title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)

acronym: FSHD

summary: This is a study to evaluate the safety and efficacy of Losmapimod in treating patients with Facioscapulohumeral Muscular Dystrophy (FSHD) over 48 weeks.

ReferenceCitation: Barbour AM, Sarov-Blat L, Cai G, Fossler MJ, Sprecher DL, Graggaber J, McGeoch AT, Maison J, Cheriyan J. Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers. Br J Clin Pharmacol. 2013 Jul;76(1):99-106. doi: 10.1111/bcp.12063.

ReferenceCitation: Cheriyan J, Webb AJ, Sarov-Blat L, Elkhawad M, Wallace SM, Maki-Petaja KM, Collier DJ, Morgan J, Fang Z, Willette RN, Lepore JJ, Cockcroft JR, Sprecher DL, Wilkinson IB. Inhibition of p38 mitogen-activated protein kinase improves nitric oxide-mediated vasodilatation and reduces inflammation in hypercholesterolemia. Circulation. 2011 Feb 8;123(5):515-23. doi: 10.1161/CIRCULATIONAHA.110.971986. Epub 2011 Jan 24.

ReferenceCitation: de Greef JC, Lemmers RJ, van Engelen BG, Sacconi S, Venance SL, Frants RR, Tawil R, van der Maarel SM. Common epigenetic changes of D4Z4 in contraction-dependent and contraction-independent FSHD. Hum Mutat. 2009 Oct;30(10):1449-59. doi: 10.1002/humu.21091.

ReferenceCitation: Han JJ, Kurillo G, Abresch RT, de Bie E, Nicorici A, Bajcsy R. Reachable workspace in facioscapulohumeral muscular dystrophy (FSHD) by Kinect. Muscle Nerve. 2015 Feb;51(2):168-75. doi: 10.1002/mus.24287. Epub 2014 Nov 19.

ReferenceCitation: Jagannathan S, Shadle SC, Resnick R, Snider L, Tawil RN, van der Maarel SM, Bradley RK, Tapscott SJ. Model systems of DUX4 expression recapitulate the transcriptional profile of FSHD cells. Hum Mol Genet. 2016 Oct 15;25(20):4419-4431. doi: 10.1093/hmg/ddw271.

ReferenceCitation: Statland JM, Tawil R. Risk of functional impairment in Facioscapulohumeral muscular dystrophy. Muscle Nerve. 2014 Apr;49(4):520-7. doi: 10.1002/mus.23949. Epub 2014 Feb 10.

ReferenceCitation: Wang LH, Friedman SD, Shaw D, Snider L, Wong CJ, Budech CB, Poliachik SL, Gove NE, Lewis LM, Campbell AE, Lemmers RJFL, Maarel SM, Tapscott SJ, Tawil RN. MRI-informed muscle biopsies correlate MRI with pathology and DUX4 target gene expression in FSHD. Hum Mol Genet. 2019 Feb 1;28(3):476-486. doi: 10.1093/hmg/ddy364.

ReferenceCitation: Jagannathan S, de Greef JC, Hayward LJ, Yokomori K, Gabellini D, Mul K, Sacconi S, Arjomand J, Kinoshita J, Harper SQ. Meeting report: the 2021 FSHD International Research Congress. Skelet Muscle. 2022 Jan 17;12(1):1. doi: 10.1186/s13395-022-00287-8.

repository_institution: Radboud University - Radboud Repository

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

evidence: oa repository (via OAI-PMH title and last author match)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: Leiden University - Leiden Repository

repositories_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

lead_sponsor: Fulcrum Therapeutics

location_country:
United States
Spain
Canada
France

location_facility: University of California Los Angeles (UCLA)

location_facility: Montreal Neurological Institute and Hospital

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Washington University School of Medicine


type: EudraCT Number

type: Other Identifier

title: An Open-label, First-in-human, Single Agent, Dose-escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

summary:
Primary Objectives:

Dose Escalation Part A: To determine the maximum tolerated dose (MTD) of SAR442085 administered as a single agent in patients with relapsed or refractory multiple myeloma (RRMM), and determine the recommended Phase 2 dose (RP2D) for the subsequent Expansion Part B
Dose Expansion Part B: To assess the antitumor activity of single agent of SAR442085 at the RP2D in patients with RRMM

Secondary Objectives:

To characterize the safety profile of SAR442085
To characterize the pharmacokinetics (PK) profile of SAR442085 when administered as a single agent
To evaluate the potential immunogenicity of SAR442085
To assess preliminary evidence of antitumor activity in the Dose Escalation Part A

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
United States
Spain
Greece
Taiwan
Czechia
France

location_facility:
Investigational Site Number :8400006
Investigational Site Number :7240001
Investigational Site Number :8400005
Investigational Site Number :1580001
Investigational Site Number :8400002
Investigational Site Number :2030002
Investigational Site Number :2500001
Investigational Site Number :2030003
Investigational Site Number :3000001
Investigational Site Number :8400003
Investigational Site Number :1580002
Investigational Site Number :2030001
Investigational Site Number :8400004
Investigational Site Number :7240002

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis

summary:
Primary Objective:

To determine the long-term safety and tolerability of SAR442168 in RMS participants

Secondary Objective:

