title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Zeiser R, von Bubnoff N, Butler J, Mohty M, Niederwieser D, Or R, Szer J, Wagner EM, Zuckerman T, Mahuzier B, Xu J, Wilke C, Gandhi KK, Socié G; REACH2 Trial Group. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020 May 7;382(19):1800-1810. doi: 10.1056/NEJMoa1917635. Epub 2020 Apr 22.

ReferenceCitation: Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Japan
Czechia
Hong Kong
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Canada
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

summary: To evaluate the safety and efficacy of ruxolitinib compared to Best Available Therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation


title: A Randomized Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

source: euctr

lead_sponsor: Amgen Inc

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title:
A multicenter study to evaluate long-term safety and tolerability of open label  sacubitril/valsartan in pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed study CLCZ696B2319 (PANORAMA-HF)

 Etude multicentrique, en ouvert, évaluant la tolérance et la sécurité d’emploi à long terme de LCZ696 (sacubitril/valsartan) chez des patients pédiatriques atteints d’insuffisance cardiaque due à une dysfonction ventriculaire gauche systolique ayant terminé l'étude CLCZ696B2319

lead_sponsor: Novartis Pharma AG

status: Ongoing

status_simplified: Ongoing


title: Phase II Trial of Pembrolizumab (MK-3475) in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Chemotherapy

acronym: Phase  II  Trial  of  MK-3475  in  Subjects  with  mCRPC  with  Prior Chemotherapy

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


title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors

lead_sponsor: Novo Nordisk A/S


title: European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial

acronym: EU-SolidAct

lead_sponsor: Oslo University Hospital

lead_sponsor_type: academique


title:
A 52-week, randomised, double-blind, double-dummy, parallel group,multi-centre, non-inferiority study assessing exacerbation rate,
 additional measures  of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab

 Étude de 52 semaines de non-infériorité, randomisée, en double aveugle, avec double placebo, en groupes parallèles, multicentrique, évaluant le taux d’exacerbation, le contrôle de l’asthme et la sécurité d’emploi chez des patients adultes et adolescents atteints d’asthme sévère présentant un phénotype éosinophilique et traités par GSK3511294, par rapport au traitement par mépolizumab ou benralizumab

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Phase III, Observer-Blind, Randomized, Non-influenza Vaccine Comparator-Controlled, Parallel-Group, Multi-Country Study in Children Aged 6-35 Months to Assess the Safety and Efficacy of Abbott’s Candidate Quadrivalent Influenza Vaccine.

lead_sponsor: Abbott Biologicals B.V.

status: Not Authorised

status_simplified: Unknown


title:
A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS)

 Etude multicentrique de 48 semaines, menée en double-aveugle sur 6 groupes, randomisée et contrôlée par placebo, destinée à évaluer la sécurité d’emploi et l’efficacité de plusieurs doses de CFZ533 par voie sous-cutanée, dans deux populations distinctes de patients atteints du syndrome de Sjögren (TWINSS)

acronym: TWINSS


title: ALLTogether1– A Treatment study protocol of the ALLTogether Consortium for children and young adults (0-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL)

lead_sponsor: Karolinska University Hospital


title: A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults and Adolescents (Phase 3; Protocol No. MK-5592-069)


title: A Phase III Double-blind, Randomized, Placebo-Controlled Study assessing the Efficacy, Safety and Tolerability of Idebenone in Patients with Duchenne Muscular Dystrophy Receiving Glucocorticoid Steroids

acronym: SIDEROS

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Limited


title:
A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis

 Étude multicentrique, randomisée, partiellement en aveugle et contrôlée contre traitement actif, du sécukinumab, destinée à démontrer la réduction de la progression radiographique versus GP2017 (biosimilaire adalimumab) à 104 semaines et évaluer à long terme la sécurité d'emploi, la tolérance et l'efficacité jusqu'à 2 ans, chez les patients atteints d'une spondylarthrite ankylosante active

acronym: SURPASS


title:
Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

 Étude de phase III randomisée, contre placebo, en double aveugle comparant des gélules d'acide nor-ursodésoxycholique au placebo dans le traitement de la cholangite sclérosante primitive

lead_sponsor: Dr. Falk Pharma GmbH


title:
A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021

 Etude randomisée, à 3 bras de traitement, en double aveugle, de non-infériorité, d’une durée de 2 ans, comparant l’efficacité et la sécurité d’emploi de l’ofatumumab et du siponimod versus fingolimod chez des patients pédiatriques atteints de sclérose en plaques, suivie d’une extension en ouvert.

acronym: NEOS


title:
A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator’s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation

 Étude de phase 3 randomisée, multicentrique, en ouvert, comparant l'efficacité et la tolérance de l'Acalabrutinib (ACP-196) associé au Venetoclax avec et sans Obinutuzumab, versus une chimio-immunothérapie au choix de l'investigateur chez des patients atteints d’une leucémie lymphoïde chronique naïfs de traitement, sans délétion 17p ni mutation TP53.

acronym: Not available at this time

lead_sponsor: Acerta Pharma B.V.


title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

lead_sponsor: Arena Pharmaceuticals Inc.


title: A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.

acronym: Safinamide in IPD with motor fluctuations, as add-on to levodopa

lead_sponsor: Merck Serono S.A. - Geneva


title: Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults

acronym: DisCoVeRy

lead_sponsor: INSERM


title: A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage treated by endovascular coiling.

acronym: CONSCIOUS 3

lead_sponsor: Actelion Pharmaceuticals Ltd.


title: A multi-center, randomized, double-blind, placebo-controlled phase III trial comparing the efficacy of bevacizumab in combination with rituximab and CHOP (RA-CHOP) versus rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL)

acronym: MAIN

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary
 Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid

lead_sponsor: Intercept Pharmaceuticals, Inc.


title: Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia

lead_sponsor: Milestone Pharmaceuticals Inc.


title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

lead_sponsor: Galderma S.A.


title:
A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY,
 ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS

 ÉTUDE MULTICENTRIQUE DE PHASE 3B, RANDOMISÉE, EN DOUBLE AVEUGLE, À DOUBLE PLACEBO, AVEC TRAITEMENT DE RÉFÉRENCE, VISANT À ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ D’EMPLOI DE L’ABROCITINIB COMPARÉ AU DUPILUMAB CHEZ DES PARTICIPANTS ADULTES ATTEINTS DE DERMATITE ATOPIQUE MODÉRÉE À SÉVÈRE RECEVANT UN TRAITEMENT TOPIQUE DE FOND

lead_sponsor: Pfizer Inc.

status: Prematurely Ended


title:
European Network of Paediatric Hodgkin Lymphoma Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents (EuroNet-PHL-C2)

 EuroNet-PHL-C2.  Seconde Etude Internationale de l’inter-groupe des Lymphomes de Hodgkin Classiques de l’Enfant, de l’Adolescent et de l’Adulte jeune (EuroNet-PHL-C2)

lead_sponsor: JUSTUS LIEBIG UNIVERSITY OF GIESSEN


title: An Open-Label, Multicenter, Efficacy and Safety Study to Evaluate Two Treatment Algorithms in Subjects with Moderate to Severe Crohn's Disease

acronym: CALM

lead_sponsor: Abbott GmbH & Co. KG


title: A MULTICENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS WITH EPILEPSY ≥4 YEARS TO <17 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

lead_sponsor: UCB BIOSCIENCES, Inc.


