title: A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly)

acronym: A-CHOP-14 (elderly)

lead_sponsor: University Medicine Goettingen


title: Randomized, comparative, open label treatment with double-blind placebo-controlled periods within treatment study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY 79-4980 compared to once-a-week prophylaxis treatment and to on-demand treatment with rFVIII-FS reconstituted with water for injection in previously treated patients with severe hemophilia A

source: euctr

lead_sponsor: Bayer Healthcare LLC

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title: A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancer

acronym: RAPTOR

lead_sponsor: Novartis Pharma Services AG


title: MULTICENTRE, RANDOMIZED, DOUBLE BLIND WITHIN FREQUENCY OF ADMINISTRATION, PLACEBO CONTROLLED, DOSE-FINDING, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF 3 DOSES OF P-3058 NAIL LACQUER (5% o.d., 10% o.d., AND 10% o.w.) GIVEN FOR 52 WEEKS IN PATIENTS WITH ONYCHOMYCOSIS

lead_sponsor: Polichem SA


title: A 28-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study to assess AIN457 versus placebo in inducing and maintaining uveitis suppression in adults with active, non-infectious, intermediate, posterior or panuveitis requiring immunosuppression (INSURE Study)

acronym: INSURE

status: Prematurely Ended

status_simplified: Unknown


title: Multinational européan trial for children with the opsoclonus myoclonus syndrome/dancing eye syndrome.

acronym: OMS

lead_sponsor: INSTITUT CURIE

lead_sponsor_type: academique


title: A MULTI-NATIONAL, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO COMPARE THE SAFETY AND EFFICACY OF 200 mg PAR-101 TAKEN q12h WITH 125 mg VANCOMYCIN TAKEN q6h FOR TEN DAYS IN SUBJECTS WITH CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA

lead_sponsor: Optimer Pharmaceuticals, Inc.


title: A randomised, double-blind, placebo-controlled, parallel group, dose ranging study evaluating the efficacy and safety of GW642444M administered once daily compared with placebo for 28 days in adolescent and adult subjects with persistent asthma.

lead_sponsor: GlaxoSmithKline Research & Development


title: A RANDOMIZED, MULTICENTRE THERAPEUTIC CONFIRMATORY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PROXINIUM™ PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE IN PATIENTS WITH ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE RECEIVED AT LEAST ONE ANTI-CANCER TREATMENT REGIMEN FOR ADVANCED DISEASE

lead_sponsor: Viventia Biotech Inc.

status: Ongoing

status_simplified: Ongoing


title: A double-blind placebo controlled study of 1g, 2g and 4g V0251 efficacy and tolerance in vestibular neuritis.

lead_sponsor: PIERRE FABRE MEDICAMENT - IRPF


title: A randomized, open-label, controlled, mutli-center two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 µg with peg alpha-2a montherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive CHB


title: A randomized, open-label, active-controlled, multicenter, parallel group study to assess the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride (HCl) formulation versus 5% amorolfine nail lacquer for 48 weeks of treatment in patients with mild to moderate toenail onychomycosis


title: Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer’s Type

lead_sponsor: Myriad Pharmaceuticals, Inc


title: An open-label study investigating long-term safety and tolearability of Nasalfent (Fentanyl Citrate Nasal Spray) in the treatment of breakthrough cancer pain (BTCP) in subjects taking regular opioid therapy

lead_sponsor: Archimedes Development Ltd


title: Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naïve HIV-1 Infected Adult Subjects.

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy.

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A 26 week treatment, randomized, multi center, double blind, double dummy, parallel-group study to assess the safety of indacaterol (300 and 600 µg o.d.) in patients with moderate to severe persistent asthma, using salmeterol (50 µg b.i.d.) as an active control.


title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (sodium oxybate) in Subjects with Fibromyalgia

lead_sponsor: Jazz Pharmaceuticals, Inc.


title: Double-blind, randomised, placebo-controlled multicentre phase III clinical study followed by open-label phase on the efficacy and tolerability of budesonide 3 mg effervescent tablet in patients with resistant oral chronic GvHD

lead_sponsor: Dr. Falk Pharma GmbH


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia- Study A

acronym: Phase III Safety and Efficacy Study in Primary Insomnia Patients - Study A

lead_sponsor: Merck & Co., Inc.


title: A 52-Week Open-Label Extension and Safety Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood, P/266/2011, P/267/2011, P/268/2011

lead_sponsor: Kowa Research Europe, Ltd.


title: Study 200622: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of mepolizumab in the treatment of adolescent and adult subjects with severe hypereosinophilic syndrome


title: A RANDOMIZED, OPEN, MULTINATIONAL, MULTICENTRE, 2-PART STUDY IN SPONTANEOUSLY BREATHING PRETERM NEONATES WITH MILD TO MODERATE RESPIRATORY DISTRESS SYNDROME TO INVESTIGATE THE SAFETY, TOLERABILITY AND EFFICACY OF INHALED NEBULIZED PORACTANT ALFA (PORCINE SURFACTANT, CUROSURF®) IN COMPARISON WITH nCPAP ALONE

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: A Phase III, Multicenter, Double-Blind, Randmoized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

lead_sponsor: Laboratoires Merck Sharp & Dhome-Chibret


title: A twenty-six weeks, open-label extension trial to evaluate safety and efficacy of Org 50081 in outpatients with chronic primary insomnia who completed clinical trial protocol 21106.

acronym: Aquamarine

lead_sponsor: NV Organon


title: A 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the efficacy on blood glucose control and safety of five doses of LCQ908 (2, 5, 10, 15 and 20 mg) or sitagliptin 100 mg on a background therapy of metformin in obese patients with type 2 diabetes

lead_sponsor: Novartis Pharma Services AG


title: A facilitated access open-label, non-randomized, multicenter, long-term safety and efficacy study in Chronic Kidney Disease patients treated with SBR759 who have completed previous SBR759 studies

lead_sponsor: Novartis Pharma


title: The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis: A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial

lead_sponsor: Peptimmune Inc.


title: A Phase III randomized, double blind, placebo controlled, multicenter study of panobinostat for maintenance of response in patients with Hodgkin’s lymphoma who are at risk for relapse after high dose chemotherapy and autologous stem cell transplant


title: Open-label, single-arm, flexible dosing, Phase III trial, with oral tapentadol PR in subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF 5503/15 trial.

lead_sponsor: Grünenthal GmbH


title:
A Phase II Randomized Open Label Study of MM-121 in
 combination with Paclitaxel versus Paclitaxel alone in
 patient with Platinum Resistant/Refractory Advanced
 Ovarian Cancers.

lead_sponsor: MERRIMACK PHARMACEUTICALS


title: A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO)

lead_sponsor: Astellas Pharma Europe B.V.


title: A PHASE III RANDOMIZED TRIAL OF GEMCITABINE (NSC# 613327) PLUS DOCETAXEL (NSC# 628503) FOLLOWED BY DOXORUBICIN (NSC# 123127) V. OBSERVATION FOR UTERUS-LIMITED, HIGH GRADE UTERINE LEIOMYOSARCOMA

lead_sponsor: EORTC


title: A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects greater than 6 to less than 12 Years of Age

lead_sponsor: Janssen-Cilag International N.V.


title:
A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer Who have Failed Prior Treatment with a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)

 Etude de phase III randomisée en ouvert évaluant l’efficacité et la sécurité d’emploi de l’olaparib (LynparzaTM) en comparaison à l’enzalutamide ou l’acétate d’abiratérone chez les hommes atteints d’ un cancer de prostate métastatique résistant à la castration (CPRCm), en échec d’un traitement par un agent hormonal de nouvelle génération et porteurs d’une mutation des gènes impliqués dans la voie de réparation par recombinaison homologue (HRR) (PROfound)

acronym: PROfound

lead_sponsor: AstraZeneca


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial)

acronym: Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy  (ATTR-PN)

lead_sponsor: Eidos Therapeutics, Inc.


title: Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer

lead_sponsor: Sanofi-aventis recherche & développement


title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Studies

acronym: Follow-Up Study to Assess Long-Term Safety of Infants exposed to Retosiban

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: An open label, randomised, parallel group clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic subjects with poor control.