To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

status: Active, not recruiting

study_completion_date_type: Anticipated

location_country:
Netherlands
United States
Spain
Czechia
Ukraine
Canada
Estonia
Russian Federation
France

location_facility:
Investigational Site Number 2030003
Investigational Site Number 7240001
Investigational Site Number 8400003
Investigational Site Number 8040002
Investigational Site Number 8400006
Investigational Site Number 8040006
Investigational Site Number 7240005
Investigational Site Number 1240001
Investigational Site Number 8040009
Investigational Site Number 8400007
Investigational Site Number 2030007
Investigational Site Number 8400008
Investigational Site Number 2030001
Investigational Site Number 2030002
Investigational Site Number 8040003
Investigational Site Number 6430007
Investigational Site Number 6430001
Investigational Site Number 8400009
Investigational Site Number 8040007
Investigational Site Number 2030006
Investigational Site Number 8040001
Investigational Site Number 7240003
Investigational Site Number 2500004
Investigational Site Number 8400005
Investigational Site Number 7240004
Investigational Site Number 5280001
Investigational Site Number 6430006
Investigational Site Number 2030004
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 2330001
Investigational Site Number 7240002
Investigational Site Number 2030005
Investigational Site Number 8040005
Investigational Site Number 6430005
Investigational Site Number 6430003
Investigational Site Number 1240003

status_simplified: Ongoing


title: A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs

acronym: contRAst 2

summary: This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

design_allocation: Randomized

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Iqvia Pty Ltd

location_country:
Germany
Poland
Colombia
Hungary
Argentina
United Kingdom
Australia
Japan
Mexico
United States
China
Korea, Republic of
Spain
Thailand
Bulgaria
Estonia
Russian Federation
France


lead_sponsor: Novartis Pharmaceuticals

summary: This Phase II is a multicenter, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to hypomethylating agents (azacitidine or decitabine) in adult subjects with IPSS-R intermediate, high or very high risk myelodysplastic syndrome (MDS) not eligible for Hematopoietic Stem Cell Transplant (HSCT) or intensive chemotherapy.

location_facility: Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology

location_facility: City of Hope National Medical Center Medical Oncology & Therapeutic

location_facility: The Cancer Institute of New Jersey The Cancer Institute of NJ

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC BCL201X2102C

title: A Randomized, Double-blind, Placebo-controlled Phase II Multi-center Study of Intravenous MBG453 Added to Hypomethylating Agents in Adult Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R Criteria

primary_purpose: Supportive Care

source: euctr

location_country:
Germany
Italy
Hungary
Hong Kong
United Kingdom
Japan
Austria
Belgium
United States
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Czechia
Canada
France


title: A pilot study to test the feasibility, safety and efficacy of the addition of the BiTE antibody Blinatumomab to the Interfant-06 backbone in infants with MLL-rearranged acute lymphoblastic leukemia. A collaborative study of the Interfant network.

lead_sponsor: Princess Máxima Center for Pediatric Oncology

status: Ongoing


title: A prospective randomised phase III study of androgen deprivation therapy with or without local  radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.

lead_sponsor: UNICANCER


title: IDH mutated 1p/19q intact lower grade glioma following resection: Wait Or Treat? IWOT – A phase III study

acronym: IWOT

lead_sponsor: European Organisation for Research and Treatment of Cancer

status: Prematurely Ended


title:
A Randomized Phase 3 Comparison of IMO-2125 with Ipilimumab versus Ipilimumab Alone in Subjects with Anti-PD-1 Refractory Melanoma

 Étude randomisée de phase III visant à comparer l’association IMO-2125 et ipilimumab versus ipilimumab seul chez des sujets présentant un mélanome réfractaire aux anticorps anti-PD-1

lead_sponsor: Idera Pharmaceuticals, Inc.


title: A Phase 3, Randomised, Placebo-Controlled Trial of Arimoclomol in Amyotrophic Lateral Sclerosis

lead_sponsor: Orphazyme A/S

status: Completed

status_simplified: Completed


title: A Phase II Open Label Study of MK-7009 Administered Concomitantly with Pegylated Interferon Alfa-2a and Ribavirin to Patients with Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials

lead_sponsor: Merck & Co., Inc.


title: A Phase 2, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Standard of Care in Subjects with Previously Untreated and Advanced (unresectable or metastatic) non-clear Cell Renal Cell Carcinoma

acronym: SUNNIFORECAST

lead_sponsor: Goethe University Frankfurt

lead_sponsor_type: academique


title:
PHASE 1B/PHASE 3 MULTICENTER STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION REGIMENS THAT INCLUDE AN IMMUNE AGONIST, EPIGENETIC MODULATOR, CD20 ANTAGONIST AND/OR CONVENTIONAL CHEMOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)