title:
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E MUTANT COLORECTAL CANCER

 ÉTUDE OUVERTE DE PHASE 3, MULTICENTRIQUE, RANDOMISÉE DE LA COMBINAISON ENCORAFÉNIB ET CÉTUXIMAB COMME TRAITEMENT DE
 PREMIÈRE INTENTION, AVEC OU SANS CHIMIOTHÉRAPIE, COMPARÉE AU TRAITEMENT STANDARD, AVEC UNE PHASE PRELIMINAIRE DE SECURITE POUR L’ASSOCIATION AVEC LA CHIMIOTHERAPIE CHEZ LES PATIENTS PRESENTANT UN CANCER COLORECTAL MÉTASTATIQUE AVEC
 MUTATION BRAF V600E

acronym: The BREAKWATER Study


title:
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia

 Étude de phase 3 randomisée, multicentrique, en ouvert portant sur l’acalabrutinib (ACP-196) comparé au choix de traitement de l’investigateur, soit idélalisib plus rituximab ou bendamustine plus rituximab, chez des sujets atteints de leucémie lymphoïde chronique en rechute ou réfractaire

lead_sponsor: Acerta Pharma BV


title: A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION

acronym: ADVANCE-extension

lead_sponsor: Arena Pharmaceuticals, Inc.


title: Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ? 2 to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis.

lead_sponsor: Amgen Inc.


title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

lead_sponsor: Rigel Pharmaceuticals, Inc.


title: A Phase III Randomized Open-label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects with Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus that have Progressed after First-Line Standard Therapy (KEYNOTE-181)

acronym: Study of Pembrolizumab vs Docetaxel, Paclitaxel or Irinotecan in Subjects with Esophagus Carcinoma

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


title:
A Multicenter, Double-blind, Randomized Withdrawal extension study of subcutaneous secukinumab to demonstrate long-term efficacy, safety and tolerability in subjects with moderate to severe hidradenitis suppurativa

 Etude d’extension multicentrique, en double-aveugle, randomisée, de retrait du traitement, évaluant l’efficacité, la sécurité d’emploi et la tolérance à long terme du secukinumab administré en sous-cutané chez des patients présentant une hidradénite suppurée modérée à sévère

lead_sponsor: Novartis Pharma AG


title:
A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

 Etude de phase III, multicentrique, randomisée, en double aveugle, en groupes parallèles, contrôlée par placebo, évaluant l’efficacité et la sécurité d’emploi de LNP023 chez des patients atteints de néphropathie primaire à IgA


title:
Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) - DHELIVER

 Étude multicentrique et randomisée de phase IIB, contrôlée par placebo et en double aveugle, visant à évaluer l’efficacité et la sécurité du dispositif HepaStem chez les patients atteints d’une insuffisance hépatique aiguë sur maladie chronique du foie (ACLF) - DHELIVER

acronym: HEP102 - DHELIVER

lead_sponsor: Promethera Biosciences


title: Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia Coronavirus COVID-19 (REMAP-CAP-COVID-19)

acronym: REMAP-CAP

lead_sponsor: University Medical Center Utrecht


title:
A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination with Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects with Metastatic Castration-Resistant Prostate Cancer

 Étude de phase 3, randomisée, en ouvert et contrôlée, évaluant le cabozantinib (XL184) en association avec l’atézolizumab vs un deuxième traitement hormonal novateur (THN) chez des patients atteints d’un cancer de la prostate métastatique et résistant à la castration

lead_sponsor: Exelixis, Inc.


title:
A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

 Etude internationale de phase III, en double aveugle, multicentrique, contrôlée versus placebo évaluant le durvalumab en traitement néoadjuvant/adjuvant chez des patients atteints d’un cancer du poumon non à petites cellules de stade II et III résécable (AEGEAN)

acronym: AEGEAN

lead_sponsor: AstraZeneca AB


title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

lead_sponsor: Millennium Pharmaceuticals, Inc.


title: A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor

acronym: ESCAPE-TRD

lead_sponsor: Janssen-Cilag International NV


title: A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients With Duchenne Muscular Dystrophy

lead_sponsor: Sarepta Therapeutics, Inc.


title: Paediatric Hepatic International Tumour Trial

acronym: PHITT

lead_sponsor: University of Birmingham


title: Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease

acronym: FLOW

lead_sponsor: Novo Nordisk A/S


title:
A Phase 3, Randomised, Rater-Blinded, Multi-Centre Study to Evaluate the Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects Aged 18 and Older with an Extension Phase of up to 60 Months

 Étude multicentrique de phase III randomisée, en aveugle pour les évaluateurs, visant à évaluer l’efficacité et la sécurité du WTX101 administré pendant 48 semaines, par rapport au traitement standard, chez des patients atteints de la maladie de Wilson âgés de 18 ans ou plus avec une phase d’extension de 60 mois maximum

lead_sponsor: Wilson Therapeutics AB


title:
A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents

 Etude de phase II, multicentrique, randomisée, en ouvert évaluant la tolérance et l’efficacité de 3 schémas d’administration différents de panobinostat administré par voie orale, associé au bortézomib administré par voie sous-cutanée et à la dexaméthasone administrée par voie orale, chez des patients atteints de myélome multiple en rechute ou réfractaire, ayant déjà reçu des agents immunomodulateurs

lead_sponsor: Secura Bio, Inc.


title:
A phase I/II study of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) antibody-radionuclide-conjugate for treatment of relapsed non-Hodgkin lymphoma.

 Étude de phase I/II portant sur le radio-immunoconjugué lilotomab satetraxetan marqué au lutétium (177Lu) (Betalutin®) pour le traitement d'un lymphome non hodgkinien récidivant

lead_sponsor: Nordic Nanovector ASA


title: A phase III randomized, double-blind study of induction(daunorubicin/cytarabine) and consolidation (high dose cytarabine) chemotherapy + midostaurin (PKC412) (IND # 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML)

lead_sponsor: Novartis Pharma Services AG


title:
A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Previously Untreated Multiple Myeloma who are Eligible for High-dose Therapy

 Étude de phase 3 comparant l’association de daratumumab, VELCADE (bortézomib), lénalidomide et dexaméthasone (D-VRd) par rapport au traitement par VELCADE (bortézomib), lénalidomide et dexaméthasone (VRd) chez des patients présentant un myélome multiple non traités auparavant mais éligibles à un traitement à fortes doses

acronym:
The Perseus trial

 Etude Perseus

lead_sponsor: European Myeloma Network (EMN)


title: A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants

lead_sponsor: Premacure AB


title:
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric
 Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia In First or Second Relapse

lead_sponsor: Sanofi-aventis recherche & developpement


title: A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis

acronym: GEMINI 2

lead_sponsor: Genzyme Corporation


title: A Long-term Access Programme for Subjects with Severe Asthma who Participated in a GSK-sponsored Mepolizumab Clinical Study

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)

acronym: IMBRELLA B

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related Genes (including BRCA1/2) (VIOLETTE)