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 2 or 3. ACHIEVE-2/3

lead_sponsor: Human Genome Sciences, Inc.


title: Exploratory efficacy and safety, pharmacokinetics and dose-finding study of ATryn® (antithrombin alfa) in patients with disseminated intravascular coagulation associated with severe sepsis

lead_sponsor: LEO Pharma A/S


title: Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain. A multinational, multicenter, randomized, double blind, parallel groups, placebo-controlled study.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: Placebo-controlled trial on the efficacy of growth hormone replacement therapy in patients with growth hormone deficiency after traumatic brain injury

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


title: A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 1.  ACHIEVE -1


title:
Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV)

 Efficacité et tolérance de l’association Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) administrée 2 fois par jour en supplément d’un traitement par l’association Travoprost 0.004% / Timolol 0.5% (DUOTRAV).

acronym: Safety and Efficacy of Simbrinza as an Adjunctive to DuoTrav

lead_sponsor: Alcon Research Ltd


title:
A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium

 NiCCC (Nintedanib (BIBF1120) en comparaison à une chimiothérapie chez les patients en rechute d’un Carcinome à Cellules Claires de l’ovaire ou de l’endomètre)

acronym:
NiCCC Trial (BIBF1120)

 NICCC

lead_sponsor: Greater Glasgow Health Board


title: A MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION

lead_sponsor: ONO Pharmaceutical Co.,Ltd


title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.

lead_sponsor: Wyeth Pharmaceuticals France


title:
DORADO-EX – A Dose-Blinded, Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
 A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic

acronym: DORADO-EX

lead_sponsor: Gilead Sciences Inc.


title: A Randomised, Phase IIb Placebo-controlled Study of R-ICE Chemotherapy (Rituximab, Ifosfamide, Carboplatin, and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

lead_sponsor: Seattle Genetics, Inc.


title:
DORADO-AC-EX – A Double-Blind, Active-Controlled, Long-Term Safety Extension Study to the Phase 3 DORADO-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
 A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects with Resistant Hypertension Despite Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)

acronym: DORADO-AC-EX

lead_sponsor: Gilead Sciences, Inc.


title: PHASE 4, PROSPECTIVE, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED STUDY TO EVALUATE SMOKING CESSATION WITH VARENICLINE TARTRATE COMPARED WITH PLACEBO IN THE SETTING OF PATIENT SELF-SELECTED (FLEXIBLE) QUIT DATE

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


title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disorder

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Montherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease


title: Randomized phase II trial evaluating the feasibility and tolerance of the combination of FOLFOX with cetuximab and the combination of FOLFOX with cetuximab and bevacizumab as perioperative treatment in patients with resectable liver metastases from colorectal cancer.

acronym: BOS

lead_sponsor: European Organisation for Research and Treatment of Cancer


title: A multicenter, randomized, double blind, placebo controlled Phase III study to assess the efficacy of xaliproden in patients with oxaliplatin-induced peripheral sensory neuropathy (PSN) following adjuvant chemotherapy for colon cancer

acronym: XENON

lead_sponsor: sanofi-aventis groupe


title:
A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women with Early Stage Breast Cancer Not Overexpressing HER-2 and Estrogen Receptors.
 And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 1.0, Date 21-Dec-2006).

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Prospective, randomized, observer-blind, parallel-group, multi-center trial to assess efficacy and safety of two different dilutions of NT 201 in patients with upper limb spasticity

acronym: NT-SPIN

lead_sponsor: Merz Pharmaceuticals GmbH


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

lead_sponsor: sanofi-aventis recherche et développement


title: Post authorisation safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 recombinant human erythropoietin alfa i.v.

acronym: not applicable

lead_sponsor: Hexal Biotech ForschungsGmbH


title: A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Schizophrenia “ASPIRE EU” (Aripiprazole Intramuscular Depot Program in Schizophrenia)

acronym: ASPIRE EU

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.


title: Efficacy and safety of aclidinium bromide at two dose levels vs placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD)

lead_sponsor: Laboratorios Almirall, S.A.


title: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Previously Treated with Ruxolitinib

lead_sponsor: CTI BioPharma Corp.


title: Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

lead_sponsor: PFIZER


title: A   Phase III,  Randomised,  Double-blind,  Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)

lead_sponsor: Mitsubishi Pharma Corporation


title: A Phase III, Double-blind, Multi-centre, Randomised, Parallel Group Design, Placebo-controlled, Flexible Dose Study of MCI-196 in Combination with a Calcium-based Phosphate Binder in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia.


title: A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects with Genotype 1 Chronic Hepatitis C

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A PHASE 2, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, INTERNATIONAL, MULTICENTER STUDY OF ORAL TAC 101 AS SECOND LINE TREATMENT IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA WHO RECEIVED SORAFENIB AS FIRST LINE THERAPY

lead_sponsor: Taiho Pharma USA, Inc.


title: A PHASE 2, OPEN-LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN COMBINATION WITH CETUXIMAB IN PRETREATED SUBJECTS WITH KRAS MUTANT METASTATIC COLORECTAL CANCER

lead_sponsor: Celgene Corporation


title:
TPL108392:  An open-label, multi-centre rollover study to assess the safety and efficacy of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin)
 ENABLE-ALL (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C Related Liver DiseasE – All Subjects Withdrawing From ENABLE 1 and 2 through Lack of Response)

acronym: ENABLE ALL

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: SIOPEL 6: Essai thérapeutique international multicentrique randomisé de phase III: Effet du thiosulfate de sodium (STS) dans la réduction de la toxicité auditive chez des patients traités par cisplatine pour un hépatoblastome de risque standard

acronym: SIOPEL 6

lead_sponsor: Centre Hospitalier Universitaire de Besançon


title: An open label, comparative, randomised, balanced crossover trial comparing nasal fentanyl and oral transmucosal fentanyl (Actiq) in breakthrough pain in patients with cancer.

lead_sponsor: Nycomed Danmark ApS


title: A SIX MONTH, OPEN-LABEL OUTPATIENT, RANDOMIZED PARALLEL GROUP TRIAL ASSESSING THE IMPACT OF DRY POWDER INHALED INSULIN (EXUBERA®) ON GLYCEMIC CONTROL COMPARED TO INSULIN GLARGINE (LANTUS®) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE POORLY CONTROLLED ON A COMBINATION OF TWO OR MORE ORAL AGENTS

lead_sponsor: Pfizer Inc


title: A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine

lead_sponsor: AstraZeneca AB


title:
A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis.
 And Pharmacogenetics Blood sample Amendment - Site Specific

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)

lead_sponsor: Teva Pharmaceutical Industries, Ltd


title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Previously Treated with TNF Antagonist Therapy

acronym: CERTIFI

lead_sponsor: Centocor BV


title: A Multicenter, Randomized, Double-Masked, Parallel-Group Study Evaluating the Efficacy and Safety of Cyclosporine Ophthalmic Solution 0.010% Compared with its Vehicle Administered QID for 3 months Followed by a 9 Month Open-Label Phase in Patients with Atopic Keratoconjunctivitis.

lead_sponsor: Allergan Limited


title: A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN 144) for Treatment of Patients with Metastatic Melanoma

acronym: Study of LN-144 in the Treatment of Patients with Metastatic Melanoma

lead_sponsor: Iovance Biotherapeutics, Inc.


title: A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

lead_sponsor: Mundipharma Research GmbH & Co. KG


title: Randomized Phase II of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects with Triple Negative (ER, PR, Her2 negative) Locally Advanced non-resectable and/or Metastatic Breast Cancer

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA)

acronym: RESTART


title: A dose ranging,  randomized, double blind, parallel-group  placebo-controlled  multi-center study of  RO5313534 used as add-on to donepezil treatment in patients with mild to moderate symptoms of Alzheimer’s Disease

