead_sponsor: Legacy Healthcare (France) SAS


title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)

acronym: Meteoroid

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
A Phase 3b Open-label Study of the Anti-FGF23 Antibody,
 Burosumab (KRN23) in Adult Patients with X-linked
 Hypophosphatemia (XLH)

 Étude de phase IIIb en ouvert sur l'anticorps anti-FGF23, le burosumab
 (KRN23), chez des adultes atteints d'hypophosphatémie liée à l'X (ou XLH
 pour X-linked Hypophosphatemia)

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd


title:
A RANDOMISED, SINGLE-BLIND, ACTIVE CONTROLLED, MULTI-CENTRE TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, ACCEPTABILITY AND PALATABILITY OF PMF104 COMPARED TO A CONVENTIONAL PEG-ELECTROLYTE SOLUTION IN CHILDREN  AGED FROM 2 TO LESS THAN 6, FROM 6 TO LESS THAN 12 AND ADOLESCENTS FROM 12 TO LESS THAN 18 YEARS OF AGE REQUIRING A DIAGNOSTIC PROCEDURE CONCERNING THE COLON (EMA Decision P/019/2017 on the acceptance of modification of Paediatric Investigation Plan)

 Essai multicentrique, randomisé, en simple aveugle, contrôlé par substance active, visant à évaluer l’efficacité, la sécurité d’emploi, la tolérance, l’acceptabilité et la palatabilité du PMF104 par comparaison à une solution électrolytique conventionnelle contenant du PEG, chez des enfants âgés de 2 ans à moins de 6 ans, de 6 ans à moins de 12 ans et chez des adolescents âgés de 12 ans à moins de 18 ans, devant subir une procédure à visée diagnostique concernant le côlon  (Décision de l’EMA P/019/2017 relative à l’approbation de modification du Plan d’Investigation Pédiatrique)

lead_sponsor: Alfa Wassermann S.p.A.


title: Adaptive design phase 2 to 3, randomized, double- blind, multicenter, to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BIO101 in the prevention of the respiratory deterioration in hospitalized patients with COVID-19 pneumonia (severe stage)

lead_sponsor: Biophytis S.A.


title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

 Étude de phase 2, randomisée, en double aveugle et contrôlée par placebo, visant à évaluer l’efficacité et l’innocuité de la Pimavansérine dans le traitement de l’irritabilité associée au trouble du spectre de l’autisme

lead_sponsor: Acadia Pharmaceuticals Inc.


title: Exploratory study of the safety, tolerability and efficacy of nangibotide in mechanically ventilated patients with COVID-19 and features of systemic inflammation - A randomized, double-blind, placebo-controlled study with adaptive features.

lead_sponsor: INOTREM S.A.


title:
A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction with Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 2 Years and Older) with Mild-to-Moderate Atopic Dermatitis, who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment

 Étude de phase 3, randomisée, en double aveugle, contrôlée par placébo, évaluant l’efficacité et la tolérance du traitement d’entretien et de la réduction des poussées par crisaborole, pommade à 2 %, une fois par jour pendant 52 semaines chez l’adulte et l’enfant (à partir de 2 ans) présentant une dermatite atopique légère à modérée, ayant répondu au traitement deux fois par jour par crisaborole, pommade à 2 %

acronym: CrisADe Control

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: An Open-Label, Single-Arm, Multicenter Study of Intracerebral Administration of Adeno-Associated Viral Vectors Serotype rh10 Carrying the Human N-sulfoglucosamine sulfohydrolase (SGSH) cDNA for the Treatment of Mucopolysaccharidosis Type IIIA

lead_sponsor: Lysogene SA


title: A Phase IIb, randomized, partially blind, active controlled, dose-range finding study of GSK3640254 compared to a reference arm of dolutegravir, each in combination with nucleoside reverse transcriptase inhibitors, in HIV-1 infected antiretroviral treatment-naive adults

acronym: A Phase 2b Dose-Range Finding Clinical Trial in HIV-1 Infected Treatment-Naive Adults

lead_sponsor: ViiV Healthcare UK Limited


title: Evaluation de l’effet anesthésique du protoxyde d’azote dans une population d’opérés recevant une anesthésie totale intraveineuse en « boucle » guidée par l’index bispectral (Effect of nitrous oxide on intra-venous closed-loop anesthesia)