 Étude de phase II, ouverte, randomisée, multicentrique visant à évaluer la sécurité d'emploi et l'efficacité d'agents ciblant la réparation des dommages à l'ADN en combinaison avec l'olaparib par rapport à l'olaparib en monothérapie dans le traitement de patientes atteintes de cancer du sein triple négatif métastatique stratifiées en fonction des altérations des gènes impliqués dans la réparation par recombinaison homologue (HRR) (y compris BRCA1/2) (étude VIOLETTE)


title: A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

lead_sponsor: Incyte Corporation


title:
A randomized, double-blind, multicenter study assessing short (16 weeks) and long-term efficacy (up to 1 year), safety, and tolerability of 2 subcutaneous secukinumab dose regimens in adult patients with moderate to severe hidradenitis suppurativa

 Etude multicentrique, randomisée en double aveugle, évaluant
 l'efficacité à court terme (16 semaines) et à long terme (jusqu’à 1 an), la sécurité d’emploi et la tolérance de 2 schémas osologiques souscutanés de secukinumab chez des patients adultes présentant une hidradénite suppurée modérée à sévère (SUNRISE)

acronym: SUNRISE

lead_sponsor: Novartis Pharma AG


title: PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE® ) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

lead_sponsor: Pfizer Inc.


title:
A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors

 Etude de phase III, multicentrique, randomisée, en ouvert, évaluant ABL001 par voie orale versus bosutinib chez des patients atteints de leucémie myéloïde chronique en phase chronique (LMC-PC) précédemment traités par au moins 2 inhibiteurs de tyrosine kinase


title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

 Étude de phase 3, randomisée, en double aveugle, contrôlée contre placebo, multicentrique, évaluant le traitement d'entretien par niraparib chez des patientes atteintes d’un cancer de l'ovaire avancé avec défaut de recombinaison homologue (HRD-positif) en réponse à une chimiothérapie de première ligne à base de platine

lead_sponsor: TESARO, Inc.


title: A Randomized, Double-Blind, Dose Finding and Comparison Study of the Safety and Efficacy of a High Dose of Eteplirsen, Preceded by an Open-label Dose Escalation, in Patients with Duchenne Muscular Dystrophy With Deletion Mutations Amenable to Exon 51 Skipping

lead_sponsor: Sarepta Therapeutics, Inc.


title:
I6T-MC-AMAP
 A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-
 Term Efficacy and Safety of Mirikizumab in Patients with Moderately to
 Severely Active Ulcerative Colitis (LUCENT 3)

 I6T-MC-AMAP
 Étude d’extension de Phase 3, multicentrique, en ouvert visant à évaluer la sécurité et l’efficacité à long terme du mirikizumab chez les patients atteints de rectocolite hémorragique active modérée à sévère (LUCENT 3)

acronym: LUCENT 3

lead_sponsor: Eli Lilly and Company


title:
A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MeRmaiD-1)

 Étude multicentrique de phase III, randomisée, en double aveugle, contrôlée versus placebo, évaluant l’efficacité du durvalumab en traitement adjuvant associé à une chimiothérapie à base de platine chez des patients présentant un cancer du poumon non à petites cellules (CPNPC) de stade II-III complètement réséqué (MeRmaiD-1)

lead_sponsor: AstraZeneca AB


title: A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced  Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

acronym: Pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select,  Advanced Gastric  or GEJ Adenocarcinoma

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


title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined with Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

acronym: PIVOT - 12

lead_sponsor: Nektar Therapeutics


title: Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache

lead_sponsor: H. Lundbeck A/S


title:
An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

 Étude ouverte, multicentrique, internationale, visant à évaluer l'innocuité et l’efficacité à long terme du durvalumab chez des patients qui reçoivent ou qui ont déjà reçu du durvalumab dans d’autres protocoles (WAVE)

acronym: WAVE


title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
 (CheckMate 7FL: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 7FL)

acronym: Nivo/Placebo with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in ER+/HER2-Breast Cancer

lead_sponsor: Bristol-Myers Squibb International Corporation


title:
A phase III, multicenter, randomized, open-label trial toevaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE)

 Étude de phase III, multicentrique, randomisée, ouverte, évaluant l'efficacité et la tolérance du ribociclib associé à l'endocrinothérapie en tant que traitement adjuvant chez des patients atteints d'un cancer du sein précoce positif aux récepteurs hormonaux, HER2 négatif (New Adjuvant TriAl with Ribociclib [LEE011] : NATALEE).


title: A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

lead_sponsor: MedImmune, LLC


title:
A Randomized, Double blind, Active Control Study of the Safety and Efficacy of PRX-102 compared to Agalsidase Beta on Renal Function in Patients with Fabry Disease Previously Treated With Agalsidase
  Beta

 Étude randomisée, en double aveugle, contre comparateur actif, de la sécurité et l’efficacité de PRX-102 par rapport à l’agalsidase bêta sur la fonction rénale chez des patients atteints de la maladie de Fabry précédemment traités par agalsidase bêta

lead_sponsor: Protalix Ltd.


title: A Phase 3, randomized, double-blind, efficacy and safety study comparing SAR442168 to placebo in participants with primary progressive multiple sclerosis (PERSEUS)

acronym: PERSEUS


title:
A 12-week, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study to assess the efficacy and safety of CSJ117, when added to existing asthma therapy in patients ≥18 years of age with severe uncontrolled asthma.

 Étude de 12 semaines, multicentrique, randomisée, en double aveugle, groupes parallèles, contrôlée versus placebo, visant à évaluer l’efficacité et la sécurité d’emploi du CSJ117, lorsqu’il est ajouté au traitement de l’asthme existant chez les patients âgés de ≥ 18 ans souffrant d’asthme sévère non contrôlé


title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

lead_sponsor: Celgene Corporation


title: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis

acronym: HARBOR

lead_sponsor: Blueprint Medicines Corporation


title:
A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-HER2 Therapies and Require Systemic Treatment.

 Étude randomisée de phase III comparant le margetuximab plus chimiothérapie au trastuzumab plus chimiothérapie dans le traitement de patients atteints de cancer du sein métastatique HER2+ ayant reçu deux traitements anti-HER2 précédents et nécessitant un traitement systémique

lead_sponsor: MacroGenics, Inc.


title: A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia

lead_sponsor: Erasmus Medical Center


title:
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD)

 Elacestrant en monothérapie contre traitement standard du cancer du sein métastatique RO+ HER2- après traitement préalable par inhibiteur de CDK4/6: une étude de phase 3, randomisée, ouverte, contrôlée et multicentrique (EMERALD)

acronym: EMERALD

lead_sponsor: Radius Pharmaceuticals Inc.


title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)


title: A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)

lead_sponsor: Amgen Inc


title:
A phase 2b, open-label, efficacy and safety study of ABX464 as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

 Étude de phase IIb en ouvert évaluant l’efficacité et la sécurité d’emploi de l’ABX464 en tant que traitement d’entretien chez des patients atteints de rectocolite hémorragique modérée à sévère.

lead_sponsor: ABIVAX


title: A Randomized, Double-Blind, Phase 3 Study to Evaluate the Activity of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic, Anemic Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera (PV) Myelofibrosis, or Post Essential Thrombocythemia (ET) Myelofibrosis who were Previously Treated with JAK Inhibitor Therapy

lead_sponsor: Sierra Oncology, Inc.


title:
A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer
 patients

lead_sponsor: TESARO Inc.


title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled with Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin

acronym: SWITCH

lead_sponsor: Merck Sharp & Dohme Corp.


title: A 52-week open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimer's disease (REFLECT-4).

