title: A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse.

lead_sponsor: AB Science


title: First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1029 in patients with malignant solid tumors

acronym: GEN1029 Safety Trial in Patients With Malignant Solid Tumors

source: euctr

lead_sponsor: Genmab B.V.

study_type: Interventional

status: Ongoing

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease

lead_sponsor: Forma Therapeutics, Inc.

status_simplified: Unknown


title:
A Randomised, Open label, Multicentre, Phase 3 Trial of First line Treatment with Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects with Steroid refractory Acute Graft versus host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

 Étude de phase III randomisée, multicentrique, en ouvert portant sur le traitement de première intention par cellules stromales mésenchymateuses MC0518 par rapport au meilleur traitement disponible chez des patients adultes ou adolescents présentant la forme aiguë de la maladie du greffon contre l'hôte réfractaire aux stéroïdes, suite à une greffe de cellules souches hématopoïétiques allogéniques (étude IDUNN)

acronym: IDUNN

lead_sponsor: medac Gesellschaft für klinische Spezialpräparate mbH


title:
Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks

 Essai de phase III randomisé, en double aveugle et contrôlé contre placebo, du béloranib chez les patients obèses présentant le syndrome de Prader-Willi, visant à évaluer le comportement alimentaire, le poids corporel total et l’innocuité pendant 52 semaines

acronym: bestPWS|EU

lead_sponsor: Zafgen Inc.

status: Prematurely Ended


title:
Open label, Multicenter, Prospective Study to Characterize the Pharmacokinetics and Pharmacodynamics of Cufence (Trientine Dihydrochloride) and to Investigate the Efficacy and Safety in Wilson’s Disease Patients

 Essai prospectif multicentrique en ouvert pour caractériser la pharmacocinétique et la pharmacodynamique de Cufence (dichlorhydrate de trientine) et d’en étudier l’efficacité et l’innocuité chez les patients atteints de la maladie de Wilson

acronym: TR-004 UNITED Study

lead_sponsor: Univar Solutions, B.V.


title: A Phase 2, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet

lead_sponsor: TAKEDA


title: A randomized, double blind, placebo controlled, multicenter study to determine the effect of QVA149 on mean 24-hours heart rate in patients with Chronic Obstructive Pulmonary Disease (COPD)

lead_sponsor: Novartis Pharma AG

status: Completed

status_simplified: Completed


title: Phase II Study of Combination Bortezomib, Dexamethasone, and Rituximab in previously untreated Patients with Waldenstrom’s Macroglobulinemia: A multicenter Trial of the European Myeloma Network

acronym: protocole BDR

lead_sponsor: Centre Hospitalier de Lens

lead_sponsor_type: academique


title: A Single-Arm Study to Provide Boceprevir Treatment in Subjects with Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin in Previous Schering-Plough Boceprevir Studies.

lead_sponsor: Schering-Plough Research Institute, A Division of Schering Corporation


title: EFFICACY AND TOLERABILITY OF CHONDROITIN SULPHATE 1000MG, TWICE DAILY IN PATIENTS WITH SYMPTOMATIC KNEE OSTEOARTHRITIS

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate efficacy and safety of masitinib in combination with etoposide, or masitinib in combination with irinotecan in patients with advanced hepatocellular carcinoma and who relapsed after a first line therapy with sorafenib.


title: A MULTICENTER, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF SUBCUTANEOUS AND/OR INTRAVENOUS PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA

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


title: An adaptive Phase 2/3, randomized, open-label study assessing efficacy and safety of hydroxychloroquine for hospitalized patients with moderate to severe COVID-19

lead_sponsor: sanofi-aventis recherche & développement


title: A Multicenter, Double-Blind, Active-Controlled, Parallel Group Study to Examine the Safety, Tolerability and Efficacy of Oral MK-0974 for the Long Term Treatment of Acute Migraine With or Without Aura

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: Proof of Concept study of the efficacy and tolerability of a 4-week treatment with F13640 in patients in whom the adaptation of opioid therapy of cancer pain has failed. A prospective, multinational, multicentre, randomised, double-blind, placebo-controlled study.


title: LONG-TERM MANAGEMENT OF ATOPIC DERMATITIS WITH THE EMOLLIENT V0034 CR.  A RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUPS,  DOUBLE-BLIND STUDY IN INFANTS AND CHILDREN

acronym: Not applicable


title: A Multicenter, Double-blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

lead_sponsor: Theratechnologies Inc.


title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with Alendronate

acronym: Odanacatib Study in Patients Previously Treated with Alendronate

lead_sponsor: Merck & Co. Inc


title: An adaptive dose-ranging, multi-center, single-blind, double-dummy, active-controlled trial to determine the target dose of canakinumab (ACZ885) in the treatment of acute flares in gout patients who are refractory or contraindicated to NSAIDs and/or colchicine

lead_sponsor: Novartis Pharma Services AG


title: An Investigator-initiated study on rFVIIa prophylaxis in children with haemophilia A and inhibitors

acronym: ENJOIH 01

lead_sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico


title: A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without Aura

lead_sponsor: Laboratoires Merck Sharp & Dohme-Chibret


title: A Randomized Discontinuation Phase II Trial of Deforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients with KRAS Mutations

lead_sponsor: Merck & Co. Inc.


title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of CUV1647 for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients

acronym: Phase II AK Study

lead_sponsor: Clinuvel Pharmaceuticals Limited


title: Safety of SCH 527123 in Subjects with Neutrophilic Asthma

lead_sponsor: Schering-Plough Research Institute, a Division of Schering Corporation


title: A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years

acronym: DPM-CF-204 mannitol in CF aged 6-17 years

lead_sponsor: Pharmaxis Ltd.


title: An international multicentre, randomized, parallel group, double-blind trial to evaluate different dose combinations of lercanidipine and enalapril in comparison with each component administered alone and with placebo in patients with essential hypertension.

lead_sponsor: Recordati S.p.A.,


title: Open-label, non-controlled, multicenter long-term study to investigate the safety and efficacy of Xeomin® (incobotulinumtoxin A, NT 201) for the treatment of spasticity of the lower limb(s) or of combined spasticity of upper and lower limb in children and adolescents (age 2 - 17 years) with cerebral palsy

lead_sponsor: Merz Pharmaceuticals GmbH


title: A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and the pharmacokinetics of GSK221149A administered orally in healthy, pregnant females, with uncomplicated pre-term labor between 30 0/7 – 35 6/7 weeks gestation.

lead_sponsor: GlaxoSmithKline Research and Development


title: A 28 week extension to a 24 week multi-center, randomized, double-blind clinical trial to evaluate the safety and tolerability of vildagliptin (50 mg qd) versus placebo in patients with type 2 diabetes and moderate or severe renal insufficiency

lead_sponsor: Novartis Services AG


title: An open-label safety study of S-888711 in adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy

lead_sponsor: Shionogi USA, Inc.


title: CLINICAL EFFICACY AND SAFETY OF TAZAROTENE CREAM 0.05% IN THE INITIAL AND MAINTENANCE THERAPIES OF LAMELLAR ICHTHYOSIS (LI)

lead_sponsor: Orfagen


title: A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of the Combination Regimen of MK-3682B (Grazoprevir/Ruzasvir/Uprifosbuvir) in Participants with Chronic Hepatitis C Virus Genotype 3 Infection

acronym: MK-3682B in Hepatitis C Virus (HCV) Genotype 3 (GT3) participants

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


title:
Additive Effect of Twice Daily Brinzolamide 1% /Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue

 Effet additif d'une administration deux fois par jour d'une association fixe de brinzolamide 1%/brimonidine 0.2% associé à un traitement par un analogue de la prostaglandine.

acronym: Simbrinza BID as an Adjunctive to Prostaglandin Analogue (PGA)

lead_sponsor: Alcon Research, Ltd.


title:
International, multicentre, efficacy and safety study of I10E in the
 maintenance treatment of patients with Chronic Inflammatory
 Demyelinating Polyradiculoneuropathy: Extension of PRISM study
 I10E-1302

acronym: PRISM 2

lead_sponsor: LFB BIOTECHNOLOGIES


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

lead_sponsor: Salix Pharmaceuticals, Inc.


title:
An International, Multicenter, Open-label, Long Term Extension Study Evaluating the Safety of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS)

 Étude internationale d'extension à long terme, multicentrique, en ouvert, évaluant l’innocuité de la pommade à la diacéréine 1 % en application locale chez les patients atteints d’épidermolyse bulleuse simple (EBS)

lead_sponsor: Castle Creek Pharmaceuticals, LLC


title: AN OPEN-LABEL, MULTICENTER, MULTIPLE-DOSE PHARMACOKINETIC AND 48-WEEK SAFETY AND EFFICACY TRIAL OF MARAVIROC IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY FOR THE TREATMENT OF ANTIRETROVIRAL-EXPERIENCED CCR5-TROPIC HIV-1 INFECTED CHILDREN 2-18 YEARS OF AGE

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


title: V0251 oral suspension efficacy and tolerance in vestibular neuritis. A randomised double-blind placebo controlled study

lead_sponsor: PIERRE FABRE MEDICAMENT -IRPF- PIERRE FABRE INNOVATION


title: A multi-center, randomized, double-blind clinical trial to evaluate the safety and tolerability of 24 weeks treatment with vildagliptin (50 mg qd or 100 mg qd) versus placebo in patients with type 2 diabetes and moderate renal insufficiency

lead_sponsor: Novartis Pharma Services AG


title: Immune Response to Influenza Vaccine in Subjects with B-cell Malignancies Treated with Idelalisib

lead_sponsor: Gilead Sciences, Inc.


title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP)

lead_sponsor: Isis Pharmaceuticals, Inc


title: MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study.

lead_sponsor: Mirum Pharmaceuticals Inc.


title: RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND EFFICACY STUDY  OF THE EMOLLIENT V0034CR IN ADDITION TO A MODERATELY POTENT CORTICOSTEROID IN THE ACUTE PHASE OF TREATMENT OF ATOPIC DERMATITIS IN INFANTS.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control.