 ÉTUDE DE PHASE IB/III MULTICENTRIQUE PORTANT SUR L’AVÉLUMAB (MSB0010718C) DANS DES ASSOCIATIONS THÉRAPEUTIQUES INCLUANT UN AGONISTE IMMUNITAIRE, UN MODULATEUR ÉPIGÉNÉTIQUE, UN ANTAGONISTE DE CD20 ET/OU UNE CHIMIOTHÉRAPIE CLASSIQUE CHEZ DES PATIENTS ATTEINTS DE LYMPHOME DIFFUS À GRANDES CELLULES B (LDGCB) RÉCIDIVANT OU RÉFRACTAIRE

acronym: JAVELIN DLBCL

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


title: Risk stratified randomized controlled trial in paediatric Crohn’s Disease: Methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or at high risk for aggressive disease course, respectively – a treatment strategy

acronym: REDUCE-RISKincd-PIBD-TRIAL

lead_sponsor: PIBDNet


title:
An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10

 Etude exploratoire de maintenance évaluant l’effet du BI 655064 chez des patients atteints de néphropathie lupique et ayant présenté une réponse significative soit à la fin de l’étude 1293.10 soit après un traitement d’induction en dehors de l’étude 1293.10

lead_sponsor: Boehringer Ingelheim France


title:
Corticosteroids or clobazam for ESES syndrome: a European, multicenter,
 randomized, controlled clinical trial

acronym: RESCUE ESES: Randomized European trial of Steroids vs Clobazam Usage

lead_sponsor: University Medical Center Utrecht


title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib or Nivolumab and Ipilimumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

lead_sponsor: Bristol-Myers Squibb International Corporation


title:
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy

 Étude de phase 2, randomisée, en double aveugle, contrôlée contre placebo, évaluant la sécurité et l’efficacité de l’Avacopan (CCX168) chez des patients atteints de glomérulopathie à C3

lead_sponsor: ChemoCentryx, Inc.


title: A 52 week, randomised, double blind, multinational, multicentre, 4-arm parallel group trial to assess the efficacy and safety of 3 doses of CHF 6532 (10, 25 or 50 mg BID) compared to placebo on top of standard of care in subjects with uncontrolled severe eosinophilic asthma.

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: A European randomised Phase 3 study to assess the efficacy and safety of TOOKAD® Soluble for low risk localised prostate cancer compared to Active Surveillance

lead_sponsor: STEBA BIOTECH SA


title: Phase IIIb randomized trial comparing irradiation plus long term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG. Pegasus

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


title: A Phase 3 Randomized, Open-Label Clinical Study to Evaluate the Efficacy and Safety of Pembrolizumab plus Epacadostat, Pembrolizumab Monotherapy, and the EXTREME Regimen as First line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-669/ECHO-304)

acronym: Pembrolizumab plus epacadostat, and the EXTREME regimen as first line tre for R/M HNSCC

lead_sponsor: Incyte Corporation


title: A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel plus a Reduced Dose of Capecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated with a Taxane

acronym: CONTESSA

lead_sponsor: Odonate Therapeutics, LLC


title: A Phase III Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects with Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-240)

acronym: Phase III Study of MK 3475 + Best Supportive Care in Subjects with Advanced Hepatocellular Carcinoma

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


title: A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

acronym: EaseSBS 2 - Efficacy And Safety Evaluation of Glepaglutide in treatment of SBS

lead_sponsor: Zealand Pharma A/S


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Sublimity Therapeutics (Hold Co) Ltd.


title: A Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome

acronym: PATIDEGIB study

lead_sponsor: PellePharm, Inc.


title: Multi-center, double-blind, randomized, placebo-controlled, phase IIa trial to evaluate spesolimab (BI 655130) efficacy in patients with fibrostenotic Crohn’s Disease


title: A Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group, Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute Kidney Injury

lead_sponsor: AM-Pharma B.V.


title:
A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared with PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected with Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)ide Therapy (D-LIVR)

 Étude randomisée de phase III, avec un plan matriciel et partiellement en double aveugle, visant à évaluer l’efficacité et la sécurité d’emploi de 50 mg de lonafarnib et 100 mg de ritonavir administrés deux fois par jour pendant 48 semaines, associés ou non à 180 µg de peginterféron alfa-2a, en comparaison avec une monothérapie de peginterféron alfa-2a et un traitement par placebo chez des patients présentant une infection chronique par le virus de l’hépatite D et recevant un traitement d’entretien par nucléoside(tide) anti-VHB (Virus de l’hépatite B) (D-LIVR)

acronym: D-LIVR

lead_sponsor: Eiger BioPharmaceuticals, Inc.


title: A Randomized Open-Label Phase III Trial of MK-3475 versus Platinum based Chemotherapy in 1L Subjects with PD-L1 Strong Metastatic Non-Small Cell Lung Cancer

acronym: MK-3475 versus SOC in 1L Subjects with PD-L1 Strong Metastatic NSCLC


title: ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

acronym: ASSURE

lead_sponsor: CymaBay Therapeutics, Inc.


title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (FASLODEX) with or without PD-0332991 (PALBOCICLIB) ± Goserelin in Women with Hormone Receptor-Positive, Her2-Negative Metastatic Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy

lead_sponsor: Pfizer Inc 235 East 42nd Street, New York, NY10017


title: Feasibility of the Multiple Sclerosis Performance Test for Assessment of Functional Performance Measures in Patients With Multiple Sclerosis

summary: The primary objective is to evaluate the feasibility of the Multiple Sclerosis Performance Test (MSPT) in a clinical care setting when used by participants with Multiple Sclerosis (MS).