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Mono- or Dual Combination Oral Antihyperglycemic Therapy

acronym: TECOS

lead_sponsor: Merck & Co., Inc.


title: A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease

lead_sponsor: Millennium Pharmaceuticals, Inc.


title: An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).

acronym: GO-MORE

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


title: A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease

acronym: A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease


title: A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.

lead_sponsor: Abbott GmbH & Co. KG (Abbott)


title: Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomised, double-blind, double-dummy, parallel group, one-year study).

acronym: POET

lead_sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG


title: A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 μg o.d. vs inhaled tiotropium 18 μg o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD

acronym: INVIGORATE

lead_sponsor: Novartis Pharma Services AG


title:
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects with a Recent Acute Coronary Syndrome
 The ATLAS ACS 2 TIMI 51 Trial (The second trial of Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome)
 Amendment INT-1

acronym: The ATLAS ACS 2 TIMI 51 Trial

lead_sponsor: Janssen-Cilag International N.V.


title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed - The TRILOGY ACS Study

acronym: Trilogy ACS

lead_sponsor: Eli Lilly and Company


title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral Intertrochanteric Fracture of the Proximal Femur, Status Post Fixation with a Sliding Hip Screw or Intramedullary Nail


title: An Open, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis

lead_sponsor: Amgen Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus

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


title:
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES: A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER CLINICAL STUDY

 — OPEN-LABEL ESL EXTENSION —

acronym: not applicable

lead_sponsor: BIAL - Portela & Ca, S.A.


title: A Pan-European randomized, parallel group, two-arm placebo-controlled, double-blind multicenter study of Rimonabant 20mg once daily in the treatment of abdominally obese patients with impaired fasting blood glucose with or without other comorbidities

lead_sponsor: sanofi aventis groupe


title: AN EXPLORATORY TRIAL TO ASSESS NATURALISTIC SAFETY AND EFFICACY OUTCOMES IN PATIENTS TRANSITIONED TO USTEKINUMAB FROM PREVIOUS METHOTREXATE THERAPY (TRANSIT)

acronym: TRANSIT

lead_sponsor: Janssen-Cilag International NV


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome

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


title:
A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with
 MK-5172 in a Prior Clinical Trial


title: Randomized, multinational, double-blind study, comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy

acronym: CURRENT

lead_sponsor: sanofi-aventis recherche et développement


title:
A phase 3  multi-center, long-term extension study investigating the efficacy and safety of  PF-04965842, with or without topical medications, administered to subjects aged 12 years and older with moderate to severe atopic dermatitis

 Étude d’extension à long terme, multicentrique, de phase III, évaluant l’efficacité et la tolérance du PF-04965842, avec ou sans médicaments topiques, administrés à des sujets âgés de 12 ans et plus, atteints de dermatites atopiques modérées à graves

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


title: A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer´s disease (EVOKE)

lead_sponsor: Novo Nordisk A/S


title: A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft versus host disease after allogenic stem cell transplantation

acronym: REACH 3

lead_sponsor: Novartis Pharma AG


title: An Open-Label Extension Study of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis

acronym: ELEVATE UC OLE

lead_sponsor: Arena Pharmaceuticals Inc.


title:
An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

 Etude d’extension, multicentrique, en ouvert, à un seul bras évaluant la sécurité d’emploi, la tolérance et l’efficacité à long-terme de l’ofatumumab chez des patients atteints de sclérose en plaques récurrente.


title:
A randomized, double-blind, placebo -controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT)

 Etude multicentrique randomisée, en double aveugle, contrôlée par placebo, évaluant l’effet de l'inclisiran sur les événements cardiovasculaires majeurs chez des patients atteints d'une maladie cardiovasculaire établie (VICTORION-2 PREVENT)

acronym: Study of inclisiran to prevent cardiovascular (CV) events in participants with established cardiovas


title: A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis


title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease

lead_sponsor: Millennium Pharmaceuticals, Inc.


title: Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study.

acronym: SIGNIFY

lead_sponsor: Institut de Recherches Internationales Servier


title: A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus

summary: This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Rosenstock J, Fonseca VA, Gross JL, Ratner RE, Ahrén B, Chow FC, Yang F, Miller D, Johnson SL, Stewart MW, Leiter LA; Harmony 6 Study Group. Advancing basal insulin replacement in type 2 diabetes inadequately controlled with insulin glargine plus oral agents: a comparison of adding albiglutide, a weekly GLP-1 receptor agonist, versus thrice-daily prandial insulin lispro. Diabetes Care. 2014 Aug;37(8):2317-25. doi: 10.2337/dc14-0001. Epub 2014 Jun 4.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Taiwan
Brazil
Hong Kong
Spain
United Kingdom
Korea, Republic of
United States
France
India
Peru
Mexico
Philippines
Germany
South Africa

intervention_type: Biological


intervention_type: Drug

title: An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures

lead_sponsor: UCB Pharma

type: EudraCT Number

design_allocation: Non-Randomized

location_country:
Denmark
Romania
Spain
Greece
Austria
Italy
Russian Federation
Finland
Switzerland
United States
France
Turkey
Mexico
Bulgaria
Czechia

summary: To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.


primary_purpose: Prevention

title: An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of Prophylactic Administration of Long Acting rFVIIa (LA-rFVIIa) in Haemophilia A or B Patients With Inhibitors

type: Registry Identifier

type: Other Identifier

study_start_date_type: Actual

ReferenceCitation: Ljung R, Karim FA, Saxena K, Suzuki T, Arkhammar P, Rosholm A, Giangrande P; Pioneer™1 Investigators. 40K glycoPEGylated, recombinant FVIIa: 3-month, double-blind, randomized trial of safety, pharmacokinetics and preliminary efficacy in hemophilia patients with inhibitors. J Thromb Haemost. 2013 Jul;11(7):1260-8. doi: 10.1111/jth.12237.

location_country:
Brazil
Serbia
United Kingdom
Former Serbia and Montenegro
Sweden
France
United States
Turkey
South Africa
Japan
Malaysia

summary: This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.


title: A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Paul C, Reich K, Gottlieb AB, Mrowietz U, Philipp S, Nakayama J, Harfst E, Guettner A, Papavassilis C; CAIN457A2211 study group. Secukinumab improves hand, foot and nail lesions in moderate-to-severe plaque psoriasis: subanalysis of a randomized, double-blind, placebo-controlled, regimen-finding phase 2 trial. J Eur Acad Dermatol Venereol. 2014 Dec;28(12):1670-5. doi: 10.1111/jdv.12359. Epub 2014 Jan 7.

location_country:
United States
Israel
France
Norway
Iceland
Japan
Germany

summary: The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).


title: An Open-Label Study To Determine Safety, Tolerability And Efficacy Of Long -Term Oral Lacosamide (LCM) As Adjunctive Therapy In Children With Epilepsy

lead_sponsor: UCB BIOSCIENCES, Inc.

location_country:
Poland
Italy
Mexico
Ukraine
Hungary
United States
France
China
Belgium
Japan
Germany

summary: SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy.


title: A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

lead_sponsor: Shire

ReferenceType: background

ReferenceCitation: Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31.