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-on Compared to Uptitration of Metformin in Patients with Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

acronym: Prompt


title: A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-of-Care Controlled, Feasibility and Safety Study of rhBMP-2/CPM as an Adjuvant Therapy for Fractures of the Proximal Femur

lead_sponsor: Wyeth Pharmaceuticals Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Explore the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients with Refractory Partial Seizures

lead_sponsor: Eisai Limited


title: A 12-week, double-blind, randomised, parallel group, multi-centre, study to evaluate efficacy and safety of budesonide/formoterol (Symbicort® Turbuhaler®) 320/9 µg one inhalation twice daily on top of tiotropium (Spiriva®) 18 µg one inhalation once daily compared with tiotropium 18 µg one inhalation once daily, in patients with severe chronic obstructive pulmonary disease (COPD)

acronym: CLIMB


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

lead_sponsor: Allergan Ltd


title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ORALLY ADMINISTERED PH-797804 (0.5, 3, 6 AND 10 MG) IN ADULTS WITH MODERATE TO SEVERE CHRONIC

lead_sponsor: Pfizer Ltd, Ramsgate Road, Sandwich, Kent


title: Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN (SATURN): A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease

acronym: SATURN


title: A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of MOVICOL® with Placebo in Patients with Constipation Associated with Irritable Bowel Syndrome (IBS)

lead_sponsor: Norgine Pharmaceuticals Ltd


title: A 48-week, multicentre, multinational, randomized, double-blind, 2-arm parallel group study, comparing the efficacy of FOSTER™ for maintenance and reliever versus fixed-dose FOSTER™ for maintenance + salbutamol as reliever in asthmatics ≥12 years of age

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: Impact of Tadalafil (LY450190) Once a Day or Tadalafil On Demand Compared to Sildenafil Citrate On Demand on Treatment Discontinuation in Patients with Erectile Dysfunction who are Naïve to PDE5 Inhibitors

lead_sponsor: Eli Lilly and Company Limited


title: A phase III study to compare SonoVue guided prostate biopsy with systematic biopsy in the detection of prostate malignant lesions in patients with suspected prostate cancer

acronym: SonoVue guided prostate biopsy

lead_sponsor: Bracco Imaging SPA


title: A MULTICENTER, OPEN, SINGLE SEQUENCE CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF A TACROLIMUS MODIFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN STABLE LIVER TRANSPLANT PATIENTS CONVERTED FROM A PROGRAF BASED IMMUNOSUPPRESSIVE REGIMEN

lead_sponsor: Astellas Pharma GmbH


title: A MULTICENTER, RANDOMIZED, OPEN-LABEL COMPARISON OF THE SAFETY AND EFFICACY OF TIGECYCLINE WITH THAT OF AMPICILLIN-SULBACTAM OR AMOXICILLIN-CLAVULANATE TO TREAT COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS.

lead_sponsor: Wyeth Pharmaceuticals, Inc.


title: PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo

lead_sponsor: Ferring Pharmaceuticals A/S


title: A Phase 3 Randomized, Double-Blind, Placebo- and Oxycodone-Controlled, Multicenter Study of the Efficacy and Safety of Tanezumab in Patients with Osteoarthritis of the Knee or Hip

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


title: A Randomised, Placebo-controlled, Double-blind, Multicentre Efficacy and Safety Study of LJPC-501 in Paediatric Patients > 2 to 17 Years of Age with Catecholamine-Resistant Hypotension Associated with Distributive Shock

lead_sponsor: La Jolla Pharmaceutical Company


title: A Phase 1b/2 study of AMG 655 Combination with Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

lead_sponsor: Amgen Inc


title: A 10-week randomised, double-blind, parallel-group, placebo-controlled phase 2 study to investigate the extent of symptom relief and the safety and tolerability of SMP-986 (20 mg, 40 mg, 80 mg and 120 mg) administered once daily for 8 weeks to patients with overactive bladder syndrome

acronym: SMP-986 phase 2 proof of concept in patients with OABS

lead_sponsor: Dainippon Sumitomo Pharma Europe Ltd.


title: A single-blind, placebo-controlled, multicentre study evaluating continued long-term treatment with satavaptan (SR121463B) in patients with ascites due to liver cirrhosis who have previously been treated in studies LTS5634 or LTS5635.

lead_sponsor: sanofi-aventis recherche et développement


title: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome

acronym: SICCANOVE

lead_sponsor: Novagali Pharma S.A.


title: A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over

lead_sponsor: Nippon Shinyaku Co., LTD


title: A Phase III, Multicentre, Randomised, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable CUV1647 Implants in Patients with Erythropoietic Protoporphyria (EPP)

acronym: Multicentre Phase III EPP Study

lead_sponsor: Clinuvel Pharmaceuticals Limited


title: A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis

lead_sponsor: Intercept Pharmaceuticals


title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib plus Best Supportive Care (BSC) versus Placebo plus BSC in Subjects with Advanced Hepatocellular Carcinoma (HCC) who have Failed or are Intolerant to Sorafenib: The BRISK Study

acronym: BRISK study

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease

lead_sponsor: Teva Pharmaceutical Industries Ltd.


title: CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients with Mild-to-Moderate Alzheimer’s Disease on Donepezil

acronym: CONCERT

lead_sponsor: Medivation, Inc.


title: Initiation of agomelatine after antidepressant treatment by SSRI or SNRI in outpatients suffering Major Depressive Disorder. A 3-week, randomised, double then single-blind, controlled, parallel groups, international, multicentre safety study with a 5-week open extension period.

lead_sponsor: Institut de Recherches Internationales Servier


title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

lead_sponsor: AstraZeneca AB


title: An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

lead_sponsor: Eli Lilly and Company


title: A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination with Cetuximab in Second-Line Cetuximab-Naïve Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

acronym: EMD 1201081 in Cetuximab-Naïve Subjects with R/M SCCHN

lead_sponsor: Merck KGaA


title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus

acronym: Celestial 47

lead_sponsor: Cephalon, Inc.


title: An open-label trial with TMC125 as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who participated in a DUET trial (TMC125-C206 or TMC125-C216).

lead_sponsor: Tibotec Pharmaceuticals Limited


title: A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects

acronym: Thrive


title: A Phase IIa, Double-blind, Randomised, Parallel-group, Multi-centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2423 Compared to Placebo in Patients with Posttraumatic Neuralgia


title: A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY REGIMENS IN SUBJECTS WITH PREVIOUSLY TREATED METASTATIC BREAST CANCER

lead_sponsor: Genentech Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study, to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

acronym: CANTATA-MSU Trial

lead_sponsor: Janssen-Cilag International NV


title: A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX-4 plus cetuximab versus UFOX plus cetuximab as first-line therapy in subjects with metastatic colorectal cancer

acronym: FUTURE


title: A Phase 1b/ 2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

lead_sponsor: Amgen Inc


title: A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer


title: The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

acronym: Geographic Atrophy Treatment Evaluation (GATE)

lead_sponsor: Alcon Research, Ltd


title: A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination with AMG 386 or Placebo in Subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma

lead_sponsor: Amgen Inc.


title: A Phase III Open-Label, Single-Group Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients

acronym: MICONOS EXTENSION

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Ltd


title: The Impact of LY2189265 versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)

acronym: GBDC

lead_sponsor: Eli Lilly & Company - Indianapolis


title:
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple-Negative Breast Cancer

 Étude de Phase III randomisée en double aveugle évaluant l’efficacité et la sécurité d’emploi du capivasertib + paclitaxel versus placebo + paclitaxel dans le traitement de première ligne de patients présentant un cancer du sein triple négatif confirmé histologiquement, localement avancé (inopérable) ou métastatique


title: A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination with Epacadostat (INCB024360) or Placebo in Participants with Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

acronym: Phase 3 Study of Pembro with/without Epacadostat in 1L Urothelial Carcinoma

lead_sponsor: Incyte Corporation


title:
Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to
 Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy
 in Subjects With Diffuse Cutaneous Systemic Sclerosis

acronym: TERGISS

lead_sponsor: medac GmbH


title: A multinational, randomized, double-blind placebo controlled study of AVE8062 (25 mg/m²) administered every 3 weeks in patients with advanced-stage soft tissue sarcoma, treated with cisplatin (75 mg/m²) after failure of anthracycline and ifosfamide chemotherapies.

lead_sponsor: sanofi-aventis recherche et développement


title: An Open-Label, Multicenter Study of the Effects of Remission Maintenance Therapy with Ceplene® (Histamine Dihydrochloride), Given in Conjunction with Low-Dose Interleukin-2 (IL-2, Proleukin), on Immune Response and Minimal Residual Disease (MRD) in Adult Patients with Acute Myeloid Leukemia (AML) in First Complete Remission (CR1)

lead_sponsor: EpiCept Corporation


title: A Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy


title: Study FDC114615: Comparative efficacy of DuodartTM plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naïve men with moderately symptomatic benign prostatic hyperplasia and prostate enlargement.