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

lead_sponsor: Biogen

location_country:
Italy
United Kingdom
Switzerland
United States
Czechia
France

intervention_type: Other


title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants

lead_sponsor: Incyte Biosciences International Sàrl


title: A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment of Clostridium difficile infection (CDI).

lead_sponsor: Summit (Oxford) Limited


title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS)

 Essai multicentrique de phase III, randomisé, en double aveugle, contre placebo, visant à évaluer la tolérance et l’efficacité de l’AMX0035 par rapport à un placebo, dans le traitement de patients adultes atteints de Sclérose Latérale Amyotrophique (SLA) sur une période de 48 semaines.

acronym: Phoenix

lead_sponsor: Amylyx Pharmaceuticals Inc.


title: Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis

acronym: ADAPT JR

lead_sponsor: argenx BV


title:
A Long-term, Single-Arm, Open-label, Multicenter, Follow-on Trial of ARGX113-2006 to Evaluate Safety of Efgartigimod Administered Intravenously in
 Children With Generalized Myasthenia Gravis

acronym: ADAPT JR.+


title: A Post-Market Study Evaluating the Safety of Infinity DBS System With MR Conditional Labeling

summary: This is a study of subjects with the St. Jude Medical Infinity deep brain stimulation (DBS) system who undergo an MRI imaging procedure. Enrollment may occur before DBS implant, or when an MRI scan is planned in a subject with an existing implant. There will be a follow-up visit one month after the MRI procedure to document any adverse events and verify device functionality.

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

location_country:
Germany
France
United States
Spain
Sweden

location_facility: Wright State University & Premier Health

location_facility: Banner University Medical Center Tucson Campus

location_facility: Medizinische Einrichtungen der Universität Düsseldorf

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

intervention_type: Device


title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)

lead_sponsor: Amgen Inc.


title: Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites

acronym: PRECIOSA

lead_sponsor: Instituto Grifols S.A.


acronym: CASSIOPEIA

intervention_type: Biological

lead_sponsor: Novartis Pharmaceuticals

summary: This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment & follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.

ReferenceType: derived

ReferenceCitation: Seftel MD. Hyper-CVAD: a regimen for all seasons. Lancet Haematol. 2020 Jul;7(7):e501-e502. doi: 10.1016/S2352-3026(20)30179-4. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

sponsor_collaborators:
Novartis Pharmaceuticals
Children's Oncology Group

location_facility: The Childrens Hospital of Philadelphia Div Gastroint., Hepat. & Nutr.

location_facility: Childrens Hospital Los Angeles SC CTL019

location_facility: Roswell Park Cancer Institute Main Centre

location_facility: University of Mississippi Medical Center Childrens Hospital .

location_facility: Children's Hospital of Richmond at VCU Pediatric Hematology Oncology

location_facility: University of Wisconsin Hospital and Clinics Pharmacy/Drug Shipping Address

location_facility: Children's Healthcare of Atlanta Emory University IRB

location_facility: University of Utah Clinical Trials Office .

location_facility: Texas Children's Cancer and Hematology Center

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago .

location_facility: Dana Farber Cancer Institute Dept.of DFCI

location_facility: James Whitcomb Riley Hospital for Children

location_facility: Johns Hopkins Oncology Center Cancer Research Building

location_facility: Univ Hospital - Cleveland/Rainbow Babies and Children's Hosp Pediatric Nephrology

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: Children's Hospital of Orange County CHOC Children's

location_facility: Medical Uni of South Carolina Medical Univ of SC

location_facility: Cohen Children's Medical Center of New York

location_facility: Monroe Carell Jr Childrens Hospital at Vanderbilt

location_facility: University of Texas Southwestern Medical Center

location_facility: St. Louis University/Cardinal Glennon Children's Hospital

location_facility: Columbia University Medical Center Oncology

location_facility: Washington University School of Medicine CTBM100C2412

status: Recruiting

title: A Phase II Trial of Tisagenlecleucel in First-line High-risk (HR) Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL) Who Are Minimal Residual Disease (MRD) Positive at the End of Consolidation (EOC) Therapy

enrollment_type: Anticipated

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Canada
France


title: A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.

acronym: The APOLLO Study

lead_sponsor: European Myeloma Network (EMN)


title: ACHieve: A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia

summary: This is a long-term, multi-center, longitudinal, observational study in children with achondroplasia (ACH). The aim is to study height velocity and comorbidities in children with ACH. This is a natural history study and no study medication will be administered.

lead_sponsor: Ascendis Pharma A/S

location_country:
Germany
Ireland
Italy
Portugal
New Zealand
United Kingdom
Denmark
Australia
Switzerland
Austria
United States
China
Spain
Canada
France


title: Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality

acronym: APACHE


title: A phase 3, open-label, randomized, multicenter, 12 months, efficacy and safety study of weekly mod-4023 compared to daily genotropin® therapy in pre-pubertal children with growth hormone deficiency

lead_sponsor: OPKO Biologics Ltd.


title:
A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Subjects with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

 Étude de phase 3, contrôlée, randomisée, en double aveugle, portant sur le cabozantinib en association au nivolumab et l’ipilimumab par rapport au nivolumab et à l’ipilimumab chez des patients présentant un carcinome à cellules rénales avancé ou métastatique non traité auparavant, à risque intermédiaire ou faible

lead_sponsor: Exelixis, Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA)

acronym: JUVE-BALM

lead_sponsor: Eli Lilly and Company


title: A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

acronym: TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for NSCLC With EGFR Exon 20 Inser

lead_sponsor: Millennium Pharmaceuticals, Inc. Millennium Pharmaceuticals is a wholly owned subsidiary of Takeda Pharmaceutical


title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects ≥ 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation

lead_sponsor: Agios Pharmaceuticals, Inc.