ReferenceCitation: Pape UF, Iyer KR, Jeppesen PB, Kunecki M, Pironi L, Schneider SM, Seidner DL, Lee HM, Caminis J. Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials. Therap Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Canada
United States
France
Germany

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej

location_facility: University Health Network - Toronto General Hospital

location_facility: Med. Klinik m.S. Hepatologie und Gastroenterologie

location_facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP

location_facility: Azienda Universitaria Policlinico Federico II

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik I

summary: This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.


primary_purpose: Supportive Care

title: A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss Due to Androgen-Deprivation Therapy

lead_sponsor: Amgen

location_country:
Poland
Slovenia
Greece
Latvia
Australia
New Zealand
Canada
Russian Federation
Ukraine
Hungary
United States
France
India
South Africa
Mexico
Bulgaria
Slovakia
Czechia

summary: This is a phase 3, randomized, double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in men with non-metastatic prostate cancer receiving denosumab for bone loss due to androgen deprivation therapy.


title: A Phase Ib/II, Open-label Study of the Safety, Tolerability, and Efficacy of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab

summary: This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.

ReferenceCitation: Miller KD, Diéras V, Harbeck N, Andre F, Mahtani RL, Gianni L, Albain KS, Crivellari D, Fang L, Michelson G, de Haas SL, Burris HA. Phase IIa trial of trastuzumab emtansine with pertuzumab for patients with human epidermal growth factor receptor 2-positive, locally advanced, or metastatic breast cancer. J Clin Oncol. 2014 May 10;32(14):1437-44. doi: 10.1200/JCO.2013.52.6590. Epub 2014 Apr 14.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
Canada
United States
France
Belgium
Germany


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel, Dose-Ranging Study to Evaluate The Efficacy, Safety, Tolerability, and Pharmacodynamics of NBI-6024 In Adult and Adolescent Patients With New Onset Type 1 Diabetes Mellitus

summary:
This was a study designed to evaluate the efficacy of multiple doses of an investigational drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age) patients with new onset type 1 diabetes mellitus, on endogenous insulin production.

A total of 188 patients were enrolled in the study. The study was divided into three periods: screening, treatment (comprising an induction phase and maintenance phase), and follow-up.

NBI-6024 was generally well tolerated and exhibits a benign safety profile, as there were no significant safety issues with NBI-6024 treatment. In summary, NBI-6024 did not demonstrate statistically significant efficacy compared with placebo.

primary_purpose: Basic Science

ReferenceCitation: Walter M, Philotheou A, Bonnici F, Ziegler AG, Jimenez R; NBI-6024 Study Group. No effect of the altered peptide ligand NBI-6024 on beta-cell residual function and insulin needs in new-onset type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2036-40. doi: 10.2337/dc09-0449. Epub 2009 Aug 18.

lead_sponsor: Neurocrine Biosciences

location_country:
Spain
United Kingdom
Finland
Canada
Czech Republic
France
South Africa
Germany

location_facility: Center Hospitalier Universitaire de Sherbrooke

location_facility: University Hospital and School of Medicine

location_facility: Diabetes Center for Children and Adolescents


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

summary: This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

ReferenceCitation: Forester BP, Sajatovic M, Tsai J, Pikalov A, Cucchiaro J, Loebel A. Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study. Am J Geriatr Psychiatry. 2018 Feb;26(2):150-159. doi: 10.1016/j.jagp.2017.08.013. Epub 2017 Oct 10.

lead_sponsor: Sunovion

location_country:
Poland
Romania
Russian Federation
Canada
Czech Republic
Lithuania
Ukraine
France
United States
India
Peru
Colombia
Japan
South Africa
Slovakia

location_facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

location_facility: Crimean republican Clinical Psychiatric Hospital

location_facility: Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital

location_facility: Seskines Outpatient Clinic, Public Institution

location_facility: Centro de Investigaciones del Sistema Nerviosa Limitada-Gr

location_facility: Russian State Medical University of RosZdrav

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations

location_facility: St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"

location_facility: Hopital Caremeau, Service de Psychiatrie A

location_facility: Mental Illness Treatment Rehabilitation Foundation (MITR)

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika

location_facility: Centro de Investigacion y Atencion para la Salud Mental

location_facility: Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM

location_facility: Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie

location_facility: University of California at Irvine Medical Center

location_facility: Silutes Mental Health and Psychotherapy Center, JSC

location_facility: Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia

location_facility: Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1

location_facility: Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI

location_facility: MCB Clinical Research Centers-Colorado Springs

location_facility: Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry

location_facility: Pro mente sana s.r.o. Psychiaricka ambulancia

location_facility: Brij Psychiatry Hospital & Muskaan Research Centre

location_facility: Kyiv City Psychoneurological Hospital #2

location_facility: Brain Mind Behaviour Neurosciences Research Institute

location_facility: National Center of Neurology and Psychiatry

location_facility: Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Spitalul Clinic de Urgenta Militar Central

location_facility: Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie

location_facility: Mahatma Gandhi Institute of Medical Sciences

location_facility: California Neuropsychopharmacology Clinical Research Instit

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia

location_facility: Artemis Institute for Clinical Research LLC

location_facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea

location_facility: Bekhterev Scientific Research Psychoneurological Institute

location_facility: Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia

location_facility: Kaunas Hospital Division Marui Hospital, Public Institution

location_facility: Seth K M School of P G Medicine & Research

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: University of South Florida Institute - Tampa

location_facility: Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy

location_facility: Zirmunai Mental Health Center, Public Institution

location_facility: Centrul de Recuperare si Reabilitare Gura Ocnitei

location_facility: Moscow Medical Academy name I.M. Sechenov

location_facility: Kohnodai Hp., National Center for Global Health and Medicine

location_facility: Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie

location_facility: Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Saint Anne, s.r.o., Psychiatricke oddeleni

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA

location_facility: Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.


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

ReferenceType: result

ReferenceCitation: Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.

ReferenceCitation: Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.

ReferenceCitation: Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.

ReferenceCitation: Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.

ReferenceCitation: Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.

ReferenceCitation: Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.

ReferenceCitation: McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.

location_country:
Russian Federation
Czech Republic
Ukraine
India
United States
France
South Africa
Romania

location_facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

location_facility: Sheppard Pratt Health System,6501 North Charles Street

location_facility: American Medical Research Inc.,1200 Harger Road Suite 415

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor

location_facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea

location_facility: Bekhterev Scientific Research Psychoneurological Institute

location_facility: Depression and Anxiety Disorders Research Institute

location_facility: Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia

location_facility: Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230

location_facility: Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

location_facility: Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103

location_facility: Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340

location_facility: Excell Research, Inc,3998 Vista Way,Suite 100

location_facility: California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200

location_facility: Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Hopital Caremeau, Service de Psychiatrie A

location_facility: Spitalul Clinic de Urgenta Militar Central

location_facility: Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B

location_facility: Florida Clinical Research Center, LLC,3914 State Road 64 East

location_facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3

location_facility: University of California at Irvine Medical Center

location_facility: Mental Illness Treatment Rehabilitationi Foundation

location_facility: Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209

location_facility: Chair of Psychiatry and Medical Psychology

location_facility: CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I


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

summary: This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

ReferenceCitation: Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):169-77. doi: 10.1176/appi.ajp.2013.13070985.