acronym: Drone-Proto

lead_sponsor: Hopital Foch


title: Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve week comparison versus local treatment with Ringer solution. A randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase IIIb study

lead_sponsor: Schülke & Mayr GmbH


title: A Human Clinical Trial to Evaluate the Safety and Clinical Utility of GEM OS1 as a Bone Regeneration System in Foot and Ankle Arthrodesis Procedures

lead_sponsor: BioMimetic Therapeutics, Inc


title: Open-label, Dose escalation, followed by Double-blind, Randomized, Two-dose, Parallel Group, Multi-center Clinical Trial of HuMax-CD4, a Fully Human Monoclonal Anti-CD4 Antibody, in Patients with Mycosis Fungoides type CTCL (stage IB-IVB) who are Refractory or Intolerant to Targretin® (bexarotene) and one other Standard Therapy

acronym: HuMax-CD4 in Refractory Mycosis Fungoides

lead_sponsor: Genmab A/S


title: A Double-Masked, Placebo-Controlled, Multi-Centre, Parallel Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Clinically Quiescent Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis.

lead_sponsor: Lux Biosciences GmbH


title: A Double-Masked, Placebo-Controlled, Parallel Group, Multi-Centre, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Active Sight Threatening, Non-Infectious Anterior Uveitis.


title: A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis.


title: A non-comparative open pilot trial to assess the safety and pharmacokinetics of up to three single doses of AERUMAB 11 in patients with ventilator associated pneumonia caused by serotype O11 P. aeruginosa

lead_sponsor: Kenta Biotech Ltd


title: Prospective Phase II Pilot study of Rabbit Antithymocyte globulin (ATG, Thymoglobuline®, Genzyme) with Ciclosporin for Patients with Acquired Aplastic Anaemia and comparison with matched historical patients treated with horse ATG and Ciclosporin

lead_sponsor: EBMT (European group for Blood and Marrow Transplantation)


title: A Randomized, Open-Label Study Comparing the Effectiveness of Olanzapine Pamoate Depot with Haloperidol Decanoate in the Treatment of Schizophrenia

acronym: HGMT

lead_sponsor: Eli Lilly and Company Limited


title: Etude ATOLL . Etude internationale, multicentrique, visant à comparer l'utilisation de l'enoxaparine IV versus héparine standard IV chez les sujets présentant un infarctus du myocarde aigu et nécessitant l'intervention coronarienne  percutanée primaire

acronym: ATOLL

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

lead_sponsor: Acadia Pharmaceuticals Inc


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic

lead_sponsor: Rigel Pharmaceuticals, Inc.


title: A Phase 3, Open-label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion from Prograf® Capsules Twice Daily to LCP-Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients

lead_sponsor: LifeCycle Pharma A/S


title: A phase 2B, randomised, double-blind, placebo-controlled, parallel group, multi-centre study to investigate the efficacy, mechanism of action, pharmacokinetics, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 as monotherapy in patients with Gastroesophageal Reflux Disease (GERD)

lead_sponsor: Addex Pharma SA


title: A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multi-centre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 in patients with Gastroesophageal Reflux Disease (GERD) who are partial responders to proton pump inhibitor (PPI) treatment.


title: A Multi-Centre, Randomized, Placebo-controlled, Parallel-Group, double-Blinded Study to Compare the Therapeutic Efficacy, Safety and Tolerability of 3 Single Vaginal Doses of Arasertaconazole Nitrate pessaries in the Treatment of Vulvovaginal Candidiasis

lead_sponsor: Ferrer Internacional, S.A


title: SELECT-2: Phase 2B, Partially Blinded, Randomized Study In Treatment Naïve Subjects With HCV Genotype 1 To Compare The Efficacy, Safety, And Tolerability Of Three Doses of Locteron™ Plus Ribavirin Given Bi-weekly In Comparison With PEG-Intron™ Plus Ribavirin Given Weekly

lead_sponsor: Biolex Therapeutics Inc.