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A phase III, randomized, double-blind, active-controlled, equivalence clinical trial to investigate the efficacy and safety of a single injection of 100 µg Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation (COS) using daily recombinant FSH (recFSH) as a reference

acronym: Ensure

lead_sponsor: NV Organon


title: A 52-week, multi-center, randomized, double-blind, placebo-controlled, parallel group study in patients with mild Alzheimer’s Disease (AD) to investigate the safety and tolerability of repeated subcutaneous injections of CAD106.

acronym: Not applicable.


title: FONDAparinux in patients with a plaster CAST (FONDACAST):  A Multicentre, Randomized, Open-label, Controlled, Two-Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Fondaparinux versus Low-molecular-Weight Heparin (Nadroparin), in Patients Requiring Rigid or Semi-rigid Immobilization for at least 21 Days and up to 45 Days because of Isolated Non-surgical Below-Knee Injury

acronym: FONDACAST

lead_sponsor: GlaxoSmithKline R & D


title: A phase 2B, randomised, double-blind, placebo-controlled, parallel group, dose-ranging, multicentre study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 for the prevention of migraine

lead_sponsor: Addex Pharma SA


title: A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

lead_sponsor: GlaxoSmithKline Research & Development Limited


title:
Thyroid hormone analog therapy of patients with severe psychomotor retardation caused by mutations in the MCT8 thyroid hormone transporter: The Triac Trial.

 Behandeling met een schildklierhormoon analoog bij patiënten met psychomotore retardatie veroorzaakt door een mutatie in de MCT8 schildklierhormoon transporter: de Triac Trial.

acronym:
Triac Trial in MCT8 patients

 Triac Trial in MCT8 patiënten.

lead_sponsor: Centre Hospitalier de Toulouse


title: A Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study of Patient Reported Outcomes in Friedreich’s Ataxia Patients after withdrawal from Treatment with Idebenone (PROTI Study)

acronym: PROTI

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


title: A randomised, double-blind, placebo-controlled, long-term Phase III study to assess the efficacy and safety of Oralgen® Grass Pollen in patients with grass pollen-related allergic rhinoconjunctivitis.

lead_sponsor: Artu Biologicals Europe B.V.


title: A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy


title: OLMESARTAN +AMLOIPINE TREATMENT IN DIABETIC PATIENTS: EVALUATING BLOOD PRESSURE CONTROL AFTER 48 HOURS FROM THE LAST ADMINISTRATION (MISSED DOSE)

lead_sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG SA


title:
Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII

 Etude clinique chez des enfants atteints d’hémophilie A sévère et préalablement traités visant à étudier l'immunogénicité, la tolérance et l'efficacité à long terme de Human-cl rhFVIII

lead_sponsor: Octapharma AG


title: Randomised phase II trial of oral vinorelbine and cisplatin followed by maintenance with single agent oral vinorelbine versus gemcitabine and cisplatin followed by maintenance with single agent gemcitabine in first line Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological type

lead_sponsor: Pierre Fabre Medicament


title: A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

lead_sponsor: Salix Pharmaceuticals, Inc.


title:
A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII at a dose of 4E13 vg/kg in Hemophilia A Patients with Residual FVIII Levels ≤ 1 IU/dL Receiving Prophylactic FVIII Infusions

 Étude de phase 3 ouverte, à un seul bras, destinée à évaluer l’efficacité et la sécurité du BMN-270, un vecteur viral adéno-associé pour le transfert de gène du facteur VIII humain à une dose de 4E13 vg/kg chez des patients atteints d’hémophilie A ayant des taux de base de FVIII ≤ 1 UI/dl et recevant des injections de FVIII en prophylaxie

lead_sponsor: BioMarin Pharmaceutical Inc.


title: Phase II study for repeated dosing of the trifunctional bispecific  anti-HER-2/neu x anti-CD3 antibody ertumaxomab in patients with  HER-2/neu 1+ or 2+/FISH negative expressing advanced or metastatic  breast cancer (stage IIIb/IV) progressing after endocrine treatment

lead_sponsor: Fresenius Biotech GmbH


title:
A Phase I Trial of NECTAR (Nelarabine, Etoposide and Cyclophosphamide in T-ALL Relapse): A Joint Study of TACL, POETIC and ITCC

 Essai de phase I NECTAR (Nélarabine, Etoposide et Cyclophosphamide dans les rechutes de LAL-T) : Une étude conjointe de TACL, POETIC et ITCC

acronym:
NECTAR trial

 Etude NECTAR

lead_sponsor: TACL


title: A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy.

acronym: GETAID 2014-3 SPARE

lead_sponsor: GETAID


title: Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of CUDC-907 With and Without Rituximab in Patients With Relapsed/Refractory MYC-Altered Diffuse Large B-Cell Lymphoma

lead_sponsor: Curis, Inc.


title: Treatment of steroid refractory gastro-intestinal acute graft-versus-Host disEase afteR AllogeneiC hematopoietic stem celL transplantation with fEcal microbiota transfer (HERACLES)

acronym: HERACLES

lead_sponsor: MaaT Pharma


title: An open label extension study to investigate the safety of cannabidiol (GWP42003-P; CBD) in children and adults with inadequately controlled Dravet or Lennox-Gastaut Syndromes

lead_sponsor: GW Research Ltd


title: Reduced dose-density of denosumab for maintenance therapy of unresectable giant cell tumor of bone: a multicenter phase II study "REDUCE"

lead_sponsor: European Organisation for Research and Treatment of Cancer (EORTC)


title: A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma

lead_sponsor: Epizyme, Inc.


title:
Phase III randomized clinical trial for stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

 Etude de phase 3 randomisée multicentrique et internationale comparant la chirurgie de cytoréduction première avec ou sans chimiohyperthermie intrapéritonéale dans les cancers épithéliaux de l’ovaire de stade III

acronym:
OVHIPEC-2

 OVHIPEC-2

lead_sponsor: Institut du Cancer de Montpellier


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN (SRA-333) SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE

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


title: A PHASE IIIB, RANDOMIZED, ACTIVE CONTROLLED OPEN-LABEL STUDY OF SUNITINIB (SUTENT) 37.5 MG DAILY VS IMATINIB MESYLATE 800 MG DAILY IN THE TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMORS (GIST) WHO HAVE HAD PROGRESSIVE DISEASE WHILE ON 400 MG DAILY OF IMATINIB

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


title: A Phase IIb, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study, Evaluating the Safety, Tolerability and Efficacy of RO4607381 by Measuring Flow Mediated Dilatation in the Brachial Artery, 24 hour Ambulatory Blood Pressure, Lipids, Lipoproteins and Markers Vascular Inflammation, Oxidation and CV risk in Patients with Coronary Heart Disease (CHD) or CHD Risk Equivalents

lead_sponsor: F.Hoffmann-La Roche Ltd.


title: Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Donepezil Hydrochloride in Preadolescent and Adolescent Children with Attention Impairment Following Cancer Treatment

lead_sponsor: Eisai Limited


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men with Both Erectile Dysfunction and Benign Prostatic Hyperplasia.

acronym: LVHR

lead_sponsor: Eli Lilly and Company


title: Efficacy and Safety comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Lymecycline 300mg Capsules versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules in the Treatment of  Moderate to Severe Acne Vulgaris.

acronym: TEAM - Tetralysal Epiduo = Acne Makeover

lead_sponsor: Galderma Research & Development


title: A randomised, open label, parallel-group, multi-centre trial to compare the efficacy and safety of TachoSil versus standard haemostatic treatment in the cardiovascular surgery

acronym: TachoSil versus standard haemostatis treatment of haemorrhage in cardiovascular surgery

lead_sponsor: Nycomed Danmark ApS


title: A PHASE II, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID®) IN SUBJECTS WITH RELAPSED OR REFRACTORY AGGRESSIVE NON-HODGKIN’S LYMPHOMA

lead_sponsor: Celgene Corporation


title: Multicenter parallel phase II trial of BI 2536 administered as one hour i.v. infusion every 3 weeks in defined cohorts of patients with various solid tumours. A new drug screening program of the EORTC Network of Core Institutions (NOCI)

acronym: Phase II trial of BI 2536 in pts with various solid tumors

lead_sponsor: Boehringer Ingelheim France SAS


title: Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction with Radioiodine for the Treatment of Multinodular Goiter

lead_sponsor: Genzyme Europe BV


title: An 18-week, International, Multi-centre, Randomized, Parallel-group, Double-Blind, Active-Controlled Phase IIIb Study to Evaluate the Efficacy and Safety of Saxagliptin in combination with Metformin in Comparison with Sitagliptin in combination with Metformin in Adult Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy alone

lead_sponsor: AstraZeneca AB


title: CONNECTION: A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients with Mild-to-Moderate Alzheimer’s Disease

acronym: CONNECTION

lead_sponsor: Medivation, Inc.