title: An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

acronym: PHYOX 3

lead_sponsor: Dicerna Pharmaceuticals Inc


title: A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Celltrion, Inc.


title: A Phase 3b/4 Randomized, Double-blind, Dose-Flexibility Study of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis (Flex-Up)

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title: An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial


title: A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma

lead_sponsor: Incyte Corporation


title: A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)

acronym: COURAGE-ALS OLE

lead_sponsor: Cytokinetics Inc


title: Trial consisting of an 8-week double-blind placebo-controlled part to evaluate efficacy, safety, tolerability and pharmacokinetics of prucalopride in paediatric subjects with functional constipation, aged ≥6 months to <18 years, followed by a 16-week open-label comparator (PEG) controlled part, to document safety and tolerability up to 24 weeks

acronym: Not applicable

lead_sponsor: Shire-Movetis NV


title: A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor.


title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD)

lead_sponsor: Albireo AB


title: A Phase 3 multicenter, randomized, double-blind, placebo-controlled, clinical study to assess the efficacy and safety of linzagolix in subjects with moderate to severe endometriosis-associated pain.

acronym: Edelweiss 3

lead_sponsor: ObsEva S.A.


title:
A Phase 3, Open-Label, Multicenter Study of ALXN1210 in Children and Adolescents with Atypical Hemolytic Uremic Syndrome (aHUS)

 Étude de phase III, en ouvert, multicentrique, évaluant l’ALXN1210 chez des enfants et des adolescents atteints du syndrome hémolytique et urémique atypique (SHUa)

lead_sponsor: Alexion Pharmaceuticals Incorporated


title: A prospective, multicenter, randomised, open-label, active-controlled, two-parallel groups, phase 3 study to compare the efficacy and safety of masitinib to sunitinib in patients with gastrointestinal stromal tumor resistant to imatinib

lead_sponsor: AB Science


title: Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF).

lead_sponsor: FibroGen, Inc.


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

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

lead_sponsor: MeiraGTx UK II Limited


title: A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel-group Study to Assess the Time to Response to Lisdexamfetamine Dimesylate and Atomoxetine Hydrochloride in Children and Adolescents aged 6-17 years with Attention Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy.

lead_sponsor: Shire Pharmaceutical Development Ltd.


title: MRX-503: An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis (PFIC)

lead_sponsor: Mirum Pharmaceuticals Inc.


title: OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS

summary: To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.

lead_sponsor: TransMedics

location_country:
Germany
Italy
United Kingdom
Australia
Belgium
United States
Spain
Canada
France

location_facility: University of California at San Francisco

location_facility: St. Joseph's Hospital and Medical Center


title:
A MULTICENTER, OPEN-LABEL, LONG-TERM SAFETY STUDY OF AR101 CHARACTERIZED ORAL DESENSITIZATION IMMUNOTHERAPY IN SUBJECTS WHO PARTICIPATED IN A PRIOR AR101 STUDY

 Étude multicentrique, en ouvert et à long terme portant sur la sécurité d’emploi de l’AR101, une immunothérapie de désensibilisation spécifique par voie orale, chez des patients ayant participé à une étude antérieure sur l’AR101

acronym:
Long-term Safety Study of AR101 CODIT™

 Étude de sécurité à long terme sur l’AR101 CODIT™

lead_sponsor: Aimmune Therapeutics, Inc.


title: A phase I/II study of Bosutinib in pediatric patients with Chronic Myeloid Leukemia who are resistant or intolerant to at least one prior Tyrosine Kinase Inhibitor therapy, ITCC-054/AAML1621

acronym: Bosutinib in pediatric CML

lead_sponsor: Erasmus MC


title: Rostock International Parkinson's Disease Study: an International, Multicenter, Epidemiological Observational Study

acronym: ROPAD

summary: Rostock International Parkinson's Disease Study - An International, multicenter, epidemiological observational study aiming at identification of LRRK2-positive patients, the recruitment of 25,000 PD participants and the establishment of a candidate biomarker in the LRRK2-positive cohort.

ReferenceType: result

ReferenceCitation: Baumann CR. Epidemiology, diagnosis and differential diagnosis in Parkinson's disease tremor. Parkinsonism Relat Disord. 2012 Jan;18 Suppl 1:S90-2. doi: 10.1016/S1353-8020(11)70029-3.

ipd_sharing_description: The plan will be defined at a later stages

lead_sponsor: CENTOGENE GmbH Rostock

location_country:
Germany
Italy
Albania
Portugal
Israel
Norway
United Kingdom
Brazil
Belgium
United States
Spain
Greece
Turkey
Canada
France

location_facility: AOUP Secondo Policlinico Federico II Napoli

location_facility: Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson

location_facility: Michigan Institute for Neurological Disorders

location_facility: HM CINAC | Integrated Neuroscience Center

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: Parkinson's Disease and Movement Disorder Center of Baco Raton

location_facility: Hospital Universitario Pedro Ernesto (HUPE)

location_facility: University of Oxford, Nuffield Department of Clinical Neurosciences