title: A multi-center, randomized, double-blind, controlled dose-finding study to evaluate the safety and efficacy of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock

lead_sponsor: Sangart, Inc.


title: A Phase IIa randomised, double-blind, placebo controlled, parallel group,  multicentre study evaluating the efficacy, safety, tolerability and pharmacokinetics of AZD1386 after 3 weeks of treatment in patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)

lead_sponsor: AstraZeneca AB


title: AN INTERNATIONAL  PHASE III RANDOMISED TRIAL COMPARING  THE PROPOFOL CONSUMPTION DURING GENERAL ANAESTHESIA WITH XENON IN INSPIRATORY CONCENTRATIONS OF 50 % AND 70% AND TOTAL IV ANAESTHESIA ALONE IN ASA III PATIENTS WITH STABLE CORONARY HEART DISEASE

acronym: General anaesthesia with xenon

lead_sponsor: AIR LIQUIDE


title: A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.

lead_sponsor: European Organization for Research and Treatment of Cancer


title:
A phase I/II multi-center study of HDM201 added to chemotherapy in adult subjects with relapsed/refractory (R/R) or newly diagnosed acute myeloid leukemia (AML)

 Etude de phase I/II, multicentrique, évaluant HDM201 associé à un traitement par chimiothérapie chez des patients adultes atteints de leucémie aiguë myéloïde (LAM) en rechute ou réfractaire (R/R) ou nouvellement diagnostiquée

lead_sponsor: Novartis Pharma AG


title: A Phase IIa, open-label, dose-titration, multicentre study to assess the safety and preliminary efficacy of NI-0401 in patients with acute cellular renal allograftt rejection

lead_sponsor: NovImmune S.A.


title: A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension

acronym: FUTURE 5

lead_sponsor: Actelion pharmaceuticals Ltd


title: An Open-label, International, Multi-Center, Phase I/II, Dose-escalation Trial Investigating the Safety of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Combination with Radiotherapy, in Patients with Stage III, IVa or IVb Locally Advanced Squamous Cell Carcinoma of the Head and Neck Ineligible for Platinum based Chemotherapy

acronym: Zalutumumab in combination with radiotherapy in SCCHN patients ineligible for platinum based chemoth

lead_sponsor: Genmab A/S


title: A Randomized, Rater-Blinded Study to Explore the Effect of  Mefloquine in Subjects with Progressive Multifocal Leukoencephalopathy (PML)

lead_sponsor: Biogen Idec Ltd


title: A Phase 1b/2 Multicenter, Open-label, Expansion Study to Assess the Safety and Efficacy of AMG 420 as Monotherapy in Subjects With Relapsed and/or Refractory Multiple  Myeloma

lead_sponsor: Amgen Inc


title: A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

lead_sponsor: Janssen Vaccines & Prevention B.V.


title: A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination with Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)

lead_sponsor: Innovent Biologics (Suzhou) Co., Ltd.


title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in subjects with Alcoholic Hepatitis

lead_sponsor: DURECT Corporation


title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

acronym: Parsaclisib Rollover study

lead_sponsor: Incyte Corporation


title:
OPEN LABEL, MULTICENTER PHASE II STUDY OF THE C5A-ANTIBODY IFX-1 ALONE OR IFX-1 + PEMBROLIZUMAB IN PATIENTS WITH PD-1- OR PD-L1-RESISTANT/REFRACTORY LOCALLY ADVANCED OR METASTATIC CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)

 Étude de phase 2, multicentrique, en ouvert visant à évaluer l’IFX-1, un anticorps anti-C5a, administré en monothérapie ou en association avec le pembrolizumab chez des patients présentant un carcinome épidermoïde cutané (CEC) localement avancé ou métastatique résistant/réfractaire aux anticorps anti-PD-1 ou anti-PD-L1

lead_sponsor: InflaRx GmbH


title:
A Phase 2, Open-Label, Single-Arm, Multi-Center Study of AL101 in Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations

 Étude de phase 2 multicentrique ouverte à un seul bras visant à évaluer l’AL101 chez des patients atteints de carcinome adénoïde kystique (CAK) présentant des mutations activant la voie Notch

acronym: ACCURACY Study

lead_sponsor: Ayala Pharmaceuticals, Inc.