title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of Carisbamate in the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy Followed by a Blinded Extension Phase

lead_sponsor: Janssen Cilag International NV


title: Evaluation of the effect of 6 months treatment with V0191 on symptoms changes in patients with Mild Cognitive Impairment. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.

lead_sponsor: PIERRE FABRE MEDICAMENT - IDPF


title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures.

acronym: ELEVATE

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Subjects Previously Treated With Rituximab

lead_sponsor: Janssen-Cilag International NV


title: A Randomized, Double-Blind, Placebo Controlled, Multiple Dose Phase 2 Study to Determine the Safety and Efficacy of AMG 853 in Subjects with Inadequately Controlled Asthma

lead_sponsor: Amgen Inc


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY, COMPARING THE EFFICACY AND TOLERABILITY OF ZIPRASIDONE (ZELDOX®, GEODON®) VS OLANZAPINE (ZYPREXA®) IN THE TREATMENT AND MAINTENANCE OF RESPONSE IN PATIENTS WITH ACUTE MANIA

acronym: ZOOM STUDY: ZIPRASIDONE AND OLANZAPINE’S OUTCOMES IN MANIA

lead_sponsor: Pfizer Ltd - Sandwich Laboratories


title: Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks.

lead_sponsor: Institut de Recherches Internationales Servier


title: An open label, single-arm, baseline-controlled, multicenter study to evaluate the efficacy, safety and immunogenicity of subcutaneous HX575 administered once a week (qw) and once every two weeks (q2w) in the treatment of anemia associated with chronic kidney disease in pre-dialysis and dialysis subjects

acronym: SWEEP Study

lead_sponsor: Hexal AG


title: A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFα Inhibitor Therapy

acronym: BCDG


title: A randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 8-week treatment, multi-center trial evaluating the dose effect relationship for efficacy and the safety of 3 oral doses of surinabant: 2.5, 5 and 10mg/day as an aid to smoking cessation in cigarette smokers

acronym: SURSMOKE

lead_sponsor: sanofi-aventis recherche et développement


title: A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy

lead_sponsor: F. Hoffmann-La Roche Ltd


title: 13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease

lead_sponsor: Novartis Pharma AG


title: LENS – Long-term Eltrombopag ObservatioNal Study - A long term observational ocular safety study in adults who have received study medication (SB-497115-GR / eltrombopag olamine or placebo) in a phase II or III clinical study evaluating eltrombopag

acronym: LENS


title: Effect of inhalation of a free combination of tiotropium once daily 18 mcg and salmeterol twice daily 50 mcg versus a fixed combination of fluticasone and salmeterol twice daily (500/50 mcg) on static lung volumes and exercise tolerance in COPD patients (a randomized, double-blind, double dummy, 16 (2 x 8) weeks, crossover study)

acronym: Octane

lead_sponsor: Boehringer Ingelheim


title: Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas

lead_sponsor: Eli Lilly and Company Limited


title: A placebo controlled randomized, 12-week, dose-ranging, double-blind study versus placebo using tolterodine as a study calibrator, to evaluate efficacy and safety of SSR240600C in women with overactive bladder including urge urinary incontinence

lead_sponsor: sanofi-aventis recherche & développement


title: Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder.  An 8-week randomised, double-blind, fixed dose, international multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period of 16 weeks.


title: A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial

acronym: REGARD-PGx

lead_sponsor: Merck Serono S.A. - Geneva


title: A 24 month extension to a 12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic® after 3 months), vs. myfortic® plus tacrolimus in de novo renal transplant recipients

lead_sponsor: Novartis Pharma Services AG


title: A Phase II, Randomized, Double-Blinded, Multicenter, Dose Finding Study Evaluating the Efficacy and Safety of the HCV Polymerase Inhibitor Prodrug (RO4588161) when given 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 Virus infection

lead_sponsor: F.  Hoffmann-La Roche Ltd


title: A Phase III double blind, randomised, placebo-controlled study of the efficacy, safety and tolerability of idebenone in the treatment of Friedreich's Ataxia patients.

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


title: Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder. A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months.


title: A Randomised, Open-Label Preliminary Study To Assess The Effects Of Etanercept 50 mg Once Weekly For 24 Weeks And Etanercept 50 mg Twice Weekly For 12 weeks Reducing To Etanercept 50 mg Once Weekly For 12 weeks On Nail And Skin Symptoms In Patients With Nail Psoriasis And Plaque Psoriasis.

lead_sponsor: Wyeth Pharmaceuticals France


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LONG-TERM EXTENSION STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY LONG TERM EFFICACY OF LECOZOTAN (SRA-333) SR IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE TREATED WITH A CHOLINESTERASE INHIBITOR

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


title: A PARALLEL-GROUP, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER DOSE RESPONSE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF- 00885706, A 5-HT4 RECEPTOR PARTIAL AGONIST, AS ADD-ON THERAPY TO ESOMEPRAZOLE FOR THE RELIEF OF SYMPTOMS IN SUBJECTS WITH GASTRO-ESOPHAGEAL REFLUX DISEASE (GERD) WHO HAVE A POOR RESPONSE TO PROTON PUMP INHIBITOR (PPI) TREATMENT

lead_sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK


title: A 12-week treatment, multi-center, randomized, double-blind, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 µg o.d.) in patients with chronic obstructive pulmonary disease.


title: Randomized, controlled, double-blind multicenter safety study to evaluate the safety and immunogenicity of subcutaneous EPO HEXAL vs. ERYPO® in the treatment of anemia associated with chronic renal insufficiency in predialysis patients

lead_sponsor: HEXAL Biotech ForschungsGmbH


title: Efficacy evaluation of DOTAREM®-enhanced MRA compared to GADOVIST®–enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases

lead_sponsor: GUERBET


title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FILIBUVIR PLUS PEGYLATED INTERFERON ALFA-2A AND RIBAVIRIN IN TREATMENT NAÏVE, HCV GENOTYPE 1 INFECTED SUBJECTS

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


title:
A randomized  Discontinuation Study of Brivanib alaninate (BMS-582664) versus Placebo in Subjects with Advanced Tumors.
 Revised protocol 01 incorporating Amendment 02

lead_sponsor: Bristol Myers Squibb International Corporation


title: Randomized, Phase 2 Study of FOLFOX or FOLFIRI with AG-013736 or Bevacizumab in Patients with Metastatic Colorectal Cancer after Failure of an Irinotecan or Oxaliplatin-containing First-line Regimen

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


title: A Phase 3b,randomized,double-blind,placebo-controlled parallel-design study to evaluate the efficacy and safety of tadalafil coadministered with finasteride for  6 months in men with lower urinary tract symptoms(LUTS) and prostatic enlargement secondary to benign prostatic hyperplasia(BPH)

acronym: LVIW


title: A Multicentre, Randomised, Double Blind, Placebo controlled Phase IIb Study to compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of CytoFab™ (AZD9773) in Adult Patients With Severe Sepsis and/or Septic Shock

lead_sponsor: AstraZeneca AB


title: An open label, multinational, multicenter study to evaluate the safety of HX575 recombinant human erythropoietin alfa

lead_sponsor: Hexal AG


title: A Single Arm Multicentre Phase II Study of Panitumumab in Combination with Irinotecan/5-Fluorouracil/Leucovorin in Patients with Metastatic Colorectal Cancer

lead_sponsor: Amgen Inc


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Intraprostatic Administration of BOTOX® 200 U (Botulinum  Toxin Type A) Purified Neurotoxin Complex to Treat Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia

lead_sponsor: Allergan Limited


title: Effect of Passive Immunization on the Progression of Alzheimer’s Disease:  LY2062430 versus Placebo

lead_sponsor: Eli Lilly and Company


title: A phase III study of Pomalidomide and low dose Dexamethasone with or without Pembrolizumab (MK3475) in refractory or relapsed and refractory Multiple Myeloma (rrMM) (KEYNOTE 183)

acronym: A phase III study of Pomalidomide and Dexamethasone with or without Pembrolizumab in rrMM

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


title: A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AL002 IN PARTICIPANTS WITH EARLY ALZHEIMER’S DISEASE

lead_sponsor: Alector Inc.


title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

lead_sponsor: Incyte Corporation


title: A PHASE 1/2, OPEN-LABEL, DOSE-ESCALATION AND EXPANSION STUDY OF ENTRECTINIB (RXDX-101) IN PEDIATRICS AND YOUNG ADULTS WITH NO CURATIVE FIRST-LINE TREATMENT OPTION OR RECURRENT/REFRACTORY SOLID TUMORS AND PRIMARY CNS TUMORS

lead_sponsor: F. Hoffmann-La Roche Ltd


title: Aldose Reductase Inhibition for Stabilization of Exercise capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients with Diabetic Cardiomyopathy / Stage B Heart Failure at High Risk of Progression to Overt Heart Failure (Stage C Heart Failure)

acronym: ARISE-HF

lead_sponsor: Applied Therapeutics Inc.


title: A phase III study of Lenalidomide and low-dose Dexamethasone with or without Pembrolizumab (MK3475) in newly diagnosed and treatment naïve Multiple Myeloma (KEYNOTE 185).