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: Efficacy and safety of the SQ tree SLIT-tablet in subjects with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch group

lead_sponsor: ALK Abello A/S


title: A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA

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


title: A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorectal Cancer


title: Interventional, open-label, flexible-dose extension study of aripiprazole once-monthly in patients with schizophrenia

lead_sponsor: H. Lundbeck A/S


title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy.

lead_sponsor: AstraZeneca AB


title: A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms

acronym: FIELD (Fabrazyme: Intervening Early at a Lower Dose)

lead_sponsor: Genzyme Europe BV


title: A PHASE 2B/3 OPEN-LABEL ROLLOVER STUDY FOR SUBJECTS DISCONTINUING FROM THE UK-453,061 PROTOCOLS FOR THE TREATMENT OF HIV-1 INFECTED SUBJECTS


title: A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

lead_sponsor: F Hoffmann-La Roche Ltd


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism.

lead_sponsor: Amgen Inc


title: A PHASE 2B MULTICENTER, RANDOMIZED, COMPARATIVE TRIAL OF UK-453,061 VERSUS ETRAVIRINE IN COMBINATION WITH DARUNAVIR/RITONAVIR AND A NUCLEOTIDE/NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED HIV-1 INFECTED SUBJECTS WITH EVIDENCE OF NNRTI RESISTANT HIV-1

lead_sponsor: Pfizer Inc


title: A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys® and Copegus® versus Pegasys® and Copegus® alone in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection

lead_sponsor: F.Hoffmann-La Roche


title:
A Randomized, Double-Blind, Multi-Center Phase 2 Trial of Exemestane (Aromasin®) plus Dasatinib versus Exemestane plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer after Disease Progression on a Non-steroidal Aromatase Inhibitor (NSAI).
 + Administrative Letter 1 dated 18-Aug-2008.

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Phase 2a/2b study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotypes 1 and 4 Chronic Hepatitis C Infection.

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor

acronym: Study comparing the Efficacy and Safety of Retosiban Versus Atosiban in Spontaneous Preterm labor

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A phase II randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection

lead_sponsor: Boehringer Ingelheim France


title: Cilengitide in subjects with newly diagnosed glioblastoma multiforme and unmethylated MGMT gene promoter - a multicenter, open-label Phase II study, investigating two cilengitide regimens in combination with standard treatment (temozolomide with concomitant radiation therapy, followed by temozolomide maintenance therapy) - CORE.

acronym: CORE

lead_sponsor: Merck KGaA


title: ICON7 - A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer.

acronym: ICON7 GCIG Trial (International Collaborative Ovarian Neoplasm 7)

lead_sponsor: Medical Research Council


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis and Previously Treated with Biologic Anti-TNFα Agent(s)

lead_sponsor: Centocor B.V.


title: A PHASE 2, RANDOMIZED, DOSE-RANGING STUDY TO ASSESS THE SAFETY AND ANTI-CYTOMEGALOVIRUS (CMV) ACTIVITY OF MARIBAVIR VERSUS VALGANCICLOVIR FOR TREATMENT OF CMV INFECTIONS IN TRANSPLANT RECIPIENTS WHO DO NOT HAVE CMV ORGAN DISEASE

lead_sponsor: VIROPHARMA INCORPORATED


title: A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1-to-11-Year-Old Pediatric Subjects with Endoscopically Proven GERD

lead_sponsor: Janssen-Cilag International NV


title: Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic Syndrome

lead_sponsor: DAIICHI SANKYO EUROPE GmbH


title: Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx®, Doxil®) for Women (age 66 years or older) with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a “Standard Chemotherapy Regimen”

acronym: Chemotherapy Adjuvant Study for women at advanced Age (CASA)

lead_sponsor: International Breast Cancer Study Group (IBCSG)


title: Effect of LY450139, a γ-Secretase Inhibitor, on the Progression of Alzheimer’s Disease as Compared with Placebo

lead_sponsor: Eli Lilly and Company


title: Prospective randomised phase II trial of oral vinorelbine and cisplatin or pemetrexed and cisplatin in first line Metastatic or Locally Advanced Non-Small-Cell Lung Cancer patients with non-squamous histological type.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A Phase 2, Randomized Study of VELCADE® (bortezomib), Dexamethasone, and Thalidomide Versus VELCADE® (bortezomib), Dexamethasone, Thalidomide, and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma Who are Candidates for Autologous Transplantation.

lead_sponsor: Janssen-Cilag International, N.V.Turnhoutseweg 30, 2340 Beerse, Belgium


title: A Randomised, Multicentre, Open Label, Phase II study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib with Capecitabine for the Treatment of Metastatic Breast Cancer.

lead_sponsor: GlaxoSmithKline research & Development


title: A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)

lead_sponsor: Nippon Shinyaku Co., Ltd.


title: A randomized, multicentre, open-label, Phase II study of the efficacy and safety of lapatinib plus epirubicin and cyclophosphamide (EC90-L) followed by weekly paclitaxel and lapatinib (PX-L) compared with EC90 followed by weekly paclitaxel and trastuzumab (PX-T), as neoadjuvant therapy in patients with previously untreated ErbB2-overexpressing Stage I - IIIA invasive breast cancer with primary tumour size > 1cm.

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Phase 2B, randomized, blinded, dose-ranging, active-controlled, parallel-group, multi-center study to evaluate the dose response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who switch from recombinant human erythropoietin.


title: A Phase III, randomised, double blind, placebo controlled study to evaluate the safety and efficacy of subcutaneous implants of CUV1647 in patients suffering from polymorphic light eruption (PLE).

acronym: Phase III Trial of CUV1647 in PLE

lead_sponsor: Clinuvel Pharmaceuticals Limited


title: A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT

acronym: Midex

lead_sponsor: Orion Corporation Orion Pharma


title: Open-Label Extension for Alzheimer’s Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)


title: Phase II study of PHA-739358 administered by a 24-hour IV infusion every 14 days in advanced/metastatic breast, ovarian, colorectal, pancreatic, small cell lung and non small cell lung cancers.

acronym: not available

lead_sponsor: Nerviano Medical Sciences S.r.l.


primary_purpose: Treatment

acronym: CENTAUR

intervention_type: Drug

title: CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis

lead_sponsor: Tobira Therapeutics, Inc.

study_completion_date_type: Actual

type: EudraCT Number

design_allocation: Randomized

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Qian T, Fujiwara N, Koneru B, Ono A, Kubota N, Jajoriya AK, Tung MG, Crouchet E, Song WM, Marquez CA, Panda G, Hoshida A, Raman I, Li QZ, Lewis C, Yopp A, Rich NE, Singal AG, Nakagawa S, Goossens N, Higashi T, Koh AP, Bian CB, Hoshida H, Tabrizian P, Gunasekaran G, Florman S, Schwarz ME, Hiotis SP, Nakahara T, Aikata H, Murakami E, Beppu T, Baba H, Rew Warren, Bhatia S, Kobayashi M, Kumada H, Fobar AJ, Parikh ND, Marrero JA, Rwema SH, Nair V, Patel M, Kim-Schulze S, Corey K, O'Leary JG, Klintmalm GB, Thomas DL, Dibas M, Rodriguez G, Zhang B, Friedman SL, Baumert TF, Fuchs BC, Chayama K, Zhu S, Chung RT, Hoshida Y. Molecular Signature Predictive of Long-Term Liver Fibrosis Progression to Inform Antifibrotic Drug Development. Gastroenterology. 2022 Apr;162(4):1210-1225. doi: 10.1053/j.gastro.2021.12.250. Epub 2021 Dec 22. Erratum in: Gastroenterology. 2022 Aug;163(2):536.