title:
A randomized, double-blind, placebo-controlled, two parallel groups, international multicenter trial to evaluate the effect of Plerixafor in acute respiratory failure related to COVID-19 (LEONARDO)

 Un essai clinique multicentrique international randomisé, en double aveugle, contrôlé par placebo, à deux groupes parallèles pour évaluer l'effet du plérixafor dans l'insuffisance respiratoire aiguë liée à la COVID-19 (LEONARDO)

acronym: LEONARDO

lead_sponsor: 4Living Biotech SAS


title: A Prospective Study on 18F-DCFPyL PET/CT Imaging in Biochemical Recurrence of Prostate Cancer

acronym: PYTHON

lead_sponsor: CYCLOPHARMA


title: An Open Label Extension Study of GBT440 Administered Orally to Patients with Sickle Cell Disease Who Have Participated in GBT440 Clinical Trials

lead_sponsor: Global Blood Therapeutics, Inc.


title:
A phase II, multicenter, open-label, randomized-controlled trial evaluating the efficacy and safety of a sequencing schedule of cobimetinib plus vemurafenib followed by immunotherapy with an anti- PD-L1 antibody atezolizumab for the treatment in patients with unresectable or metastatic BRAF V600 mutant melanoma.

 Essai clinique multicentrique, ouvert et randomisé de phase II visant à déterminer l’efficacité et la sécurité d'une thérapie séquentielle à base de cobimétinib et de vémurafénib, suivie d’une immunothérapie par anticorps anti-PD-L1 atézolizumab pour traiter des patients présentant un mélanome inopérable ou métastatique avec mutation BRAFV600.

acronym:
ImmunoCobiVem

 ImmunoCobiVem

lead_sponsor: University Hospital Essen


title:
Treatment of High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of  Intravesical BCG Instillations Versus Reduced Number of Intravesical Instillations with Standard Dose of BCG.  A European Association of Urology Research Foundation Randomised Phase III Clinical Trial.

 Etude randomisée comparant le traitement standard de 15 instillations par BCG thérapie à un traitement allégé de 9 instillations chez les patients porteurs d’une tumeur de vessie n'infiltrant pas le muscle. Etude NIMBUS

acronym: NIMBUS

lead_sponsor: EAU Foundation for Urological Research


title: A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNα-Kinoid in adult patients with Systemic Lupus Erythematosus.

acronym: IFN-Kinoid in Systemic Lupus Erythematosus

lead_sponsor: Neovacs SA


title: Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic Leukaemia

lead_sponsor: Institut de Recherches Internationales Servier


title: A prospective, open-label, genotype-match controlled, multicenter clinical trial to investigate the efficacy and safety of intra-amniotic ER004 as a prenatal treatment for male subjects with X-linked hypohidrotic ectodermal dysplasia (XLHED)

lead_sponsor: Pierre Fabre Médicament


title: A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate the Pharmacokinetics and Safety of Solriamfetol in Pediatric Subjects  with Narcolepsy

lead_sponsor: Jazz Pharmaceuticals, Inc.


title: A Phase 1 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of DCR-PHXC in Patients with Primary Hyperoxaluria Type 3

lead_sponsor: Dicerna Pharmaceuticals, Inc.


title:
SHAMAL: A Multicentre, Randomised, Open-Label, Parallel-Group, Active-Controlled, Phase IV Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients with Severe Eosinophilic Asthma Treated with Benralizumab

 SHAMAL : Étude de Phase IV multicentrique, randomisée, menée en ouvert, avec groupes parallèles, contrôlée versus traitement actif, évaluant la réduction du traitement d’entretien quotidien par ICS/LABA en faveur d'un traitement anti-inflammatoire de crise chez des patients présentant un asthme éosinophilique sévère traités par benralizumab

acronym: SHAMAL

lead_sponsor: AstraZeneca AB


title:
A Phase 3/4, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects with Nonalcoholic Steatohepatitis (NASH)
 The ARMOR Study

lead_sponsor: Galmed Research and Development, Ltd.