acronym: Study of Lenalidomide and Dexamethasone with or without Pembrolizumab in Multiple Myeloma


title:
An international, multicentre, efficacy and safety study of I10E in
 initial and maintenance treatment of patients with Chronic
 Inflammatory Demyelinating Polyradiculoneuropathy

acronym: PRISM

lead_sponsor: LFB BIOTECHNOLOGIES


title: A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

lead_sponsor: Talecris Biotherapeutics Inc


title: Randomised double blind placebo controlled pivotal study to evaluate efficacy and safety of rPhleum in adult and adolescent patients suffering from rhinoconjunctivitis +/- controlled Asthma

acronym: 2nd pivotal rPhleum

lead_sponsor: Allergopharma Joachim Ganzer KG


title: A multicenter, multinational phase II study to assess the clinical safety and feasibility of T-DM1 sequentially with anthracyline-based chemotherapy, as adjuvant or neoadjuvant therapy for patients with early stage HER2-positive breast cancer.


title: A Multicentre, Interventional, Non-randomized, Open-label, Single-group Phase III Study to evaluate Plasma-Derived Antihaemophilic Factor/von Willebrand Factor Concentrate (Biostate®) for Immune Tolerance Induction in Male Paediatric Subjects with Haemophilia A (≤2%) who have Developed High-titre Antibodies to Factor VIII (Factor VIII Inhibitors)

acronym: SWIFT-ITI

lead_sponsor: CSL Behring GmbH


title: A 24-Week, Flexible-Dose, Open-label Extension Study of Lurasidone for the Treatment of Bipolar I Depression

lead_sponsor: Dainippon Sumitomo Pharma America Inc.


title: Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis

lead_sponsor: Institut de Recherches Internationales Servier


title: A Phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects.

lead_sponsor: ViiV Healthcare UK Ltd


title: A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriaceae (CRE)

lead_sponsor: Achaogen, Inc.


title: A Phase III Randomised Double-blind Study Comparing Sorafenib With Placebo In Patients With Resected Primary Renal Cell Carcinoma at High or Intermediate Risk of Relapse

acronym: SORCE

lead_sponsor: Medical  Research Council


title:
A Phase 2, Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab Alone or in Combination with Novel Agents in Subjects with Locally Advanced, Unresectable, Stage III Non-small Cell Lung Cancer (COAST)

 Étude de plateforme de phase 2, multicentrique, randomisée, en ouvert, utilisant plusieurs médicaments, visant à évaluer le durvalumab en monothérapie ou en association avec de nouveaux agents chez des sujets atteints de cancer du poumon non à petites cellules de stade III, localement avancé et non résécable (COAST)

acronym: COAST

lead_sponsor: MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC


title: A randomized, sham-injection controlled, double-masked, multicenter trial of microplasmin intravitreal injection for treatment of exudative age-related macular degeneration (AMD).

lead_sponsor: ThromboGenics NV


title: A Phase 2 Study of Panitumumab Plus Irinotecan Followed by Panitumumab Plus AMG 479 in Subjects With Metastatic Colorectal Carcinoma Expressing Wild Type KRAS and Refractory to Oxaliplatin- or Irinotecan- and Oxaliplatin-containing Regimens to Evaluate Mechanisms of Acquired Resistance to Panitumumab

lead_sponsor: Amgen Inc


title:
A prospective, multicenter, open-label, centrally allocated, active-controlled, phase 2 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced/metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line.

 Etude de phase 2, prospective, multicentrique, en ouvert, avec allocation centralisée, contrôlée, visant à comparer l'efficacité et la tolérance de masitinib en association avec gemcitabine versus gemcitabine seule, chez des patientes atteintes d'un cancer de l’ovaire épithélial métastatique/avancé en 2ème ligne de traitement réfractaire à une première ligne de traitement avec sels de platine ou en 3ème ligne de traitement

lead_sponsor: AB Science


title: A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

acronym:
PATINA

 PATINA

lead_sponsor: Alliance Foundation Trials, LLC


title: Efficacy and safety study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.

lead_sponsor: PIERRE FABRE MEDICAMENT


title:
A randomized double-blind, placebo-controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents.

 Une étude de 12 semaines, en double aveugle, groupes paralèlles, 1:1, randomisée versus placebo de l'efficacité et la tolérance de la rispéridone chez les enfants et adolescents de 5,0 à 17,9 ans ayant un trouble des conduites selon les critères du DSM-IV.

acronym:
CONCA

 CONCA

lead_sponsor: Radboud University Medical Centre Nijmegen


title: A blinded, randomized, placebo-controlled trial in genotype 1 hepatitis C-infected subjects to evaluate the efficacy, safety, tolerability and pharmacokinetics of repeated doses of TMC435350, with or without peginterferon alpha-2a and ribavirin.

lead_sponsor: Tibotec Pharmaceuticals Ltd


title: A phase 1/2, open-label study of bosutinib administered in combination with capecitabine in subjects with solid tumor and ErbB2 negative locally advanced or metastatic breast cancer.

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc


title:
A Prospective, Open-label, Long-term Safety and Efficacy Study of
 Teduglutide in Pediatric Patients with Short Bowel Syndrome Who
 Completed TED-C14-006 or SHP633-301

 Original PIP P/238/2010

lead_sponsor: Shire Human Genetic Therapies, Inc.


title: An open-label, multicenter protocol providing pegylated interferon alfa-2a (PEGASYS) as monotherapy or in combination with ribavirin (COPEGUS) for patients with chronic hepatitis C who have participated in previous Roche or Roche partner protocols.

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML

acronym: CLARA-DNX

lead_sponsor: Hospices Civils de Lyon


title:
A Phase 3 Single Arm Study Evaluating the Efficacy and Safety of Gene Therapy in Subjects with Transfusion-dependent β-Thalassemia, who have a β0/β0 Genotype, by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with a Lentiviral βA-T87Q Globin Vector in Subjects ≤50 Years of Age

 Étude de phase 3 à bras unique évaluant l’efficacité et la sécurité de la thérapie génique par greffe de cellules souches autologues CD34+ transduites ex vivo avec un vecteur lentiviral βA-T87Q-globine chez des patients, âgés de 50 ans ou plus, atteints d’une bêta-thalassémie dépendante des transfusions et ayant le génotype β0/β0

lead_sponsor: bluebird bio, Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, Polysomnography plus Outpatient Study to Determine the Safety and Efficacy of 4 mg Ramelteon in Adults with Chronic Insomnia

lead_sponsor: Takeda Global Research & Development Centre (Europe) Ltd.


title: Randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed dose study comparing the efficacy and safety of Lu AA21004 in acute treatment of major depressive disorder in elderly patients

acronym: Not applicable

lead_sponsor: H. Lundbeck A/S


title: Anastrozole monotherapy versus maximal oestrogen blockage with anastrozole and fulvestrant comination therapy: An open, randomised, comparative, phase III multicentre study in postmenopausal women with hormone receptor positive breast cancer in first relapse after primary treatment of localised tumour.

acronym: FACT

lead_sponsor: AstraZeneca AB


title: A multicenter study with an open-label Phase Ib part followed by a randomized, placebo-controlled, double-blind, Phase II part to evaluate efficacy, safety, tolerability, and pharmacokinetics of the DNA-PK inhibitor M3814 in combination with capecitabine and radiotherapy in participants with locally advanced rectal cancer

lead_sponsor: Merck KGaA


title:
A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients with Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6)

 Étude de phase II internationale, multicentrique, menée en ouvert, évaluant la sécurité d’utilisation du durvalumab après une chimiothérapie et une radiothérapie séquentielles chez des patients présentant un cancer bronchique non à petites cellules non résécable de stade III (PACIFIC 6)

acronym: PACIFIC 6


title: A randomized, double-blinded, phase III study of atezolizumab versus placebo in patients with late relapse of epithelial ovarian, fallopian tube, or peritoneal cancer treated by platinum-based chemotherapy and bevacizumab

acronym: ATALANTE : ATezolizumab and Avastin in LAte recurreNT diseasE

lead_sponsor: ARCAGY-GINECO


title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care

lead_sponsor: Kaleido Biosciences


title: Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™)

acronym: CLEAREST™-TRAIL

lead_sponsor: Merck Serono International S.A.


title: A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, PARALLEL GROUP, MULTI-CENTRE PHASE IIB DOSE-FINDING STUDY OF M516102 IN THE TREATMENT OF PRURITUS ASSOCIATED WITH ATOPIC DERMATITIS.

lead_sponsor: Maruho Co., Ltd


title: CONNECTION PLUS:  An Open-Label Extension of the CONNECTION Protocol (DIM14) Evaluating Oral Dimebon in Patients with Alzheimer’s Disease

acronym: CONNECTION Plus

lead_sponsor: Medivation, Inc.


title: Evaluation of Belatacept as First-line Immunosuppression in De Novo Liver Transplant Recipients  Revised Protocol Number 01, incorporating Amendment 02 (version 1.0 dated 22-Oct-07)

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged ≥ 60 with newly diagnosed acute myeloid leukaemia (AML) who are considered unsuitable to receive intensive induction chemotherapy regimens


title: An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 with Exemestane or Fulvestrant in Postmenopausal Women with Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer

lead_sponsor: Amgen Inc.