ReferenceCitation: Nielsen MJ, Leeming DJ, Goodman Z, Friedman S, Frederiksen P, Rasmussen DGK, Vig P, Seyedkazemi S, Fischer L, Torstenson R, Karsdal MA, Lefebvre E, Sanyal AJ, Ratziu V. Comparison of ADAPT, FIB-4 and APRI as non-invasive predictors of liver fibrosis and NASH within the CENTAUR screening population. J Hepatol. 2021 Dec;75(6):1292-1300. doi: 10.1016/j.jhep.2021.08.016. Epub 2021 Aug 27.

ReferenceCitation: Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22.

ReferenceCitation: Ratziu V, Sanyal A, Harrison SA, Wong VW, Francque S, Goodman Z, Aithal GP, Kowdley KV, Seyedkazemi S, Fischer L, Loomba R, Abdelmalek MF, Tacke F. Cenicriviroc Treatment for Adults With Nonalcoholic Steatohepatitis and Fibrosis: Final Analysis of the Phase 2b CENTAUR Study. Hepatology. 2020 Sep;72(3):892-905. doi: 10.1002/hep.31108. Epub 2020 Jul 21.

ReferenceCitation: Lefebvre E, Moyle G, Reshef R, Richman LP, Thompson M, Hong F, Chou HL, Hashiguchi T, Plato C, Poulin D, Richards T, Yoneyama H, Jenkins H, Wolfgang G, Friedman SL. Antifibrotic Effects of the Dual CCR2/CCR5 Antagonist Cenicriviroc in Animal Models of Liver and Kidney Fibrosis. PLoS One. 2016 Jun 27;11(6):e0158156. doi: 10.1371/journal.pone.0158156. eCollection 2016.

ReferenceCitation: Friedman S, Sanyal A, Goodman Z, Lefebvre E, Gottwald M, Fischer L, Ratziu V. Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design. Contemp Clin Trials. 2016 Mar;47:356-65. doi: 10.1016/j.cct.2016.02.012. Epub 2016 Mar 2.

enrollment_type: Actual

location_country:
Poland
Hong Kong
Spain
Italy
United Kingdom
Australia
United States
France
Belgium
Germany

summary: The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.


title:
DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
 A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo

acronym: DORADO-AC

lead_sponsor: Gilead Sciences, Inc.


title: A MULTI-CENTER, LONG TERM, OPEN-LABEL STUDY OF [S,S]-REBOXETINE (PNU-165442G) ADMINISTERED ONCE DAILY IN PATIENTS WITH FIBROMYALGIA

lead_sponsor: Pfizer Inc.,


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Efficacy of a Single Treatment of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Injected into the Prostate for the Treatment of Lower Urinary Tract Symptoms in Patients due to Benign Prostatic Hyperplasia

lead_sponsor: Allergan Inc.


title: A two-arm, randomised, double-blind, placebo-controlled, multicenter phase II study to evaluate safety and tolerability and to explore the neuroprotective effect of atacicept as assessed by Optical Coherence Tomography (OCT) in subjects with Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) over a 36 week treatment course

acronym: Atacicept in Optic Neuritis, Phase II

lead_sponsor: Merck Serono International S.A.


title: A prospective randomized, open-labelled, multi-centre trial comparing the safety and efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to that of Prezista® (Darunavir, DRV/r) in  three-class (NRTI, NNRTI, and PI) treatment-experienced patients with resistance to more than one PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

acronym: POTENT

lead_sponsor: Boehringer Ingelheim France SAS


title: A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies

lead_sponsor: H. Lundbeck A/S


title: A Multicenter, Open-Label, Randomized Study Comparing the Efficacy and Safety of  S-1 as a Single Agent at 30 mg/m2 BID versus 5-FU Bolus Infusion for the Treatment of Patients with Metastatic Pancreatic Cancer Previously Treated with a Gemcitabine Based-Regimen

acronym: S-1 Pancreas

lead_sponsor: sanofi-aventis recherche & developpement


title: Efficacy and safety of 2mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a 12-week, multi-center, randomized, double-blind, placebo-controlled study

acronym: SAMS 12 (Sleep And Metabolism Study, 12 weeks)

lead_sponsor: sanofi-aventis recherche & développement


title: A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients who are Ineligible to Receive Cisplatin-Based Therapy

acronym: VINCENT

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric coated mycophenolate sodium (Myfortic) in combination with two corticosteroid regimens for the treatment of lupus nephritis flare

acronym: Mylupus

lead_sponsor: Novartis Pharma Services AG


title: A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.

lead_sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium


title:
Prospective Trial for the diagnosis and treatment of
 children, adolescents and young adults with Intracranial Germ Cell Tumours

 essai prospectif pour le diagnostic et le traitement des enfants, adolescents et jeunes adultes porteurs d’une tumeur germinale intracrânienne

acronym: SIOP CNS GCT II

lead_sponsor: Universitätsklinikum Münster


title:
A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

 Une étude pivot, en double aveugle, randomisée, contrôlée par placebo, multinationale du SGX942 (Dusquetide) pour le traitement de la mucite buccale chez des patients recevant une chimioradiothérapie concomitante pour traiter le carcinome à cellules squameuses de la tête et du cou

lead_sponsor: Soligenix UK Limited


title: Phase 2 Single-Arm Open-Label Extension Study to Investigate Safety with Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study 1311.5

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

lead_sponsor: Janssen Cilag international NV


title: An open label follow-up trial of the efficacy and safety of chronic administration of the combination of telmisartan 40mg + amlodipine 5mg or the combination of telmisartan 80mg + amlodipine 5mg tablets alone or in combination with other antihypertensive medications in patients with hypertension.


title: A prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids

lead_sponsor: AB Science

status: Prohibited by CA


title: A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19 associated acute respiratory failure in patients aged ≥ 65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE study).

lead_sponsor: ABIVAX


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

lead_sponsor: Eisai Limited


title:
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia

 Etude randomisée de phase III visant à comparer le trioxyde d’arsenic (ATO) combiné à de l’ATRA et de l’Idarubicine contre un traitement standard de l’ATRA et de la polychimiothérapie à base d’antracyclines (schéma AIDA) chez les patients avec une leucémie aiguë promyélocytaire de haut risque nouvellement diagnostiquée – Etude APOLLO

acronym:
APOLLO

 APOLLO

lead_sponsor: Technische Universität Dresden


title: A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene (AURA3)

lead_sponsor: AstraZeneca AB


title:
A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia

 Étude de Phase 3b, multicentrique, en ouvert, à un bras, évaluant l’acalabrutinib (ACP-196) chez des patients présentant une leucémie lymphoïde chronique


title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

lead_sponsor: Incyte Corporation


title:
Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steatohepatitis (NASH).

 Étude multicentrique, en ouvert, évaluant la sécurité et la tolérance de doses croissantes d’HepaStem chez des patients atteints de stéatohépatite non-alcoolique (également appelé NASH) à un stade de cirrhose ou de pré-cirrhose.

lead_sponsor: Promethera Biosciences


title: PACIFICA Phase 3: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)

acronym: PACIFICA

lead_sponsor: CTI BioPharma Corp.


title: A multicenter, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis

acronym: not availabe

lead_sponsor: BioTech Tools S.A.


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

lead_sponsor: GB002, Inc.


title:
An open-label, non-randomized, within-patient dose-finding study followed by a randomized, subject, investigator and sponsor-blinded placebo controlled study to assess the efficacy and safety of CDZ173 (Leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/ p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

 Etude en ouvert, non randomisée, de détermination de la dose intra patient, suivie par une étude randomisée, en aveugle pour les patients, les médecins-investigateurs et Novartis, contrôlée par placebo, évaluant l’efficacité et la sécurité d’emploi de CDZ173 (leniolisib) chez des patients atteints d’APDS/PASLI (Syndrome de PI3K-delta activée/Déficit immunitaire, lymphadénopathie et cellules T sénescentes dus à des mutations activatrices de p110-delta)

acronym: Study of efficacy of CDZ173 in patients with APDS/PASLI


title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

lead_sponsor: Takeda Development Center Americas, Inc.


title: ENGOT-EN1/FANDANGO: A randomized phase II trial of first-line combination chemotherapy with nintedanib / placebo for patients with advanced or recurrent endometrial cancer.

lead_sponsor: Nordic Society of Gynaecological Oncology (NSGO)


title: A phase I/II, multicenter, open-label study of EGFRmut–TKI EGF816,administered orally in adult patients with EGFRmut solid malignancies

lead_sponsor: Novartis Pharma AG


title: An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)

lead_sponsor: Albireo AB


title: A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma

acronym: Phase III trial of pembrolizumab or brentuximab vedotin in Hodgkin lymphoma

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


title:
A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids.