title: An open-label study to provide berotralstat access to subjects with type 1 and 2 hereditary angioedema who were previously enrolled in berotralstat studies

lead_sponsor: BioCryst Pharmaceuticals Inc


title:
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS

 Étude randomisée, en double aveugle, contrôlée contre placebo évaluant l’ALPN-101 dans le lupus érythémateux disséminé (LED)

lead_sponsor: Alpine Immune Sciences, Inc.


title: A PHASE II, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACODYNAMIC EFFECTS OF ONCE WEEKLY ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH EARLY (PRODOMAL TO MILD) ALZHEIMER'S DISEASE

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
MOUNTAINEER: A Phase 2, Open Label Study of Tucatinib Combined with Trastuzumab in Patients with HER2+ Metastatic Colorectal Cancer

 MOUNTAINEER : Étude de phase 2, en ouvert portant sur le tucatinib associé au trastuzumab chez des patients atteints de cancer colorectal métastatique HER2+

lead_sponsor: Seattle Genetics, Inc.


title: Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Biliary Atresia after Hepatoportoenterostomy

acronym: EMBARK: Evaluation of Maralixibat in Biliary Atresia Response post Kasai

lead_sponsor: Mirum Pharmaceuticals Inc.


title:
A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents with Irritability Associated with Autism Spectrum Disorder (ASD)

 Étude de prolongation ouverte de 52 semaines évaluant la Pimavansérine chez les enfants et les adolescents atteints d’irritabilité associée au trouble du spectre de l’autisme (TSA)

lead_sponsor: Acadia Pharmaceuticals Inc.


title:
A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK)

 Étude de phase 3, multinationale, randomisée, en double aveugle, contrôlée par placebo, sur le transfert systémique de gènes, visant à évaluer la sécurité d’emploi et l’efficacité du SRP-9001 chez des sujets atteints de dystrophie musculaire de Duchenne (EMBARK)

lead_sponsor: Sarepta Therapeutics, Inc.


title:
A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase II Study to Evaluate Senaparib Maintenance in mCRPC Patients with Homologous Recombination Repair Gene Alterations after Docetaxel Treatment

 Étude multicentrique de phase II, randomisée, en double aveugle, contrôlée contre placebo évaluant un traitement d’entretien par senaparib après un traitement par docétaxel chez des patients atteints de CPRCm avec altérations des gènes impliqués dans la réparation par recombinaison homologue

lead_sponsor: IMPACT Therapeutics, Inc.


title: A Phase 3, open-label, single-arm, repeated-dose study to evaluate the  safety and tolerability, pharmacokinetics, and antiviral activity of  maribavir for the treatment of cytomegalovirus (CMV) infection in  children and adolescents who have received a hematopoietic stem cell  transplant (HSCT) or a solid organ transplant (SOT)

acronym: Protego

lead_sponsor: Takeda Development Center Americas, Inc.


title: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone (GNX) Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy (TrustTSC)

acronym: Adjunctive GNX Treatment Compared with Placebo in Children and Adults with TSC-related Epilepsy

lead_sponsor: Marinus Pharmaceuticals Inc.


title: Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant

lead_sponsor: AlloVir, Inc.


title: A Phase II Study of Pembrolizumab Monotherapy in Third-line Previously Treated Subjects with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus or Advanced/Metastatic Siewert Type I Adenocarcinoma of the Esophagogastric Junction (KEYNOTE -180)

acronym: Study of Pembrolizumab in Previously Treated Subjects with Advanced/Metastatic Adenocarcinoma

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: An Open-Label, Multicenter, Long-term Extension Study of Tislelizumab-Containing Treatment and/or Pamiparib-Containing Treatment in Patients With Advanced Malignancies

lead_sponsor: BeiGene, Ltd.


title: A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, with and without Intermittent LowDose Cyclophosphamide, in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE).

acronym: VITALIZE

lead_sponsor: IMV Inc.


title:
A Phase 2b, Open-label, Single-arm, Multi-centre Study Assessing the Efficacy and Safety of   Adavosertib as Treatment for Recurrent or Persistent Uterine Serous Carcinoma (ADAGIO)

 Étude multicentrique de phase 2b, ouverte, à un seul groupe, évaluant l’efficacité et la tolérance de l’adavosertib en traitement du carcinome séreux de l’utérus récidivant ou persistant (ADAGIO)

acronym: ADAGIO


title: IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH).