title: A randomized, multicenter, double-blind, placebo-controlled, Phase 2/3 study of the Bruton’s Tyrosine Kinase inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in the first line treatment of patients with metastatic pancreatic adenocarcinoma

lead_sponsor: Pharmacyclics LLC


title: Phase II Study of ZK 219477 in patients with recurrent glioblastoma

lead_sponsor: European Organisation for Research and Treatment of Cancer


title: A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who did not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

acronym: Rollover Study of Telaprevir (VX-950), Pegasys, and Copegus in Hepatitis C

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Exemestane vs. Exemestane Alone as Second Line Therapy in Post-Menopausal Women with Locally Advanced or Metastatic ER+/PgR+/Her2- Breast Cancer

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis.

acronym: Atacicept in combination with rituximab in subjects with rheumatoid arthritis

lead_sponsor: Merck Serono International


title: A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension

acronym: FREEDOM-M

lead_sponsor: United Therapeutics Corporation


title: A TREATMENT PROTOCOL FOR PATIENTS CONTINUING FROM A PRIOR SU011248 PROTOCOL

lead_sponsor: Pfizer Inc.


title: A Multicenter, Open-Label Extension Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001

lead_sponsor: Wave Life Sciences Ltd.


title: Safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500 mg/200 mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV co-infection, with a pilot evaluation of therapeutic drug monitoring (TDM).  An open-label, multicenter, multinational trial with randomisation to standard of care (SOC) or TDM TPV/r therapy

lead_sponsor: Boehringer Ingelheim France SAS


title: A multinational, multicenter, exploratory pharmacogenomics trial to test the importance of identified genetic markers, and potentially identify new markers of various ovarian responses to GONAL-f® treatment in women undergoing assisted reproduction technology (ART).

acronym: Pharmacogenomics trial of GONAL-f® in ART

lead_sponsor: Merck Serono International, A branch of Laboratoires Serono S.A.


title:
A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents with Recent-Onset Type 1 Diabetes Mellitus

 Extension de l’étude PRV-031-001, multicentrique, internationale visant à évaluer la tolérance à long terme du teplizumab (PRV-031), un anticorps monoclonal anti-CD3 humanisé ne se liant pas au FcR, chez des enfants et des adolescents atteints de diabète de type 1 d’apparition récente

acronym: PROTECT Extension Study

lead_sponsor: Provention Bio, Inc.


title: A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations

lead_sponsor: Incyte Corporation


title: Phase 3b, Randomized Trial of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® (Bortezomib) Induction Therapy in Newly Diagnosed Multiple Myeloma

acronym: ARUMM

lead_sponsor: Celgene Corporation


title:
A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19

 Étude de phase 2 randomisée évaluant l’efficacité et la tolérance de l’acalabrutinib associé aux Meilleurs Soins de Support (Best Supportive Care - BSC) vs Meilleurs Soins de Support chez des patients hospitalisés infectés par le COVID-19

acronym: CALAVI

lead_sponsor: Acerta Pharma B.V.


title: A 104 week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy of aliskiren on the progression of atherosclerosis in patients  with coronary artery disease when added to optimal background therapy

lead_sponsor: Novartis Pharma Services AG


title:
EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX)

 Étude d’extension en ouvert EPITOPE visant à évaluer le bénéfice clinique à long terme et la sécurité d’emploi du DBV712 chez des enfants allergiques à l’arachide (EPOPEX)

acronym: EPOPEX

lead_sponsor: DBV TECHNOLOGIES S.A.


title: A Phase IIb, randomized, double-blind, parallel-group study to assess the efficacy, safety, tolerability, and resistance profile of GSK3640254 in combination with dolutegravir compared to dolutegravir plus lamivudine in HIV-1 infected, treatment-naïve adults

acronym: DYNAMIC

lead_sponsor: ViiV Healthcare UK Limited


title: A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

acronym: ReSPECT

lead_sponsor: Cidara Therapeutics Inc.


title:
Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

 Étude de phase I/II multicentrique visant à évaluer la sécurité d'emploi, la pharmacocinétique et l'efficacité préliminaire d'APL-101 chez des patients atteints de cancer bronchique non à petites cellules avec mutations par saut de l'exon 14 de c-MET et des patients atteints de tumeurs solides avancées avec dérégulation de c-MET

acronym: SPARTA

lead_sponsor: Apollomics, Inc.


title:
A subject-, investigator-, and sponsor-blinded, randomized, placebo-controlled, multicenter study to investigate efficacy, safety, and tolerability of VAY736 in patients with idiopathic pulmonary fibrosis

 Étude multicentrique, contrôlée par placebo, randomisée, pour laquelle les patients, les investigateurs et le promoteur sont en aveugle, visant à examiner l’efficacité, la sécurité d’emploi et la tolérance de VAY736 chez des patients atteints de fibrose pulmonaire interstitielle diffuse (FPID)

lead_sponsor: Novartis Pharma AG


title: Randomised, double-blind, double-dummy, multicentre trial to evaluate the efficacy and safety of three different weekly dosages of calcifediol versus placebo in subjects with either vitamin D deficiency or insufficiency

acronym: WORFEROL

lead_sponsor: FAES FARMA S.A.


title: A Phase 3, Double blind, Randomized, Placebo controlled, Parallel group, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of 2000 mg/kg of Trappsol® Cyclo™ (Hydroxypropyl β cyclodextrin) and Standard of Care Compared to Placebo and Standard of Care in Patients with Niemann Pick Disease Type C1

lead_sponsor: Cyclo Therapeutics, Inc.


title: A Randomized Phase II Study of Fulvestrant in Combination with the dual mTOR Inhibitor AZD2014 or Everolimus or Fulvestrant alone in Estrogen Receptor-Positive Advanced or Metastatic Breast Cancer.

acronym: MANTA

lead_sponsor: Queen Mary, University of London


title: A Phase 2 multicenter, randomized, placebo controlled, double-blind study to assess the safety and efficacy of CC-486 (oral azacitidine) in combination with pembrolizumab (MK-3475) versus pembrolizumab plus placebo in subjects with previously treated locally advanced or metastatic non-small cell lung cancer


title:
A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis

 Une étude de phase 2 de Belantamab Mafodotin chez des patients atteints d'Amylose de type AL, récidivante ou réfractaire

lead_sponsor: European Myeloma Network – EMN


title:
Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia
 The RAPID Study (NODE-301 Part 2)

lead_sponsor: Milestone Pharmaceuticals Inc.


title: Phase 3 Follow-up Study of AAV5-hRKp.RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated with Variants in the RPGR gene

acronym: Long Term Follow-Up study of Gene Therapy Trial for Patients with Retinitis Pigmentosa: RPGR

lead_sponsor: MeiraGTx UK II Limited


title: Phase II randomized trial of MEK inhibitor AS703026 or placebo combined with gemcitabine in chemo-naïve metastatic pancreas cancer subjects

lead_sponsor: Merck Serono S.A. - Geneva


title:
PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Pegzilarginase in Children and Adults with Arginase 1 Deficiency

 Étude PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints [effets de la pegzilarginase sur les critères d’évaluation cliniques relatifs au déficit en arginase 1]) : Une étude de phase III, randomisée, en double aveugle, contrôlée contre placebo, visant à évaluer l’efficacité et la sécurité d’emploi de la pegzilarginase chez des enfants et des adultes présentant un déficit en arginase 1.

lead_sponsor: Aeglea Biotherapeutics, Inc.


title: A six-month double-blind, randomized, placebo-controlled study investigating the safety and tolerability of deferiprone in participants with Friedreich's ataxia

acronym: Not applicable

lead_sponsor: ApoPharma Inc.


title: Adults adminstered Venlafaxine and Eszopiclone Response to Treatment (AVERT): A 31-Week, Efficacy, Safety and Tolerability Study of Eszopiclone 3 mg Co-administered with Venlafaxine in Subjects with Major Depressive Disorder (MDD) and Co-existing Insomnia

lead_sponsor: Sepracor NV in care of Sepracor Inc.


title: A Non-inferiority Comparison of 35mg Delayed-release Risedronate, Administered Once-weekly Either Before or After Breakfast, and 5mg Immediate-release Risedronate, Administered Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis as Assessed Over 2 Years; a Phase III, Multicenter, Double-Blind, Double-dummy, Randomized, Active-controlled, Parallel-group Study

acronym: Fantasia Phase III

lead_sponsor: Procter & Gamble Pharmaceuticals


title: A randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy and safety of two doses of oral microencapsulated grass pollen extract administered prior to and during the the grass pollen season

lead_sponsor: Curalogic A/S


title: A Phase 3, Double-Blind, Double-Dummy, Multi-Center, Prospective, Randomized Study of the Efficacy and Safety of LCP-Tacro™ Tablets, Once Daily, Compared to Prograf® Capsules, Twice Daily, in Combination with Mycophenolate Mofetil for the Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

lead_sponsor: LifeCycle Pharma A/S


title: An international phase III randomised trial comparing in severe Exacerbations of Chronic obstructive pulmonary  disease the efficacy of Helium/Oxygen versus Air/Oxygen administered during spontaneous breathing and intermittent non-invasive ventilation. The E.C.H.O. ICU trial

acronym: ECHO ICU trial

lead_sponsor: Air Liquide


title: A prospective, multi-center, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy (DAPT) in subjects undergoing percutaneous coronary intervention (PCI) with either drug-eluting stent (DES) or bare metal stent (BMS) placement for the treatment of coronary artery lesions.

acronym: DAPT Study

lead_sponsor: HCRI


title: A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of S-888711 tablets administered once-daily for 42 days to adult subjects with relapsed persistent or chronic immune thrombocytopenia with or without prior splenectomy.