location_country:
Poland
Russian Federation
Czech Republic
Ukraine
India
United States
France
South Africa
Romania
Germany

location_facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

location_facility: Sheppard Pratt Health System,6501 North Charles Street

location_facility: Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy

location_facility: American Medical Research Inc.,1200 Harger Road Suite 415

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea

location_facility: Bekhterev Scientific Research Psychoneurological Institute

location_facility: Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia

location_facility: Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric

location_facility: Moscow Medical Academy named I.M. Sechenov

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry

location_facility: American Medical Research, Inc., 1200 Harger Road Suite 415

location_facility: Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209

location_facility: Capital Clinical Research,5515 Security Lane, Suite 525

location_facility: Mental Illness Treatment Rehabilitation Foundation (MITR)

location_facility: Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie

location_facility: Midwest Clinical research Center, One Elizabeth Place, Suite G-3

location_facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street

location_facility: Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM

location_facility: Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog

location_facility: FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200

location_facility: Lake Charles Clinical Trials LLC,700 Spring Forest Road

location_facility: Odesa Regional Psychoneurological Dispensary

location_facility: Depression and Anxiety Disorders Research Institue

location_facility: CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1


title: An Open-label, Multicenter Phase II Extension of Study 28063 (ATAMS) to Obtain Long-term Follow-up Data in Subjects With Relapsing Multiple Sclerosis Treated With Atacicept for up to 5 Years (ATAMS-Extension)

acronym: ATAMS ext

summary:
This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).

This extension study consists of two parts. Part A will be double blind and Part B will be open label. During Part A, subjects initially randomized to atacicept will continue to receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a week subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive atacicept at 150 mg once a week subcutaneously during Part A. Once the results of ATAMS are available and the atacicept dose with the best benefit / risk ratio has been identified, all subjects will be switched to this dose and will continue the extension study open-label (Part B). Throughout the study, subjects and investigators will remain blinded with respect to initial and part A treatment allocation/dose.

status: Terminated

ReferenceCitation: Kappos L, Hartung HP, Freedman MS, Boyko A, Radü EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.

lead_sponsor: EMD Serono

location_country:
Spain
United Kingdom
Russian Federation
Australia
Lebanon
Canada
Czech Republic
Lithuania
Netherlands
Sweden
Switzerland
Ukraine
United States
France
New Caledonia
Belgium
Germany


title: Model 4396 Left Ventricular Lead Study

summary: This study is designed to show that a new lead, which paces the left bottom chamber (left ventricle) of the heart, is safe and effective. Using a lead on the left side of the heart has been shown to potentially improve heart failure symptoms. The shape and size of this new lead may make it a good choice for patients or physicians.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Denmark
Saudi Arabia
Italy
Austria
Australia
Canada
United States
France

intervention_type: Device


title: An Open, Randomized, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate Together With a Randomized Placebo Controlled Double Blind Fermagate Comparison in Hemodialysis Patients With Hyperphosphatemia

study_completion_date_type: Anticipated

lead_sponsor: Ineos Healthcare Limited

enrollment_type: Anticipated

location_country:
Poland
Brazil
Spain
Australia
New Zealand
Canada
United States
France
Malta
South Africa
Germany

location_facility: Nephrology Associates of Northern Virginia

location_facility: Nephrology Educational Services and Research

location_facility: Faculdade de Ciencias Medicas de Sorocaba - Hosp Santa Lucin

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Long Island Hypertension and Nephrology PLLC

location_facility: Hospital Universitario da Univ Federal de Juiz de Fora

location_facility: Clinical Research Associates of Tidewater

location_facility: Western Nephrology & Metabolic Bone Disease PC

location_facility: Arizona Kidney Disease and Hypertension Center

location_facility: NZOZ Miedzynarodowe Centrum Dializ Poznan Odz. Rawicz

location_facility: Kansas Nephrology Research Institute LLC

location_facility: Scott and White Memorial Hospital and Clinic

location_facility: SC Nephrology & Hypertension Center Inc.

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Brookdale Physicians Dialysis Associates

location_facility: Internal Medicine Kidney and Hypertension Center

location_facility: London Health Science Centre - University Campus Site

summary:
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.

The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.


title: International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer

acronym: STARS

summary: Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.

ReferenceCitation: Park S, Kim HJ, Park IK, Kim YT, Kang CH. Stereotactic ablative radiotherapy versus surgery in older patients with stage I lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):74-80. doi: 10.1093/ejcts/ezab045.

ReferenceCitation: Chang JY, Senan S, Paul MA, Mehran RJ, Louie AV, Balter P, Groen HJ, McRae SE, Widder J, Feng L, van den Borne BE, Munsell MF, Hurkmans C, Berry DA, van Werkhoven E, Kresl JJ, Dingemans AM, Dawood O, Haasbeek CJ, Carpenter LS, De Jaeger K, Komaki R, Slotman BJ, Smit EF, Roth JA. Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials. Lancet Oncol. 2015 Jun;16(6):630-7. doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13. Erratum in: Lancet Oncol. 2015 Sep;16(9):e427.

lead_sponsor: Accuray Incorporated

location_country:
United States
China
Taiwan
France

location_facility: CyberKnife Center of WanFang Medical Hospital

intervention_type: Radiation


acronym: REFLEXION

title: Double-blind Extension of the Study 27025 (REFLEX) to Obtain Long-term Follow-up Data in Patients With Clinically Definite MS and Patients With a First Demyelinating Event at High Risk of Converting to MS, Treated With Rebif® New Formulation (REFLEXION)

lead_sponsor: Merck KGaA, Darmstadt, Germany

ReferenceCitation: Comi G, De Stefano N, Freedman MS, Barkhof F, Uitdehaag BM, de Vos M, Marhardt K, Chen L, Issard D, Kappos L. Subcutaneous interferon β-1a in the treatment of clinically isolated syndromes: 3-year and 5-year results of the phase III dosing frequency-blind multicentre REFLEXION study. J Neurol Neurosurg Psychiatry. 2017 Apr;88(4):285-294. doi: 10.1136/jnnp-2016-314843. Epub 2016 Dec 30.

location_country:
Croatia
Serbia
Spain
Italy
Romania
Belgium
Poland
Portugal
Austria
Russian Federation
Argentina
Israel
Slovakia
Lebanon
Canada
Germany
Bulgaria
Greece
Latvia
Estonia
Finland
Czech Republic
France
Morocco

location_facility:
Research Site
Reserch Site

summary: REFLEXION is a double blind extension of the study 27025 (NCT00404352) (REFLEX). The purpose of the study is to obtain long-term follow-up data in subjects with clinically definite multiple sclerosis (MS) and subjects with a first demyelinating event at high risk of converting to MS, treated with fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF).


title: Prognostic Significance and Longitudinal Assessment of Patient-reported Quality of Life and Symptoms in Myelodysplastic Syndromes. A Large-scale International, Observational Study: PROMYS Study

acronym: PROMYS

summary:
RATIONALE: Gathering information about quality of life, fatigue, and other symptoms from patients with myelodysplastic syndromes may help doctors learn more about the disease and may help plan treatment.

PURPOSE: This clinical trial is studying quality of life and symptoms in patients with newly diagnosed myelodysplastic syndromes.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Efficace F, Gaidano G, Sprangers M, Cottone F, Breccia M, Voso MT, Caocci G, Stauder R, Di Tucci AA, Sanpaolo G, Selleslag D, Angelucci E, Platzbecker U, Mandelli F. Preference for involvement in treatment decisions and request for prognostic information in newly diagnosed patients with higher-risk myelodysplastic syndromes. Ann Oncol. 2014 Feb;25(2):447-54. doi: 10.1093/annonc/mdt557.