 Etude de phase IIa comparant la tolérance et l’efficacité d’ABX464 administré à la dose quotidienne de 50 mg à un placebo chez des sujets présentant une rectocolite hémorragique active modérée à sévère résistants ou intolérants aux traitements immunomodulateurs, aux Anti-TNFα, au vedolizumab et/ou aux corticoïdes.

acronym:
Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.

 Etude de tolérance et d’efficacité de l’ABX464 chez des patients atteints de colite ulcéreuse active


title: A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS CABOZANTINIB ALONE IN PATIENTS WITH INOPERABLE, LOCALLY ADVANCED, OR METASTATIC RENAL CELL CARCINOMA WHO EXPERIENCED RADIOGRAPHIC TUMOR PROGRESSION DURING OR AFTER IMMUNE CHECKPOINT INHIBITOR TREATMENT

lead_sponsor: F. Hoffman-La Roche Ltd.


title: A double-blind, randomised, placebo-controlled, multicentre, relapse-prevention study with two doses of Lu AA21004 in patients with Major Depressive Disorder.

acronym: Not applicable

lead_sponsor: H. Lundbeck A/S


title: A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TRK-750 in Colorectal Cancer Patients with Chemotherapy-induced Peripheral Neuropathy Following Oxaliplatin-containing Chemotherapy in the Adjuvant Setting

lead_sponsor: Toray Industries, Inc.


title: A randomised, double-blind, parallel-group, placebo-controlled and active-referenced study evaluating the efficacy and safety of three fixed dose regimens of Lu AA34893 in the treatment of Major Depressive Disorder.


title: A multicenter, randomized, double blind (double dummy), active-comparator controlled study to compare the efficacy, safety and tolerability of taspoglutide versus pioglitazone in type 2 diabetes patients inadequately controlled with sulfonylurea (SU) monotherapy or metformin plus sulfonylurea combination therapy.

acronym: EMERGE 6

lead_sponsor: F. Hoffmann-La Roche Ltd


title: An international, randomised, double blinded, multi-centre, active- and placebo-controlled dose response trial to evaluate the efficacy and safety of SABER-Bupivacaine for postoperative pain control in patients following arthroscopic shoulder surgery

lead_sponsor: Nycomed Danmark ApS


title: A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, FIRST LINE MAINTENANCE STUDY OF LENALIDOMIDE (REVLIMID®) IN PATIENTS WITH MANTLE-CELL LYMPHOMA

acronym: The RENEW trial

lead_sponsor: Celgene Corporation


title: MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical study A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis

acronym: MUSIC

lead_sponsor: Actelion Pharmaceuticals Ltd.


title: EFFICACY AND SAFETY OF ERAXIS™/ECALTA® (ANIDULAFUNGIN) COMPARED TO CANCIDAS® (CASPOFUNGIN) IN NEUTROPENIC PATIENTSWITH INVASIVE CANDIDA INFECTION

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


title:
A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO)

 Étude multicentrique, randomisée, en double aveugle, contrôlée contre placebo, en groupes parallèles visant à évaluer l'efficacité, la tolérance et la sécurité d’une perfusion sous-cutanée continue de ND0612 administrée comme traitement complémentaire à la lévodopa orale chez des patients atteints de la maladie de Parkinson avec fluctuations motrices (iNDiGO)

acronym: iNDiGO

lead_sponsor: NeuroDerm Ltd.


title: Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma

acronym: RTOG

lead_sponsor: EORTC


title:
Open-label, dose-escalating trial to evaluate the tolerability, toxicity, safety, pharmacokinetics, pharmacodynamics and activity of volasertib added to the standard intensive salvage chemotherapy regimen with liposomal daunorubicine, fludarabine and cytarabine (DNX-FLA) followed by fludarabine and cytarabine (FLA) in children from 3 months to less than 18 years of age with acute myeloid leukaemia after failure of the front-line therapy

 Etude en ouvert, en escalade de dose, visant à évaluer la tolérabilité, la toxicité, la tolérance, la pharmacocinétique, la pharmacodynamie et l’activité du volasertib administré en plus d’une chimiothérapie de rattrapage associant daunorubicine liposomale, fludarabine et cytarabine (DNX-FLA) suivie de l’association fludarabine et cytarabine (FLA) chez des enfants de 3 mois à moins de 18 ans ayant une leucémie myéloïde aiguë après échec d’une chimiothérapie de première ligne.

lead_sponsor: BOEHRINGER INGELHEIM


title: A randomized, double-blind, placebo controlled, multi-centre, phase IIA study to assess the effect on GERD symptoms, pharmacokinetics, safety and tolerability of four weeks treatment with AZD3355 65 mg bid as add-on treatment to a PPI  in patients with an incomplete response to PPI treatment

lead_sponsor: AstraZeneca AB


title: A phase II, multicentre study of oral LBH589 in patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

lead_sponsor: Novartis Pharma Services AG


title: A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors


title: Open label study of bevacizumab maintenance therapy (AVASTIN) with or without pemetrexed after a first line treatment chemotherapy with bevacizumab-cisplatin-pemetrexed in patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)


title: A Phase II, Double-Blind, Placebo Controlled, Multi-Centre, Randomised Study of AZD0530 in Patients with Advanced Ovarian Cancer Sensitive to Platinum-Based Chemotherapy


title:
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled
 Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.

acronym: RELAX-AHF

lead_sponsor: Corthera, Inc.


title: A 52-Week, International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study with a 52-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin compared with Sulphonylurea in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone


title:
A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1≥ 50%

 Etude de phase II, randomisée, en ouvert, multicentrique, évaluant l’efficacité et l’innocuité du capmatinib (INC280) associé au pembrolizumab versus pembrolizumab en première ligne chez des patients ayant un cancer bronchique non à petites cellules localement avancé ou métastatique, avec surexpression de PD-L1 ≥ 50 %

lead_sponsor: Novartis Pharma AG


title: Randomized, double-blind, placebo and comparator-controlled, parallel-group, multi-center trial assessing the effects of BF2.649 in the treatment of excessive daytime sleepiness in narcolepsy

acronym: Harmony I bis

lead_sponsor: Bioprojet


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia.

acronym: A Study in Benign Prostatic Hyperplasia

lead_sponsor: Eli Lilly and Company


title: A Randomized Phase 3 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Alone or with Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients with Metastatic Non-Small Cell Lung Cancer

acronym: Phase 3 Study of Pembrolizumab/Epacadostat/Chemotherapy in Metastatic NSCLC

lead_sponsor: Incyte Corporation


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-003 Administered Intrathecally in Patients With Huntington’s Disease

lead_sponsor: Wave Life Sciences UK Limited


title:
A randomized, double blind, placebo-controlled, multi-center, parallel group study to evaluate the efficacy and safety of dupilumab in patients with prurigo nodularis who are inadequately controlled on topical prescription therapies or when those therapies are not advisable

 Étude randomisée, en double aveugle, contrôlée par placebo, multicentrique, en groupes parallèles, visant à évaluer l’efficacité et la sécurité d’emploi du dupilumab chez des patients atteints de prurigo nodulaire qui sont insuffisamment contrôlés par des traitements topiques prescrits ou lorsque ces traitements ne sont pas conseillés

acronym: LIBERTY-PN PRIME2

lead_sponsor: Sanofi-aventis Recherche & Développement


title: A multicenter, double-blind, placebo-controlled, randomised, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease

lead_sponsor: AB Science


title: A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis – The Connection study

acronym: The Connection study

lead_sponsor: Infant Bacterial Therapeutics AB (IBT)


title: KPL-716-C201: A Phase 2a/b, Randomized, Double-Blind, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis

lead_sponsor: Kiniksa Pharmaceuticals, Ltd.