lead_sponsor: Shionogi USA, Inc.


title:
An Open-Label, Multinational, Phase 1/2 Study of the Safety and Dose Escalation of SHP648, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing FIX Padua in Hemophilia B Subjects

 Étude de phase I/II internationale en ouvert évaluant la sécurité d’emploi et l’escalade de dose du SHP648, un vecteur viral adéno-associé de sérotype 8 (AAV8) exprimant le facteur IX Padua chez des patients atteints d’hémophilie B

lead_sponsor: Baxalta Innovations GmbH


title:
Randomized, subject and investigator blinded, placebo-controlled
 study to demonstrate the anti-inflammatory
 effect of fevipiprant (QAW039) in moderate-severe asthma
 patients with high sputum and blood eosinophils

 Etude randomisée contrôlée contre placebo, en double aveugle (patients et investigateurs), destinée à démontrer l'effet anti-inflammatoire du fevipiprant (QAW039) chez des patients
 atteints d’asthme modéré à sévère et présentant des taux élevés d’éosinophiles dans le sang et les expectorations

lead_sponsor: Novartis Pharma AG


title: A randomised, double-blind, placebo-controlled, multi national, Phase III study of the efficacy and safety of 300 IR sublingual immunotherapy (SLIT), starting 2 months before the grass pollen season, administered as allergen based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis (with or without asthma)

lead_sponsor: Stallergenes S.A.


title: GF-001001-00 cream.  A multicentre, randomised, double-blind, parallel, placebo-controlled phase II study to assess the efficacy and safety of 3 different doses of GF-001001-00 cream versus placebo cream applied 2 times daily for 7 days in the treatment of adult patients with secondarily-infected traumatic lesions.

lead_sponsor: Ferrer International, SA


title: A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil in Subjects with Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059)

acronym: A Phase II Study of Pembrolizumab in Subjects with Gastric Cancer

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


title: A Phase II randomised, placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine in individuals who started antiretrovirals during primary or chronic infection

lead_sponsor: Inserm-ANRS


title:
A Multicenter, Phase 2 Study of Tesetaxel plus Three Different PD-(L)1 Inhibitors in Patients with Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly Patients with HER2 Negative, Locally Advanced or Metastatic Breast Cancer

 Étude multicentrique de phase 2 portant sur le tésétaxel et trois inhibiteurs différents du PD-(L)1 chez des patients atteints d’un cancer du sein triple-négatif, localement avancé ou métastatique et sur le tésétaxel en monothérapie chez des patients âgés présentant un cancer du sein HER2 négatif, localement avancé ou métastatique

lead_sponsor: Odonate Therapeutics, Inc.


title:
Phase II study examining the activity of L19-IL2 immunotherapy and stereotactic ablative radiotherapy in metastatic non-small cell lung cancer

 Étude de phase II portant sur la combinaison d’une immunothérapie L19-IL2 et d’une radiothérapie (stéréotaxique d'ablation) chez des patients atteints d’un carcinome pulmonaire non à petites cellules métastasé

lead_sponsor: Maastricht University Medical Centre


title:
A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients with Severe Acute Decompensated Alcoholic Hepatitis.

 Etude de phase II, randomisée, en double-aveugle, contrôlée contre placebo, évaluant l’efficacité et la tolérance du DS102 administré par voie orale chez des patients atteints d’hépatite alcoolique aiguë sévère

lead_sponsor: Afimmune


title: A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis.

acronym: NASH-RX

lead_sponsor: Galectin Therapeutics Inc.


title:
OXYTOCIN TREATMENT IN NEONATES AND INFANTS AGED FROM 0 TO 3 MONTHS WITH PRADER-WILLI SYNDROME: A STUDY OF THE SAFETY AND EFFICACY ON ORAL AND SOCIAL SKILLS AND, FEEDING BEHAVIOR OF INTRANASAL ADMINISTRATIONS OF OXYTOCIN VS. PLACEBO (PHASE III CLINICAL TRIAL)

 Traitement par ocytocine chez les nouveau-nés et les nourrissons âgés de 0 à 3 mois présentant un syndrome de Prader-Willi : étude de la tolérance et de l’efficacité sur les troubles de l’oralité, les interactions sociales et le comportement alimentaire d’administrations intra-nasales d’ocytocine versus placebo (Étude clinique de phase III)

acronym:
OTBB3

 OTBB3

lead_sponsor: University Hospital of Toulouse


title: Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients from 6 Months to Less Than 2 Years Old

acronym: SCOB2 (Study Cystadrops® Ophthalmic for Patients Below 2 years)

lead_sponsor: Recordati Rare Diseases


title: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

lead_sponsor: Incyte Corporation


title:
A Phase II, Single Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of MOR00208 Combined with Idelalisib in Patients with Relapsed or Refractory CLL/SLL Previously Treated with Bruton’s Tyrosine Kinase (BTK) Inhibitor.

 Étude de phase II, multicentrique, en ouvert, sur groupe unique visant à évaluer l’efficacité et la sécurité d’emploi du MOR00208 en association avec l’idelalisib chez les patients atteints de LLC/PLL récidivant ou réfractaire précédemment traité par l’inhibiteur de la tyrosine kinase de Bruton (BTK)

lead_sponsor: MorphoSys AG


title:
A Randomized, Open-Label Phase II/III Study With Dendritic Cells Loaded With Allogeneic Tumour Cell Lysate (PheraLys) in Subjects With Mesothelioma as Maintenance Treatment (MesoPher) After Chemotherapy.
 DENIM (DENdritic Cell Immunotherapy for Mesothelioma)

lead_sponsor: Amphera B.V.


title:
A Phase 2 Study of Poziotinib in Patients with Non-Small Cell Lung Cancer, Locally Advanced or Metastatic, with EGFR or HER2 Exon 20 Insertion Mutation (POZITIVE20-1)

 Étude de phase II sur le poziotinib chez des patients atteints d'un cancer du poumon non à petites cellules, localement avancé ou métastatique, ayant une mutation par insertion au niveau de l’exon 20 de l’EGFR ou de l’HER2 (POZITIVE20-1)

lead_sponsor: Spectrum Pharmaceuticals, Inc.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study: 5 Independent Sub-studies of Setmelanotide in Patients with POMC, PCSK1, LEPR, SRC1, SH2B1, and PCSK1 N221D Gene Defects in the Melanocortin-4 Receptor Pathway

acronym: Setmelanotide in patients with specific gene defects

lead_sponsor: Rhythm Pharmaceuticals Inc.


title: A RANDOMIZED PHASE III STUDY OF TEMOZOLOMIDE AND SHORT-COURSE RADIATION VERSUS SHORT-COURSE RADIATION ALONE IN THE TREATMENT OF NEWLY  DIAGNOSED GLIOBLASTOMA MULTIFORME IN ELDERLY PATIENTS

lead_sponsor: EORTC European Organisation for Research and Treatment of Cancer


title: An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus Low-Dose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

acronym: PANCRIT-1 (PANcreatic Cancer RadioImmunoTherapy Trial 1)

lead_sponsor: Immunomedics, Inc.


title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis

lead_sponsor: Corbus Pharmaceuticals, Inc.


title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

lead_sponsor: Celgene Corporation


title: EXPLORE: A phase 2, outcomes assessor-masked, multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration

lead_sponsor: Gyroscope Therapeutics


title:
An Open-label, Phase 1b/2 Study of ACP-196 in Subjects
 with Waldenström Macroglobulinemia

 Etude ouverte de phase 1b/2 de l'ACP-196 chez des patients atteints d'une Macroglobulinémie de Waldenström

lead_sponsor: Acerta Pharma BV


title: An open-label, multicenter, multinational extension study of the long-term safety and pharmacokinetics of repeated biweekly infusions of neoGAA in patients with Pompe disease

lead_sponsor: Genzyme Corporation


title:
A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab as a Treatment Option for Patients with Bullous Pemphigoid

 Étude internationale, randomisée, en double aveugle, en groupes parallèles et contrôlée par placebo, évaluant l’utilisation du benralizumab pour le traitement de patients atteints de pemphigoïde bulleuse

acronym: FJORD

lead_sponsor: AstraZeneca AB


title: A Randomized double-blind placebo-controlled multicenter Phase 3 study of efficacy and safety of AR-301 as adjunct therapy to antibiotics in the treatment of Ventilator-Associated Pneumonia (VAP) caused by S. aureus

lead_sponsor: Aridis Pharmaceuticals, Inc.


title: REDUCE - Multicenter, prospective, randomized study investigating the efficacy and safety of a reduced immunosuppressive therapy with tacrolimus once daily in comparison to standard triple immunosuppression in senior renal transplant recipients

acronym: REDUCE

lead_sponsor: Charité Universitätsmedizin Berlin


title:
A Phase lllb, open-label, single-arm, single-dose, multicenter study to evaluate the safety, tolerability and efficacy of gene replacement therapy with intravenous OAV101 (AVXS-101) in pediatric patients with spinal muscular atrophy (SMA)

 Etude de phase IIIb, multicentrique, en ouvert, à un seul bras, évaluant la sécurité d’emploi, la tolérance, et l’efficacité d’une dose unique de thérapie génique par OAV101 (AVXS-101), administrée par voie intraveineuse, chez des patients pédiatriques atteints d’amyotrophie spinale

acronym: SMART

lead_sponsor: Novartis Pharma AG


title:
A Phase 1/2, Multicentre, Open-label Study to Evaluate the
 Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric
 Patients Who Are Receiving or Who Are About to Receive Treatment with Opioids

lead_sponsor: Shionogi B.V.