location_facility: Hospital das Clínicas da Universidade Federal de Minas Gerais

location_facility: Centro Hospitalar Universitário de São João

location_facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein

location_facility: Hospital Universitário Walter Cândido/ Universidade Federal do Ceará

location_facility: Universitätsklinikum Carl Gustav Carus die Dresdner

location_facility: Toronto Western Hospital, University Health Network, University of Toronto

location_facility: Hospital General Unversitario Gregorio Marañón

location_facility: Universidade Federal de São Paulo, UNIFESP

location_facility: Department of Neurology, Centre Hospitalier Universitaire (CHU) de Leige

location_facility: Vero Beach Neurology & Research Institute

location_facility: Royal Preston Hospital, Department of Neurology

location_facility: Federal University of Health Science of Porto Alegre

location_facility: Neurology Department, Hospital de Santa Maria

location_facility: Faculdade de Medicina de Ribeirão Preto - USP

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Newcastle University, Clinical Ageing Research Unit

location_facility: Tel Aviv Sourasky Medical Center - TASMC

location_facility: Asklepios Fachklinikum Stadtroda Klinik für Neurologie, Schmerztherapie und Schlafmedizin

location_facility: Universitätsklinikum Marburg Klinik und Poliklinik für Neurologie Parkinson Netzwerk Allianz Marburg (PANAMA)

location_facility: Università di Pavia, Dipartimento di Medicina Molecolare

location_facility: University Hospital Marqués de Valdecilla

location_facility: Indiana University, Department of Neurology

location_facility: Duke University, Department of Neurology

location_facility: Stony Brook University School of Medicine

location_facility: Clinica de Neurocirurgia E Neurofisiologia Ltda

location_facility: Universitätsklinikum Schleswig-Holstein, Klinik für Neurologie


title: REtroperitoneal SArcoma Registry (RESAR): Prospective Collection of Primary Retroperitoneal Sarcoma Patient's Data, Radiological and Pathological Material for the TransAtlantic Retroperitoneal Sarcoma Working Group

acronym: RESAR

summary:
Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority.

Primary Objectives of this study are:

to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers.
patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).

Secondary Objectives:

to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS;
to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy;
to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease;
to utilize collected pathological material for research collaborations.

ReferenceType: background

ReferenceCitation: Gronchi A, Strauss DC, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Raut CP. Variability in Patterns of Recurrence After Resection of Primary Retroperitoneal Sarcoma (RPS): A Report on 1007 Patients From the Multi-institutional Collaborative RPS Working Group. Ann Surg. 2016 May;263(5):1002-9. doi: 10.1097/SLA.0000000000001447.

ReferenceCitation: Trans-Atlantic RPS Working Group. Management of primary retroperitoneal sarcoma (RPS) in the adult: a consensus approach from the Trans-Atlantic RPS Working Group. Ann Surg Oncol. 2015 Jan;22(1):256-63. doi: 10.1245/s10434-014-3965-2. Epub 2014 Oct 15.

ReferenceCitation: MacNeill AJ, Gronchi A, Miceli R, Bonvalot S, Swallow CJ, Hohenberger P, Van Coevorden F, Rutkowski P, Callegaro D, Hayes AJ, Honore C, Fairweather M, Cannell A, Jakob J, Haas RL, Szacht M, Fiore M, Casali PG, Pollock RE, Barretta F, Raut CP, Strauss DC. Postoperative Morbidity After Radical Resection of Primary Retroperitoneal Sarcoma: A Report From the Transatlantic RPS Working Group. Ann Surg. 2018 May;267(5):959-964. doi: 10.1097/SLA.0000000000002250.

ipd_sharing: Undecided

lead_sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

location_country:
Germany
Italy
Poland
Slovenia
United Kingdom
Australia
United States
Korea, Republic of
Spain
Canada
France

location_facility: Hospital Clinico Universitario "Virgen de la Arrixaca"

location_facility: University Hospital Birmingham (Queen Elizabeth)

location_facility: Maisonneuve-Rosemont Hospital / University of Montreal

location_facility: Brigham and Women's Hospital/Dana-Farber Cancer Institute

location_facility: University Medical Center and Medical Faculty Mannheim, University of Heidelberg

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology


title:
A Phase 3, Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with Systemic Corticosteroids in Subjects with Non-ambulatory Duchenne Muscular Dystrophy (DMD)

 Un essai de phase III, randomisé, en double aveugle portant sur le pamrevlumab (FG-3019) ou un placebo en association avec des corticostéroïdes systémiques chez des patients atteints de dystrophie musculaire de Duchenne (DMD) non ambulatoire


title: A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177)

acronym: A Phase III Study of Pembrolizumab vs. Chemotherapy in MSI-H or dMMR Stage IV Colorectal Carcinoma

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


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


title: International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukemia

acronym: INTERFANT 06

lead_sponsor: Dutch Childhood Oncology Group


title:
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

 Étude de phase 3, internationale, en double aveugle, randomisée, contrôlée par placebo portant sur le MGL 3196 (resmétirom) chez des patients atteints d’une stéatohépatite non alcoolique (Non-Alcoholic Steatohepatitis, NASH) avec fibrose hépatique visant à faire disparaître la NASH et à diminuer la progression vers une cirrhose et/ou une décompensation hépatique

lead_sponsor: Madrigal Pharmaceuticals, Inc.