title: A PHASE II STUDY EXPLORING THE SAFETY AND EFFICACY OF ATEZOLIZUMAB ADMINISTERED IN COMBINATION WITH OBINUTUZUMAB OR RITUXIMAB ANTI-CD20 THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA, MARGINAL ZONE LYMPHOMA AND WALDENSTRÖM MACROGLOBULINEMIA

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A multicenter, open-label, randomized, active-controlled, parallel group, pivotal study to investigate the efficacy, safety and tolerability, and pharmacokinetics of murepavadin combined with one anti-pseudomonal antibiotic versus two anti-pseudomonal antibiotics in adult subjects with ventilator-associated bacterial pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa.

lead_sponsor: Polyphor Ltd.


title: A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension

acronym: TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide

lead_sponsor: ACTELION Pharmaceuticals Ltd


title:
A Phase 1/2, Open-label, Multicenter, Non-randomized Study to  Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Pediatric Patients from Birth to Less than 1 Year of Age with X-linked Hypophosphatemia (XLH)

 Étude de phase 1/2, en ouvert, multicentrique, non randomisée visant à évaluer la sécurité d’emploi, la tolérance, la  pharmacocinétique et l’efficacité  du burosumab chez des patients pédiatriques depuis la naissance jusqu’à l’âge d’un an et atteints d’hypophosphatémie  liée à l’X (XLH)

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd.


title: A multi-centre randomized, placebo-controlled trial of mirabegron, a new beta3-adrenergic receptor agonist on the progression of left ventricular mass and diastolic function in patients with structural heart disease.

lead_sponsor: Université catholique de Louvain (UCL)


title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)

lead_sponsor: MorphoSys AG


title: A Well-Controlled, Fixed-Dose Study of TEV 50717 (Deutetrabenazine) for the Treatment of Tics Associated with Tourette Syndrome

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.


title: PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF)

acronym: PRESTIGE-AF

lead_sponsor: Imperial College of Science, Technology and Medicine


title:
PROLONGSTEM: HepaStem Long-Term Safety Registry Registry for patients who have been administered HepaStem

 PROLONGSTEM : Registre sur la sécurité à long terme d’HepaStem Registre pour les patients qui ont été perfusés avec HepaStem

lead_sponsor: Promethera Biosciences


title: Phase III confirmatory efficacy and safety trial of remimazolam (CNS7056) compared with propofol for intravenous anaesthesia during elective surgery

lead_sponsor: PAION UK Limited


title:
Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity

 Essai thérapeutique de phase 2 portant sur la setmélanotide (RM-493) chez des patients atteints de maladies génétiques rares de l’obésité

acronym: Basket Study

lead_sponsor: Rhythm Pharmaceuticals, Inc.


title:
A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (cannabinol) Cream in Patients with Epidermolysis Bullosa.

 Étude de phase II, randomisée, en double aveugle et contre crème véhicule portant sur l’INM-755 (cannabinol) par voie topique chez des patients atteints d’épidermolyse bulleuse

lead_sponsor: InMed Pharmaceuticals Inc.


title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS


title: A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib plus Best Supportive Care (BSC) compared to Placebo plus BSC in Patients with Advanced or Metastatic Gastric Cancer (GC)

lead_sponsor: LSK BioPartners, Inc


title: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy

lead_sponsor: Incyte Corporation


title: A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.

lead_sponsor: Instituto Grifols, S.A


title: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema with Normal C1-Inhibitor (C1-INH)

lead_sponsor: Takeda Development Center Americas (TDCA)


title: A multicenter, multinational, randomized, double-blind, placebo-controlled study to assess the efficacy, pharmacodynamics, pharmacokinetics, safety, and tolerability of venglustat in late-onset GM2 gangliosidosis (Tay-Sachs disease and Sandhoff disease) together with a separate basket for juvenile/adolescent late-onset GM2 gangliosidosis and ultra-rare diseases within the same and similar glucosylceramide-based sphingolipid pathway

acronym: AMETHIST

lead_sponsor: Genzyme Corporation


title: PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

acronym: PiSARRO

lead_sponsor: Aprea AB


title: Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

acronym: Assessment of safety & antitumor activity of GSK3377794 in NY-ESO-1+ and/or LAGE-1a+ solid tumors

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A phase IIb, prospective, multicentre, double-blind, triple-arm, randomized versus placebo trial, to assess the efficacy of a single injection of either 2 or 10 x 106 autologous adipose derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis (OA) of the knee, active and unresponsive to conservative therapy for at least 12 months.

acronym:
ADIPOA 2

 ADIPOA 2

lead_sponsor: CHU Montpellier


title:
A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who Received 4 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

 Etude de phase IIIB/IV d’optimisation de la fréquence de la dose, évaluant le Nivolumab 240 mg toutes les deux semaines versus le Nivolumab 480 mg toutes les 4 semaines chez les patients atteints d’un cancer bronchique non à petites cellules avancé ou métastatique ayant reçu un traitement par le Nivolumab à une dose de 3 mg/kg ou 240 mg toutes les deux semaines pendant 4 mois

acronym: CheckMate 384: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 384

lead_sponsor: Bristol-Myers Squibb International Corporation


title:
An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304.

 Etude d‘extension (roll-over), multicentrique, en ouvert, évaluant la sécurité d’emploi à long terme d’évérolimus chez les patients atteints de sclérose tubéreuse de Bourneville présentant des crises d’épilepsie pharmacorésistantes et continuant à tirer bénéfice du traitement selon l’investigateur après avoir terminé l'étude CRAD001M2304

lead_sponsor: Novartis Pharma AG


title:
A 52-week, randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilic phenotype

 Étude multicentrique de 52 semaines, randomisée, en double aveugle, contrôlée par placebo, à groupes parallèles, de l’efficacité et de la sécurité d’emploi du traitement adjuvant par GSK3511294 chez des patients adultes et adolescents atteints d’asthme sévère non contrôlé avec un phénotype éosinophilique.

lead_sponsor: GlaxoSmithKline Research & Development Limited


title:
An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

 Étude ouverte, randomisée, contrôlée par médicament actif, multicentrique, de phase 3, pour évaluer la sécurité et l'efficacité du danaparoïde par rapport à l'argatroban dans le traitement de sujets atteints d'une TIH aiguë (étude HITSOVA)

acronym:
HITSOVA

 HITSOVA

lead_sponsor: Aspen Global Incorporated


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib

lead_sponsor: Kartos Therapeutics, Inc.


title: A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in combination with Gemcitabine Plus Nab-paclitaxel as Neoadjuvant Treatment in Patients with Locally Advanced, Unresectable Pancreatic Cancer

acronym: Not available

lead_sponsor: FibroGen, Inc.


title:
A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants with Moderately to Severely Active Ulcerative Colitis

 Étude de phase 3, randomisée, en double aveugle, à bras parallèles, contrôlée par placebo et traitement de référence, portant sur le mirikizumab et le védolizumab chez des participants atteints de rectocolite hémorragique active modérée à sévère

acronym: LUCENT-ACT

lead_sponsor: Eli Lilly and Company


title: A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease

acronym: The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease)

lead_sponsor: Acucela Inc.


title: A phase 2 randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study of the safety and efficacy of I-0401 in the treatment of patients with fractures of the tibial plateau requiring grafting.

lead_sponsor: Kuros Biosurgery AG


title: A randomised, double-blind, placebo-controlled, multi-national Phase II/III study of the safety and efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adult patients suffering from house dust mite allergic rhinitis

lead_sponsor: Stallergenes S.A


title: Cetrorelix pamoate (AEZS-102) in patients with symptomatic BPH: a double-blind placebo-controlled efficacy study

lead_sponsor: Aeterna Zentaris GmbH


title: Efficacy and safety of ASF 1057 cream 0.5% in the treatment of seborrhoeic dermatitis: A phase III randomised, double-blind, vehicle-  and placebo controlled, parallel groups, multi-centre trial.

lead_sponsor: Astion Pharma A/S


title: Efficacy and Safety of AP  12009 in Adult Patients with Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) as Compared to Standard Treatment with Temozolomide or BCNU: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.

acronym: SAPPHIRE

lead_sponsor: Antisense Pharma GmbH


title: A controlled open label randomised parallel group study to evaluate the efficacy, safety, and tolerability of subcutaneous MIRCERA, versus no ESA therapy, in the treatment of anaemia in CKD patients after kidney transplant.