acronym: IMPAHCT

lead_sponsor: Aerovate Therapeutics, Inc.


title: INTERVENTIONAL, NON-BLINDED, RANDOMIZED CONTROLLED MULTICENTER STUDY OF POSACONAZOLE PROPHYLAXIS FOR THE PREVENTION OF INFLUENZA-ASSOCIATED ASPERGILLOSIS (IAA) IN CRITICALLY ILL PATIENTS

acronym: POSA-FLU

lead_sponsor: UZ Leuven


title: An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients with Chronic Kidney Disease

acronym: EAGLE

lead_sponsor: Reata Pharmaceuticals, Inc.


title:
A Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel
 Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
 (DESTINATION)

 Etude d’extension de phase III multicentrique, en double aveugle, randomisée, contrôlée contre placebo et en groupes parallèles, évaluant la sécurité d’emploi et la tolérance du Tezepelumab, chez des patients adultes et adolescents, présentant un asthme sévère non contrôlé (DESTINATION)

acronym: DESTINATION

lead_sponsor: AstraZeneca AB


title:
A Phase IIIb, open-label, hybrid type III trial evaluating implementation
 strategies for long-acting cabotegravir plus long-acting rilpivirine every two months in
 HIV-1 infected, virologically suppressed adults in select European healthcare settings.

acronym: CAB And RPV Implementation Study in European Locations

lead_sponsor: Viiv Healthcare UK Limited


title:
A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations, followed by an open label extension (OLE)

 Étude multicentrique, randomisée, en double aveugle, contrôlée contre placebo visant à évaluer l'enzastaurine dans la prévention des événements artériels chez des patients atteints de syndrome d'Ehlers-Danlos vasculaire (SEDv) confirmé par la détection de mutations du gène COL3A1, suivie d'une extension en ouvert (EO)

acronym: PREVEnt (Prevention of Rupture with Enzastaurin in Vascular Ehlers-Danlos Syndrome Trial)

lead_sponsor: Aytu BioPharma, Inc.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination with Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease

lead_sponsor: Equillium, Inc.


title:
Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON)

 Etude sur la désensibilisation de l’allergie à l’arachide par immunothérapie orale précoce (POSEIDON)

acronym: POSEIDON

lead_sponsor: Aimmune Therapeutics , Inc.


title:
A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study in Prurigo Nodularis with Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)

 Étude de phase IIb/III, randomisée, en double aveugle, contrôlée contre placebo, à 2 bras, visant à évaluer l’efficacité et l’innocuité de la nalbuphine en comprimés à libération prolongée dans le prurigo nodulaire pour le soulagement du prurit par modulation des lésions de grattage (étude PRISM - Pruritus Relief through Itch Scratch Modulation)

lead_sponsor: Trevi Therapeutics, Inc.


title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE NAÏVE TO ERYTHROPOIESIS-STIMULATING AGENTS

lead_sponsor: Akebia Therapeutics, Inc.


title: An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)

lead_sponsor: Cellectar Biosciences, Inc.


title:
Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

 Étude d'extension du Tazemetostat (TRuST) : une étude d'extension en ouvert

lead_sponsor: Epizyme, Inc.


title:
A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study with a 36–week Extension to Investigate the Use of Benralizumab for Patients with Moderate to Severe Atopic Dermatitis Despite Treatment with Topical Medications (The HILLIER Study)

 Étude de phase 2, internationale, randomisée, en double aveugle, en groupes parallèles, contrôlée par placebo, menée sur 16 semaines avec une période d’extension de 36 semaines, évaluant l’utilisation du benralizumab chez des patients atteints de dermatite atopique modérée à sévère et traités par des médicaments topiques (étude HILLIER)

acronym: HILLIER


title: SPIRonolactone In the Treatment of Heart Failure - A double-blind, randomized, placebo-controlled, parallel group, interventional phase III study to evaluate the efficacy and safety of spironolactone compared to placebo on the composite endpoint of recurrent heart failure hospitalizations and cardiovascular death in patients with heart failure with mid- range or preserved ejection fraction

lead_sponsor: Charité Universitätsmedizin Berlin