title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY

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


title:
A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

 Étude de phase 3, contrôlée par placebo externe, ouverte, multicentrique, visant à évaluer l’efficacité et la sécurité du ravulizumab chez des patients adultes présentant un trouble du spectre de la neuromyélite optique (NMOSD)

acronym: A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD

lead_sponsor: Alexion Pharmaceuticals, Inc.


title:
A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)

 ÉTUDE EN DOUBLE AVEUGLE, CONTRÔLÉE CONTRE PLACEBO, VISANT À ÉVALUER L’EFFICACITÉ ET LA TOLERANCE D’UN TRAITEMENT DE 24 SEMAINES PAR REN001 CHEZ DES PATIENTS ATTEINTS DE MYOPATHIE MITOCHONDRIALE PRIMAIRE (MMP)

acronym: Phase 2b Safety and Efficacy Study of REN001 in Mitochondrial Myopathy

lead_sponsor: Reneo Pharma Ltd.


title: An open label, multicenter pasireotide roll over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatment

lead_sponsor: Novartis Pharma Services AG


title: A Randomized, Multi-center Phase III Study of Nivolumab versus Sorafenib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma

acronym: CheckMate 459

lead_sponsor: Bristol-Myers Squibb International Corporation


title: An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301

lead_sponsor: Calliditas Therapeutics AB


title:
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma

 Étude randomisée de phase III comparant une chimiothérapie néoadjuvante suivie d’une chirurgie et une chirurgie seule chez des patients atteints d’un sarcome rétropéritonéal à risque élevé

acronym: STRASS 2

lead_sponsor: European Organisation for Research and Treatment of Cancer


title:
An open-label extension trial to evaluate the long-term safety of apraglutide in short bowel syndrome

 Étude d’extension en ouvert visant à évaluer l’innocuité à long terme de l’apraglutide chez des patients présentant un syndrome du grêle court

lead_sponsor: VectivBio AG


title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study of Cemiplimab Versus the Combination of Cemiplimab With ISA101b in the Treatment of Subjects With HPV16-Positive Platin-Resistant Oropharyngeal Cancer (OPC)

lead_sponsor: ISA Therapeutics B.V.


title: Phase II randomised, double blind, multicentre study to assess the efficacy of AZD2281 in the treatment of patients with platinum sensitive serous ovarian cancer following treatment with two or more platinum containing regimens

lead_sponsor: AstraZeneca AB


title: A Global, Multicenter, Randomized, Placebo-Controlled Phase 3 Trial to Compare the Efficacy and Safety of Fruquintinib Plus Best Supportive Care to Placebo Plus Best Supportive Care in Patients with Refractory Metastatic Colorectal Cancer (FRESCO-2)

acronym: Refer to the protocol

lead_sponsor: Hutchison MediPharma Limited


title: A Phase III Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy


title:
An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE)

 Étude d’extension au long cours, en ouvert, du brazikumab chez des patients présentant une maladie de Crohn active, modérée à sévère (INTREPID OLE)


title:
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn’s Disease (MACARONI-23)

 Étude « plateforme » de phase III, multicentrique, randomisée, portant sur l’inhibition de la voie IL-23 par p19 afin d’établir son efficacité dans la maladie de Crohn pédiatrique

lead_sponsor: Janssen-Cilag International NV


title: A Phase 2a, Randomized, Double-blind, Placebo controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Belcesiran in Patients with PiZZ Alpha-1 Antitrypsin Deficiency

lead_sponsor: Dicerna Pharmaceuticals, Inc.


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)

lead_sponsor: Principia Biopharma, Inc.


title: French African Pediatric Oncology Registry

acronym: RFAOP

summary:
The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group. This data will help to plan and provide correct pediatric oncology treatment and care for this population.

Collecting the data will give much needed information on numbers, stage, treatment and outcome. The register will give data for local and national health authorities in planning pediatric cancer programs.

ipd_sharing_description: Units have acess to their own data and can use it for reporting.

lead_sponsor: French Africa Pediatric Oncology Group

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Togo
Congo, The Democratic Republic of the
Burkina Faso
Côte D'Ivoire
Mali
Gabon
Senegal
Madagascar
Niger
Mauritania
Cameroon
France

location_facility: Centre Mère et Enfant CME-FCB (Fondation Chantal Biya)

location_facility: CNLC, Centre National de Lutte contre le Cancer

location_facility: Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle

location_facility: l'Institut de Cancérologie de Libreville

location_facility: HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona

location_facility: Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001

location_facility: Cliniques Universitaires de Lubumbashi (CUL)


title:
An open-label, multi-center, roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat

 Etude multicentrique, en ouvert et de poursuite du traitement afin d’évaluer la tolérance à long terme chez des patients atteints du syndrome de Cushing endogène ayant terminé une précédente étude Novartis portant sur l’osilodrostat (LCI699) et continuant à bénéficier du traitement par osilodrostat selon leur médecin-investigateur

lead_sponsor: Novartis Pharma AG


title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager Acapatamab in Subjects With Metastatic Castration-resistant Prostate Cancer

summary: A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of prostate specific membrane antigen half-life extended bispecific T-cell engager acapatamab in subjects with metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Singapore
Australia
Japan
Netherlands
Austria
Belgium
United States
Taiwan
Canada
France

location_facility: Krankenhaus der Barmherzigen Brueder Wien

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Texas Southwestern Medical Center

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc


title: A double-blind randomized extension study to assess the long-term efficacy and safety of linzagolix in subjects with endometriosis-associated pain.

acronym: Edelweiss 3 extension

lead_sponsor: ObsEva S.A.