title: A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients who are Anti-PD-1 or Anti-PD-L1 Treatment Naïve

lead_sponsor: Kartos Therapeutics, Inc.


title: A RANDOMIZED, DOUBLE BLIND, MULTICENTER, MULTINATIONAL, PLACEBO CONTROLLED, PARALLEL GROUP, SINGLE DOSE, ADAPTIVE EFFICACY AND SAFETY STUDY OF GLENZOCIMAB USED AS AN ADD-ON THERAPY ON TOP OF STANDARD OF CARE IN THE 4.5 HOURS FOLLOWING AN ACUTE ISCHEMIC STROKE

acronym: ACTISAVE

lead_sponsor: ACTICOR BIOTECH


title: A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)

lead_sponsor: Seagen Inc.


title: A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination with Other Anti-Tumor Agents as a Maintenance Treatment in Participants with Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress with First Line Platinum-Containing Chemotherapy

acronym: JAVELIN Bladder Medley

lead_sponsor: Merck Healthcare KGaA


title: A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

acronym: Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

lead_sponsor: Amgen Inc


title: Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

acronym: ALPINE 4

lead_sponsor: NGM Biopharmaceuticals, Inc.


title: A randomized, multicenter, parallel-group, Phase III study to compare the efficacy of arfolitixorin versus leucovorin in combination with 5 fluorouracil, oxaliplatin, and bevacizumab in patients with advanced colorectal cancer.

lead_sponsor: Isofol Medical AB


title:
A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine plus Cisplatin Versus Placebo in Combination with Gemcitabine plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers (TOPAZ-1)

 Étude internationale, multirégionale, de phase III randomisée, en double aveugle, contrôlée versus placebo, comparant en traitement de 1ère ligne le durvalumab en association avec la gemcitabine et le cisplatine à un placebo en association avec la gemcitabine et le cisplatine chez des patients atteints d’un cancer des voies biliaires avancé (étude TOPAZ-1)

acronym: TOPAZ-1 Study


title:
TEMOkids study (ORP-TMZ-I- b): A Population pharmacokinetic, acceptability and safety study for KIMOZO, a paediatric oral suspension of temozolomide

 Etude TEMOkids (ORP-TMZ-I- b): Etude de pharmacocinétique de population, d’acceptabilité et de sécurité d’emploi de Kimozo, suspension buvable pédiatrique de témozolomide

acronym:
TEMOkids study

 Etude TEMOkids

lead_sponsor: ORPHELIA Pharma


title: A Phase 1/2 Study of ARQ 092 (Miransertib) in Subjects with PIK3CA-related Overgrowth Spectrum and Proteus Syndrome

lead_sponsor: ArQule, Inc.


title: A Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of FOLFIRINOX (FFX) versus Combination of CPI-613 with modified FOLFIRINOX (mFFX) in Patients with Metastatic Adenocarcinoma of the Pancreas

acronym: PANC003 (also known as “AVENGER 500”)

lead_sponsor: Rafael Pharmaceuticals, Inc


title:
A Phase 1b/2 study of derazantinib as monotherapy and combination therapy with paclitaxel, ramucirumab or atezolizumab in patients with HER2-negative gastric adenocarcinoma harboring FGFR genetic aberrations (FIDES-03)

 Étude de phase 1b/2 portant sur le dérazantinib en monothérapie et en traitement d’association avec le paclitaxel, le ramucirumab ou l’atézolizumab chez des patients atteints d’un adénocarcinome gastrique HER2 négatif porteur d’aberrations des gènes FGFR (FIDES-03)

lead_sponsor: Basilea Pharmaceutica International Ltd.


title:
A Phase 1b/3 double-blind, randomized, active-controlled, 3-stage, biomarker adaptive study of tazemetostat or placebo in combination with lenalidomide plus rituximab in subjects with relapsed/refractory follicular lymphoma

 Étude de phase 1b/3 randomisée, en double aveugle, en 3 étapes, avec design adaptatif selon biomarqueur, du tazémétostat ou placebo en association au lénalidomide et rituximab chez des patients atteints d’un lymphome folliculaire en rechute ou réfractaire

lead_sponsor: Epizyme, Inc.


title:
A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis

 Étude de phase 3 multicentrique, randomisée, en double aveugle, contrôlée par placebo et par traitement comparateur actif, visant à évaluer l’efficacité et la sécurité d’emploi de BMS-986165 chez des sujets atteints de psoriasis en plaques modéré à sévère

lead_sponsor: Bristol-Myers Squibb Company


title:
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR Study)

 Étude randomisée, en double aveugle, contrôlée par placebo, en groupes parallèles, visant à évaluer l’efficacité et la sécurité de BHV-3241 chez des patients atteints d’atrophie multisystématisée (étude M-STAR).

lead_sponsor: Biohaven Pharmaceuticals, Inc


title: A Double-Masked, Randomized, Controlled, Multiple-Dose Study to Evaluate the Efficacy, Safety and Tolerability of QR-421a in Subjects with Retinitis Pigmentosa (RP) due to Mutations in Exon 13 of the USH2A Gene with Early to Moderate Vision Loss

acronym: Celeste

lead_sponsor: ProQR Therapeutics IV B.V.


title: A Randomized, Controlled, Open-label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination with RP1 in Patients with Advanced Cutaneous Squamous Cell Carcinoma

lead_sponsor: Replimune, Inc.


title: Randomized phase III trial on NIraparib-TSR-042 (dostarlimab) vs physician’s choice CHEmotherapy in recurrent, ovarian, fallopian tube or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)

acronym: NItCHE

lead_sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE


title: Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)

lead_sponsor: ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE


title: A Double-Blind, Placebo-Controlled, Randomized Study to Assess the Durability of Effect and Safety of Nemolizumab for 24 Weeks in Subjects with Prurigo Nodularis

lead_sponsor: Galderma S.A.


title:
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously
 as Monotherapy and in Combination With Pembrolizumab in
 Subjects With Advanced Solid Tumors
 (ARTISTRY-2)

 Étude de phase 1/2 sur l’ALKS 4230 administré par voie sous-cutanée en monothérapie et en association avec le pembrolizumab à des sujets présentant des tumeurs solides à un état avancé - ARTISTRY-2 (001)

lead_sponsor: Alkermes, Inc.


title:
Neo-AEGIS (NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study): Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (Modified MAGIC regimen) vs. neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction

 Neo-AEGIS (Essai international de traitement NEO-adjuvant dans les Adénocarcinomes de l’oEsophage et de la jonction oesoGastrique) : Essai randomisé  comparant la chimiothérapie néo-adjuvante et adjuvante (protocole MAGIC modifié de chimiothérapie péri-opératoire) versus la radio-chimiothérapie néo-adjuvante (protocole CROSS) dans les adénocarcinomes de l’oesophage et de la jonction oesogastrique.

acronym: Neo-AEGIS

lead_sponsor: ICORG


title:
A 2-Stage (Open-Label Run-in followed by Randomized Withdrawal),
 Double-Blind, Placebo-Controlled, Phase 2 study of Setmelanotide in
 Patients with Specific Gene Defects in the Melanocortin-4 Receptor
 Pathway

lead_sponsor: Rhythm Pharmaceuticals Inc.


title:
A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 in patients with active psoriatic arthritis

 Etude randomisée en double aveugle, contrôlée versus placebo, de preuve de concept et de recherche de dose du BI 655066 chez des patients atteints de rhumatisme psoriasique actif

lead_sponsor: Boehringer Ingelheim France


title: A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease

lead_sponsor: Eisai Ltd.


title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

acronym: Intermittent and Daily Treatment for Episodic Asthma (IDEA)

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD

lead_sponsor: Schering-Plough Research Institute


title: An observational, safety follow-up extension to studies 2203 and 2203E1 to assess the safety of AAE581 in postmenopausal women with osteopenia/osteoporosis

lead_sponsor: Novartis Pharma Services AG


title: A randomized phase II trial of ridaforolimus (AP23573; MK-8669) compared to progestin or chemotherapy in female adult patients with advanced endometrial carcinoma

lead_sponsor: ARIAD Pharmaceuticals, Inc.


title: Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study

lead_sponsor: Pierre Fabre Médicament


title: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, 12-Week Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood P/266/2011, P267/2011, P268/2011

acronym: PASCAL 401

lead_sponsor: Kowa Research Europe, Ltd.


title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Phase II Study to Compare the Efficacy, Safety and Tolerability of Olaparib Versus Placebo When Given in Addition to Abiraterone Treatment in Patients With Metastatic Castrate-Resistant Prostate Cancer Who Have Received Prior Chemotherapy Containing Docetaxel

lead_sponsor: AstraZeneca AB


title: A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1


title: An Open-Label Extension Study of the Long-Term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis (IPF) Who Complete the CAPACITY Studies

acronym: Open-Label Extension of Pirfenidone CAPACITY Studies

lead_sponsor: InterMune, Inc.


title: NON-INFERIORITY STUDY OF A METRONIDAZOLE 0.75% CREAM VERSUS REFERENCE THERAPY IN THE LOCAL TREATMENT OF PAPULOPUSTULAR ROSACEA.