ReferenceCitation: Caocci G, Voso MT, Angelucci E, Stauder R, Cottone F, Abel G, Nguyen K, Platzbecker U, Beyne-Rauzy O, Gaidano G, Invernizzi R, Molica S, Criscuolo M, Breccia M, Lübbert M, Sanpaolo G, Buccisano F, Ricco A, Palumbo GA, Niscola P, Zhang H, Fenu S, La Nasa G, Mandelli F, Efficace F. Accuracy of physician assessment of treatment preferences and health status in elderly patients with higher-risk myelodysplastic syndromes. Leuk Res. 2015 Aug;39(8):859-65. doi: 10.1016/j.leukres.2015.05.012. Epub 2015 Jun 12.

ReferenceCitation: Efficace F, Gaidano G, Breccia M, Criscuolo M, Cottone F, Caocci G, Bowen D, Lübbert M, Angelucci E, Stauder R, Selleslag D, Platzbecker U, Sanpaolo G, Jonasova A, Buccisano F, Specchia G, Palumbo GA, Niscola P, Wan C, Zhang H, Fenu S, Klimek V, Beyne-Rauzy O, Nguyen K, Mandelli F. Prevalence, severity and correlates of fatigue in newly diagnosed patients with myelodysplastic syndromes. Br J Haematol. 2015 Feb;168(3):361-70. doi: 10.1111/bjh.13138. Epub 2014 Oct 1.

ReferenceCitation: Efficace F, Gaidano G, Breccia M, Voso MT, Cottone F, Angelucci E, Caocci G, Stauder R, Selleslag D, Sprangers M, Platzbecker U, Ricco A, Sanpaolo G, Beyne-Rauzy O, Buccisano F, Palumbo GA, Bowen D, Nguyen K, Niscola P, Vignetti M, Mandelli F. Prognostic value of self-reported fatigue on overall survival in patients with myelodysplastic syndromes: a multicentre, prospective, observational, cohort study. Lancet Oncol. 2015 Nov;16(15):1506-1514. doi: 10.1016/S1470-2045(15)00206-5. Epub 2015 Sep 21.

ReferenceCitation: Efficace F, Cottone F, Abel G, Niscola P, Gaidano G, Bonnetain F, Anota A, Caocci G, Cronin A, Fianchi L, Breccia M, Stauder R, Platzbecker U, Palumbo GA, Luppi M, Invernizzi R, Bergamaschi M, Borin L, Di Tucci AA, Zhang H, Sprangers M, Vignetti M, Mandelli F. Patient-reported outcomes enhance the survival prediction of traditional disease risk classifications: An international study in patients with myelodysplastic syndromes. Cancer. 2018 Mar 15;124(6):1251-1259. doi: 10.1002/cncr.31193. Epub 2017 Dec 12.

ReferenceCitation: Efficace F, Cottone F, Oswald LB, Cella D, Patriarca A, Niscola P, Breccia M, Platzbecker U, Palumbo GA, Caocci G, Stauder R, Ricco A, Petranovic D, Caers J, Luppi M, Fianchi L, Frairia C, Capodanno I, Follini E, Sarlo C, Fazi P, Vignetti M. The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index. Leukemia. 2020 Sep;34(9):2451-2459. doi: 10.1038/s41375-020-0746-8. Epub 2020 Feb 21.

lead_sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

location_country:
Croatia
Taiwan
Brazil
United Kingdom
Italy
Austria
United States
France
China
Belgium
Germany
Czechia

location_facility: Asl Di Asti - Ospedali Riuniti - Presidio Ospedaliero Cardinal G. Massaia - Sc Oncologia

location_facility: Ematologia - Dipartimento di Medicina Clinica e Sperimentale

location_facility: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

location_facility: Aou Arcispedale Sant'Anna - Uoc Ematologia E Fisiopatologia Della Coagulazione

location_facility: Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST

location_facility: S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

location_facility: Curitiba Unidade de Hematologia - Hemoterapia e Oncologia. Setor de Transplante de Medula Ossea. Complexo Hospital de Clinicas da Universidade Federal do Parana (CHC-UFPR)

location_facility: Aou Città Della Salute E Della Scienza - Ospedale S. Giovanni Battista Molinette

location_facility: Divisione di Ematologia Ospedale "Santa Maria Goretti"

location_facility: Università degli Studi - Policlinico di Tor Vergata

location_facility: Unità Operativa Ematologia 1 - Università degli Studi di Bari

location_facility: AZ Sint-Jan AV, Department of Hematology

location_facility: U.O.A. di Medicina Trasfusionale e DH di Ematologia - ASL TO 4 Ospedale di Ivrea

location_facility: Department of Hematology - Universitatsklinikum Carl Gustav Carus

location_facility: Med. Int. ed Oncologia Medica IRCCS Policlinico S. Matteo

location_facility: ASL N.8 - Ospedale "A. Businco" - Unità Operativa di Ematologia e Trapianto di Midollo

location_facility: Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: SOS Dipartimento di Oncoematologia Osp. Rovigo

location_facility: Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Divisione Ematologia - Università Campus Bio-Medico

location_facility: Hematology - Clinical Hospital Centre Rijeka - Faculty of Medicine - University of Rijeka

location_facility: ASL Le1 P.O. Vito Fazzi - U.O. di Ematologia

location_facility: Asl Di Piacenza - Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti

location_facility: Complesso Ospedaliero S. Giovanni Addolorata

location_facility: Saint - Cloud Medecin des CLCC Hematologie Service E Hopital ReneHuguenin - Institut Curie

location_facility: Divisione Ematologia - Azienda Ospedaliera Universitaria "San Martino""

location_facility: Università degli Studi "La Sapienza" - Dip. Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

location_facility: Memorial Sloan-Kettering Cancer Center (MSKCC)

location_facility: Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova - Irccs - Sc Ematologia

location_facility: UO Ematologia - AOU Policlinico di Modena

location_facility: Purpan Hospital - Internal Medicine Department

location_facility: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

location_facility: U.O. Ematologia e Trapianto di Midollo - Ist. Scientifico Ospedale San Raffaele

location_facility: Asst Di Monza - Ospedale S. Eugenio - Uo Ematologia E Cta

intervention_type: Other


title: A Multicenter, Multinational, Longitudinal Clinical Assessment Study of Subjects With Mucopolysaccharidosis IVA (Morquio Syndrome)

summary: This multicenter, multinational, longitudinal study will quantify endurance and respiratory function in subjects diagnosed with MPS IVA and will better characterize the spectrum of symptoms and biochemical abnormalities in MPS IVA disease over time.

ReferenceCitation: Martell LA, Cunico RL, Ohh J, Fulkerson W, Furneaux R, Foehr ED. Validation of an LC-MS/MS assay for detecting relevant disaccharides from keratan sulfate as a biomarker for Morquio A syndrome. Bioanalysis. 2011 Aug;3(16):1855-66. doi: 10.4155/bio.11.172.

lead_sponsor: BioMarin Pharmaceutical

location_country:
Taiwan
Brazil
United Kingdom
Italy
Netherlands
Argentina
Canada
United States
France
Germany


ipd_sharing: Undecided

title: A Single Arm, Phase II, Open-Label Study to Determine the Efficacy of 100mg Twice Daily Oral Dosing of Midostaurin Administered to Patients With Aggressive Systemic Mastocytosis or Mast Cell Leukemia +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease

ReferenceCitation: Hartmann K, Gotlib J, Akin C, Hermine O, Awan FT, Hexner E, Mauro MJ, Menssen HD, Redhu S, Knoll S, Sotlar K, George TI, Horny HP, Valent P, Reiter A, Kluin-Nelemans HC. Midostaurin improves quality of life and mediator-related symptoms in advanced systemic mastocytosis. J Allergy Clin Immunol. 2020 Aug;146(2):356-366.e4. doi: 10.1016/j.jaci.2020.03.044. Epub 2020 May 11.