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Randomized, Double-blinded, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination with Pegasys® and Copegus® versus the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection.


title: A randomised, double-blind, placebo-controlled, multi-national, Phase III trial to assess the efficacy and safety of 300 IR sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adolescents and children above the age of 5 years, suffering from house dust mite allergic rhinitis

lead_sponsor: Stallergenes S.A.


title: A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s Lymphoma

lead_sponsor: Mundipharma Research Limited


title:
A PHASE 4, BLOOD SAMPLE COLLECTION STUDY FOR EXPLORATORY EVALUATION OF THE ASSOCIATION OF SINGLE NUCLEOTIDE
 POLYMORPHISMS WITH TREATMENT RESPONSES FROM SUBJECTS WITH HBEANTIGEN POSITIVE OR NEGATIVE CHRONIC HEPATITIS B, WHO RECEIVED THERAPY FOR HEPATITIS B WITH PEGINTERFERON ALFA-2A 40KD (PEG-IFN) ± NUCLEOS(T)IDE ANALOGUE

lead_sponsor: F.Hoffmann-La Roche Ltd.


title: A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in Combination with Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients

acronym: Zalutumumab in Combination with Chemo-Radiation in NSCLC

lead_sponsor: Genmab A/S


title: A Phase 1/2 trial on the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of DYN101 in patients ≥ 16 years of age with centronuclear myopathies caused by mutations in DNM2 or MTM1

acronym: Research Using an Investigational Treatment for CNM (Unite-CNM)

lead_sponsor: Dynacure SAS


title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF CD5024 1% CREAM TREATMENT FOR UP TO 52 WEEKS  IN SUBJECTS  WITH  PAPULOPUSTULAR ROSACEA

lead_sponsor: GALDERMA R&D SNC


title: A Long-term Follow-up Study of Subjects With β-thalassemia or Sickle Cell Disease Treated with Autologous CRISPR-Cas9 Modified Hematopoietic Stem Cells (CTX001)

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A Phase 3 Study of Pembrolizumab in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

acronym: Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in 1L ES SCLC

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


title:
An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease. The Late Presenter Treatment Optimisation Study (LAPTOP).

 Étude en ouvert, multicentrique, randomisée, visant à étudier le traitement antirétroviral par inhibiteur de l’intégrase, par rapport au traitement antirétroviral par inhibiteur de la protéase boosté, chez des patients atteints du VIH de stade avancé. Etude d’optimisation du traitement des patients dépistés tardivement (LAPTOP : The Late Presenter Treatment Optimisation Study)

acronym:
LAPTOP - Late Presenter Treatment Optimisation Study

 LAPTOP - Etude d’optimisation du traitement des patients dépistés tardivement

lead_sponsor: NEAT ID Foundation


title:
Long Term Extension Trial of setmelanotide (RM-493) for patients who have completed a trial of Setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

 Essai d'extension à long terme portant sur la setmélanotide (RM-493) chez des patients ayant terminé un essai utilisant la setmélanotide dans le traitement de l'obésité liée à des défauts génétiques en amont du récepteur aux mélanocortines de type 4 (MC4R) dans la voie leptine-mélanocortine

lead_sponsor: Rhythm Pharmaceuticals, Inc.


title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas

lead_sponsor: Astex Pharmaceuticals, Inc.


title:
Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)

 Étude de phase III, ouverte, multicentrique, évaluant le tabélecleucel chez des patients ayant reçu une transplantation d’organe solide ou de cellules souches hématopoïétiques allogéniques, atteints d’une lymphoprolifération post-transplantation liée au virus Epstein-Barr, après échec d'un traitement par rituximab ou rituximab et chimiothérapie (étude ALLELE)

acronym: ALLELE study

lead_sponsor: Atara Biotherapeutics, Inc.


title: A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome)

acronym: PATIDEGIB Phase 3 OLE study in subjects with Gorlin syndrome

lead_sponsor: PellePharm, Inc.


title:
Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical trial.

 Efficacité de l'association de la simvastatine et de la rifaximine chez les patients présentant une cirrhose décompensée pour prévenir la survenue de défaillances d’organes (ACLF pour acute on chronic liver failure): un essai clinique randomisé, multicentrique, en double aveugle, contrôlé contre placebo

lead_sponsor: IDIBAPS


title:
A Phase II Randomised, Multi-Centre Study to Investigate the Efficacy and Tolerability of a Second Maintenance Treatment in Patients with Platinum-Sensitive Relapsed Epithelial Ovarian Cancer, who have Previously Received PARP Inhibitor Maintenance Treatment

 Étude de phase II, multicentrique, randomisée, destinée à évaluer l’efficacité et la tolérance d’un deuxième traitement d’entretien chez des patientes présentant un cancer épithélial de l’ovaire en rechute platine-sensible, ayant reçu préalablement un premier traitement d’entretien par inhibiteur de PARP

lead_sponsor: AstraZeneca AB


title: A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)

lead_sponsor: Mirati Therapeutics, Inc.


title: A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

lead_sponsor: Applied Molecular Transport Inc.


title: A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

lead_sponsor: Apellis Pharmaceuticals, Inc.


title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

 Etude multicentrique de phase IIa en double aveugle, randomisée, contrôlée contre placebo et en groupes parallèles, évaluant l’efficacité et la sécurité d’emploi du Tezepelumab, chez des patients présentant une bronchopneumopathie chronique obstructive (BPCO) modérée à très sévère (COURSE)

acronym: COURSE


title: A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib with Lomustine to the Efficacy of Lomustine Alone

acronym: REGAL

lead_sponsor: ASTRAZENECA


title: A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years with Functional Constipation

lead_sponsor: Sucampo Pharma Europe Ltd.


title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Coadministered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus  Infection and Cirrhosis

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title:
A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection versus Intravenous Caspofungin Followed by Optional Oral Fluconazole Step-down in the Treatment of Subjects with Candidemia and/or Invasive Candidiasis (The ReSTORE Study)

 Étude de phase 3, multicentrique, randomisée, en double aveugle évaluant l'efficacité et la sécurité des injections de Rezafungine par rapport à la Caspofungine administrée en intraveineux avec un relai possible par Fluconazole par voie orale dans le traitement des patients atteints de candidémie et/ou de candidose invasive (étude ReSTORE)

lead_sponsor: Cidara Therapeutics Inc.


title:
A Randomized, Double-blind, Placebo-Controlled, Active Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

 Étude randomisée, en double aveugle, contrôlée par placebo, avec comparateur actif, multicentrique, de phase 3 portant sur le brentuximab védotine ou un placebo en association avec du lénalidomide et du rituximab chez des patients atteints d’un lymphome diffus à grandes cellules B (LDGCB) en rechute ou réfractaire

lead_sponsor: Seattle Genetics, Inc.


title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Adeno-associated Virus Serotype 8-mediated Gene Transfer of Glucose-6-phosphatase in Patients With Glycogen Storage Disease Type Ia.

 EMA Decision number on PIP: EMA/PDCO/154270/2021

lead_sponsor: Ultragenyx Pharmaceutical Inc.


title:
A phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adolescent subjects (12–17 years of age) with moderate-to-severe plaque psoriasis

 Essai de phase III, multicentrique, randomisé, en double aveugle, visant à évaluer l’efficacité, la sécurité et la tolérance du traitement par brodalumab par rapport au placebo (en aveugle) et à l’ustékinumab (en ouvert) chez des adolescents (âgés de 12 à 17 ans) atteints de psoriasis en plaques modéré à sévère

acronym: EMBRACE 1

lead_sponsor: LEO Pharma A/S