lead_sponsor: Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre


title: Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4)


title: A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic Melanoma

lead_sponsor: Synta Pharmaceuticals Corp.


title: An open-label, single-arm, multi-center phase 2 trial with ofatumumab in patients with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

acronym: Ofatumumab in patients with relapsed DLBCL ineligible for or relapsed after transplant

lead_sponsor: Genmab A/S


title: Phase II open label study to evaluate the safety of a second i.p. infusion cycle of catumaxomab in patients with malignant ascites due to carcinoma, requiring their first therapeutic puncture after treatment in the CASIMAS study (IP-CAT-AC-03)

acronym: SECIMAS

lead_sponsor: Fresenius Biotech GmbH


title: A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects with Enthesitis Related Arthritis

lead_sponsor: Abbott GmbH & Co. KG (Abbott)


title: A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Extended-Release (ER) Niacin and Laropiprant (ERN/LRPT) in Patients with Dyslipidemia

lead_sponsor: Merck & Co., Inc.


title: A multicenter, randomized, double-blind, 8 week study to evaluate the dose response, efficacy and safety of aliskiren in pediatric hypertensive patients 6-17 years of age.


title: A randomized, observer-blind, active-controlled phase III study to demonstrate the superior efficacy of GSK Biologicals’ adjuvanted influenza candidate vaccine [GSK2186877A], administered intramuscularly in elderly aged 65 years or above, as compared to Fluarix™.

acronym: FLU NG-006 PRI

lead_sponsor: GlaxoSmithKline Biologicals


title:
A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered
 with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)

lead_sponsor: Abbott GmbH & Co. KG


title: A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder.

lead_sponsor: GlaxoSmithKline Research & Development


title: A randomised, double-blind, placebo-controlled, multi-national, multi-centre, Phase III study to assess the long term efficacy, carry-over effect and safety of two dosing regimens of 300 IR sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to patients suffering from grass pollen rhinoconjunctivitis

lead_sponsor: Stallergenes S.A.


title: A Multi-center, Open-label, 5-Part Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aprepitant and Fosaprepitant Dimeglumine in Pediatric Patients Receiving Emetogenic Chemotherapy

lead_sponsor: Laboratoires Merck Sharp & Dhome-Chibret


title: The H10 EORTC/GELA randomized intergroup trial on early FDG-PET scan guided treatment adaptation versus standard combined modality treatment in patients with supradiaphragmatic stage I/II Hodgkin's lymphoma

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


title: An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given with a light meal

lead_sponsor: Novartis Pharma Services AG


title: An open-label, randomized, multicenter, active-controlled, dose-ranging study to evaluate the safety and efficacy of albinterferon alfa 2b administered every 4 weeks plus ribavirin in interferon alfa-naïve patients with genotype 2/3 chronic hepatitis C


title: A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin

lead_sponsor: Schering Plough Research Institute, A Division of Schering Corporation


title: A Phase IIb/III Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Obese Patients and in Overweight Patients with Obesity-related Co-morbidities.

lead_sponsor: Laboratoires Merck Sharp & Dohme-Chibret


title: A randomized, eight-week double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / amlodipine (300/5 mg and 300/10 mg) in comparison with aliskiren 300 mg in patients with essential hypertension not adequately responsive to aliskiren 300 mg monotherapy.


title: A dose-finding study of efficacy and safety of F13640  in patients with moderate to severe painful peripheral diabetic polyneuropathy

acronym: BEST- Diabetes study (Befiradol Dose-Finding Study in diabetic patients)

lead_sponsor: Institut de Recherche Pierre Fabre


title: Multi-center, prospective trial to demonstrate Improved Metabolic control of PPEN vs DDDD in DIAbetic CAPD patients -The IMPENDIA Trial

acronym: IMPENDIA

lead_sponsor: Baxter Healthcare Corporation


title:
First international Inter-Group Study for nodular
 lymphocyte predominant Hodgkin`s Lymphoma in Children and Adolescents

lead_sponsor: Martin Luther University of Halle/Wittenberg


title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)


title: The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

lead_sponsor: Allergan Limited


title: Multinational, multicenter, prospective, long-term safety and efficacy follow-up study after Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns (HOLOCORE-FU)

acronym: HOLOCORE FU

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: A Long-Term, Open-Label Safety and Efficacy Study of Xyrem (sodium oxybate) in Subjects with Fibromyalgia

lead_sponsor: Jazz Pharmaceuticals, Inc.


title: A Multicenter, Randomized, Double-Blind, “Crossover” Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK 0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia.


title: An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

acronym: RESTORE™ S

lead_sponsor: PDL BioPharma, Inc.


title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control


title: A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

lead_sponsor: Archimedes Development Ltd.


title: Randomized, Phase II Study of MK-3475 versus Chemotherapy in Patients with Advanced Melanoma

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


title:
Study NOG112264, a Phase II Study of Ozanezumab
 (GSK1223249) versus Placebo in the Treatment of Amyotrophic
 Lateral Sclerosis

acronym: Ozanezumab Phase II study in patients with ALS

lead_sponsor: GlaxoSmithKline Research and Development Limited


title: Long-Term Follow-Up of Subjects in a Phase 2 or 3 Clinical Trial in which SCH 503034 was Administered for the Treatment of Chronic Hepatitis C

lead_sponsor: Schering-Plough Research Institute


title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

lead_sponsor: AVEO Pharmaceuticals, Inc.


title: NEMO1 : An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.

lead_sponsor: Great Ormond Street Hospital for Children NHS Trust


title: Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of intravenous tapentadol solution for injection for the treatment of post-surgical pain in children aged from birth to less than 2 years, including preterm neonates.

lead_sponsor: Grünenthal GmbH


title: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real-World, Open-Label, Quality of Life Study

acronym: Quality of Life study of AR101 CODIT

lead_sponsor: Aimmune Therapeutics, Inc.


title: A Phase III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection who are on Opiate Substitution Therapy.

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


title: Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial

acronym: INFAST

lead_sponsor: Schering-Plough Research Institute, a Division of Schering Corporation


title: A PHASE 3, OPEN-LABEL STUDY OF THE SAFETY AND EFFECTIVENESS OF AA4500 ADMINISTERED TWICE PER TREATMENT CYCLE FOR UP TO FOUR TREATMENT CYCLES (2 x 4) IN MEN WITH PEYRONIE’S DISEASE

acronym: Open Label Study of AA4500 in Men With Peyronie's Disease

lead_sponsor: Auxilium UK Limited


title: Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C

lead_sponsor: Schering Plough Research Institute, A Division of Schering Corporation


title: "A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with an Oral Bisphosphonate"

lead_sponsor: Merck & Co., Inc.


title: A multicenter, double-blind, randomized, 52 week extension study to evaluate the long term safety, tolerability and efficacy of aliskiren compared to enalapril in pediatric hypertensive patients 6-17 years of age

lead_sponsor: Novartis Pharma Services AG


title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the combination regimen of MK-5172 and MK-8742 +/-Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection

acronym: MK-5172 + MK-8742 +/- Ribavirin Pilot Study in GT1 TN Patients

lead_sponsor: Merck Sharp & Dohme Corp.


title: A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of apricitabine versus lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase

lead_sponsor: Avexa Limited


title: A double-blind, randomized, multicenter, parallel group study to evaluate the efficacy, tolerability, and safety of treatment with the combination of valsartan/amlodipine 160/5 mg compared to amlodipine 10 mg in patients with essential hypertension not adequately controlled with amlodipine 5 mg alone


title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis

 ÉTUDE DE PHASE 3, MULTICENTRIQUE, RANDOMISÉE, EN DOUBLE AVEUGLE, CONTRÔLÉE CONTRE PLACEBO ET COMPARATEUR ACTIF, À GROUPES PARALLÈLES, DESTINÉE À ÉVALUER L'EFFICACITÉ ET LA TOLÉRANCE DU BIMÉKIZUMAB CHEZ DES PATIENTS ADULTES PRÉSENTANT UN PSORIASIS EN PLAQUES CHRONIQUE MODÉRÉ À SÉVÈRE

lead_sponsor: UCB Biopharma SPRL


title: Randomized, double-blind, double-dummy, active controlled, multicentre, non-inferiority phase-III study to compare the pharmacokinetic, efficacy and safety of gabapentin liquid formulation to tramadol in children from 3 months to less than 18 years of age experiencing moderate to severe chronic neuropathic or mixed pain.

acronym: Efficacy and safety study to compare gabapentin versus tramadol in paediatric patients

lead_sponsor: PHARM – Pharmaceutical Research Management srl


title:
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination with Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

 Étude internationale, multicentrique, de phase III, randomisée, en ouvert comparant le MEDI4736 en association au tremelimumab ou en monothérapie à une chimiothérapie conventionnelle à base de platine chez des patients atteints d’un cancer bronchique non à petites cellules (CBNPC) de stade avancé ou métastatique en première ligne de traitement (MYSTIC)

acronym:
MYSTIC

 MYSTIC

lead_sponsor: AstraZeneca AB


title: A randomized Phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS)

lead_sponsor: TRACON Pharmaceuticals, Inc.


title: An international multicenter phase II randomized trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy

acronym: VERITAS

lead_sponsor: Gustave Roussy


title: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naïve Patients With Chronic Hepatitis C Infection.

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients with Sarcopenia

lead_sponsor: Laboratoires Merck Sharp & Dohme- Chibret