ReferenceCitation: Gotlib J, Kluin-Nelemans HC, George TI, Akin C, Sotlar K, Hermine O, Awan FT, Hexner E, Mauro MJ, Sternberg DW, Villeneuve M, Huntsman Labed A, Stanek EJ, Hartmann K, Horny HP, Valent P, Reiter A. Efficacy and Safety of Midostaurin in Advanced Systemic Mastocytosis. N Engl J Med. 2016 Jun 30;374(26):2530-41. doi: 10.1056/NEJMoa1513098.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Poland
United Kingdom
Austria
Australia
Netherlands
Canada
United States
France
Turkey
Belgium
Norway
Germany

location_facility: Dana Farber Cancer Institute Hematology / Oncology

location_facility: University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(3)

location_facility: Oregon Health and Science University Dept. Hematologic Malignancies

location_facility: University of California at Los Angeles Dept. of Hematology Clinic

location_facility: Stanford University Medical Center Stanford University 2

location_facility: Georgia Health Sciences University Dept.ofMedicalCollegeOfGeorgia

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)

summary: The purpose of this study was to determine the efficacy and safety of twice daily (bid) oral midostaurin in patients with Aggressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) with or without an Associated Hematological clonal Non-Mast cell lineage Disease (AHNMD).


title: Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

summary:
Primary Objective:

To evaluate the safety (acute effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of IB1001 in subjects with hemophilia B.

Key Secondary Objectives:

To evaluate the ability of IB1001 to provide coverage against bleeding under surgical circumstances; To evaluate the long-term safety and efficacy of IB1001

ReferenceCitation: Collins PW, Quon DVK, Makris M, Chowdary P, Kempton CL, Apte SJ, Ramanan MV, Hay CRM, Drobic B, Hua Y, Babinchak TJ, Gomperts ED. Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated haemophilia B patients. Haemophilia. 2018 Jan;24(1):104-112. doi: 10.1111/hae.13324. Epub 2017 Aug 17.

ReferenceCitation: Martinowitz U, Shapiro A, Quon DV, Escobar M, Kempton C, Collins PW, Chowdary P, Makris M, Mannucci PM, Morfini M, Valentino LA, Gomperts E, Lee M. Pharmacokinetic properties of IB1001, an investigational recombinant factor IX, in patients with haemophilia B: repeat pharmacokinetic evaluation and sialylation analysis. Haemophilia. 2012 Nov;18(6):881-7. doi: 10.1111/j.1365-2516.2012.02897.x. Epub 2012 Jul 5.

lead_sponsor: Medexus Pharma, Inc.

location_country:
Poland
United Kingdom
Italy
India
United States
Israel
France

location_facility: Centre Regional de Traitement de l 'Hemophilie

location_facility: Manchester Haemophilia Comprehensive Care Manchester Royal Infirmary

location_facility: The Hemophilia Treatment Center of Orthopaedic Hospital

location_facility: University of Texas Health Science Center-Houston, Gulf States Hemophilia & Thrombophilia Center

location_facility: University Hospital of Wales Health Park

location_facility: Emory University School of Medicine Pediatric Hematology

location_facility: Centre for Haemostasis and Thrombosis, Basingstoke and North Hampshire Foundation Trust

location_facility: Hemophilia Treatment Center of Las Vegas

location_facility: Sahyadri Specialty Hospital, Deccan Gymkhana

location_facility: University of Minnesota Center for Bleeding and Clotting Disorder

location_facility: Rush University Medical Center-Pediatric Hematology Oncology


title: An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

location_country:
Spain
Italy
Australia
Canada
Sweden
Hungary
United States
France
Belgium
Germany
Czechia

summary: The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.


acronym: COMPLEMENT 1

title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia

ReferenceCitation: Tausch E, Beck P, Schlenk RF, Jebaraj BJ, Dolnik A, Yosifov DY, Hillmen P, Offner F, Janssens A, Babu GK, Grosicki S, Mayer J, Panagiotidis P, McKeown A, Gupta IV, Skorupa A, Pallaud C, Bullinger L, Mertens D, Döhner H, Stilgenbauer S. Prognostic and predictive role of gene mutations in chronic lymphocytic leukemia: results from the pivotal phase III study COMPLEMENT1. Haematologica. 2020 Oct 1;105(10):2440-2447. doi: 10.3324/haematol.2019.229161.

ReferenceCitation: Hillmen P, Robak T, Janssens A, Babu KG, Kloczko J, Grosicki S, Doubek M, Panagiotidis P, Kimby E, Schuh A, Pettitt AR, Boyd T, Montillo M, Gupta IV, Wright O, Dixon I, Carey JL, Chang CN, Lisby S, McKeown A, Offner F; COMPLEMENT 1 Study Investigators. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015 May 9;385(9980):1873-83. doi: 10.1016/S0140-6736(15)60027-7. Epub 2015 Apr 14.

ReferenceCitation: Jewell RC, Laubscher K, Lewis E, Fang L, Gafoor Z, Carey J, McKeown A, West S, Wright O, Sedoti D, Dixon I, Hottenstein CS, Chan G. Assessment of the effect of ofatumumab on cardiac repolarization. J Clin Pharmacol. 2015 Jan;55(1):114-21. doi: 10.1002/jcph.376. Epub 2014 Aug 21.

location_country:
Poland
Brazil
Spain
Greece
Ireland
Italy
Netherlands
Canada
Russian Federation
United Kingdom
Sweden
United States
France
India
Belgium
Germany
Czechia

summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.


title: A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas

acronym: PEARLII

summary: This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

ReferenceCitation: Donnez J, Tomaszewski J, Vázquez F, Bouchard P, Lemieszczuk B, Baró F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.

lead_sponsor: PregLem SA

location_country: Poland Spain Italy Austria Netherlands France Israel Belgium Germany

location_facility: Hopital Erasme, Department of Obstetrics and Gynecology,

location_facility: Soroka University Medical Center, Division of Obstetrics & Gynecology

location_facility: Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena

location_facility: Hadassah University Hospital, Mount Scopus

location_facility: Universita di Padova-Dip scienze ginecologiche e della riproduzione umana

location_facility: Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology

location_facility: Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,

location_facility: Rabin Medical Center, Helen Schneider Hospital for Women

location_facility: Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari

location_facility: CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique

location_facility: Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii

location_facility: University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine

location_facility: Policlinico Universitario "Agostino Gemelli"

location_facility: Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari

location_facility: Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone

location_facility: Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe

location_facility: Poliklinik fur Frauenheilkunde und Geburtshilfe

location_facility: Gabinet Lekarski Specjalistyczny "Sonus"

location_facility: Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia


title: A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Activity of GS 9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)

summary: The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH).

lead_sponsor: Gilead Sciences

location_country:
United States
France