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

summary: The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Germany
Poland
Argentina
Japan
Thailand
Turkey
Croatia
Czechia
Canada
France
Portugal
Hungary
Switzerland
United States
India
Lebanon
Italy
Singapore
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title:
A Phase 3, Double blind, Randomized, Multicenter, Parallel Group, Placebo controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects from 5 to < 18 Years of Age with Overactive Bladder

 Etude de phase 3, multicentrique, randomisée, en groupe parallèle, en double aveugle, contrôlée contre placebo visant à évaluer l’efficacité, la tolérance et la pharmacocinétique d’un traitement séquentiel par Mirabégron chez des enfants âgés de 5 à 18 ans présentant une vessie hyperactive

acronym:
Dolphin Study

 Etude Dolphin

lead_sponsor: Astellas Pharma Global Development Inc.


lead_sponsor: Kite, A Gilead Company

summary:
The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma.

After the end of KTE-C19-112 (ZUMA-12), participants who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.

ReferenceCitation: Neelapu SS, Dickinson M, Munoz J, Ulrickson ML, Thieblemont C, Oluwole OO, et al. 739 Primary Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) As First-Line Therapy in Patients with High-Risk Large B-Cell Lymphoma (LBCL) [Abstract]. 63rd American Society of Hematology (ASH) Annual Meeting and Exposition; 2021 11-14 December.

ReferenceCitation: Neelapu SS, Dickinson M, Ulrickson ML, Oluwole OO, Herrera AF, Thieblemont C, et al. 405 Interim Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) as First-Line Therapy in Patients (Pts) With High-Risk Large B-Cell Lymphoma (LBCL) [Abstract]. 62nd American Society of Hematology (ASH) Annual Meeting and Exposition Virtual; 2020 05-08 December.

ReferenceCitation: Neelapu SS, Chavez JC, Lin Y, Munoz J, Ujjani CS, Riedell P, et al. ZUMA-12: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel (Axi-Cel) as a First-Line Therapy in Patients (Pts) with High-Risk Large B-Cell Lymphoma (LBCL) [Abstract]. J Clin Oncol 2019;37 (15).

ReferenceCitation: Neelapu SS, Dickinson M, Munoz J, Ulrickson ML, Thieblemont C, Oluwole OO, Herrera AF, Ujjani CS, Lin Y, Riedell PA, Kekre N, de Vos S, Lui C, Milletti F, Dong J, Xu H, Chavez JC. Axicabtagene ciloleucel as first-line therapy in high-risk large B-cell lymphoma: the phase 2 ZUMA-12 trial. Nat Med. 2022 Apr;28(4):735-742. doi: 10.1038/s41591-022-01731-4. Epub 2022 Mar 21.

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: The University of Texas MD Anderson Cancer Center

title: A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12)

location_country:
United States
Australia
France


title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia

lead_sponsor: Cyclacel Limited


title: A Phase II multi-center, open label, randomized study to assess safety and efficacy of two different schedules of oral LDE225 in adult patients with relapsed/refractory or untreated elderly patients with acute leukemia

lead_sponsor: Novartis Pharma Services AG


title: A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi- Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)

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


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER)

acronym: TRA•CER

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


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With a History of Atherosclerotic Disease: Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2°P - TIMI 50)

acronym: TRA 2°P - TIMI 50

lead_sponsor: Schering-Plough Research Institute


acronym: INFORMS

summary: The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population

ReferenceCitation: Leppert D, Kropshofer H, Haring DA, Dahlke F, Patil A, Meinert R, Tomic D, Kappos L, Kuhle J. Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials. Neurology. 2022 May 24;98(21):e2120-e2131. doi: 10.1212/WNL.0000000000200258. Epub 2022 Apr 4.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

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license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2022 Mar;269(3):1663-1669. doi: 10.1007/s00415-021-10750-z. Epub 2021 Aug 15.

publisher_dissemination: Springer-Nature

ReferenceCitation: Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.

ReferenceCitation: Miller DH, Lublin FD, Sormani MP, Kappos L, Yaldizli O, Freedman MS, Cree BAC, Weiner HL, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, MacManus DG, Yousry TA, Gandini Wheeler-Kingshott CAM, Li B, Putzki N, Merschhemke M, Haring DA, Wolinsky JS. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study. Ann Clin Transl Neurol. 2018 Jan 30;5(3):346-356. doi: 10.1002/acn3.534. eCollection 2018 Mar.

oa_colors: green gold

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evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via OAI-PMH doi match)

repository_institution: PubMed Central - Europe PMC

license: cc-by

license_normalized: cc-by

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: California Digital Library - eScholarship

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: gold

publisher_dissemination: Wiley

ReferenceCitation: Lublin F, Miller DH, Freedman MS, Cree BAC, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, Merschhemke M, Li B, Putzki N, Liu FC, Haring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Mar 12;387(10023):1075-1084. doi: 10.1016/S0140-6736(15)01314-8. Epub 2016 Jan 28. Erratum In: Lancet. 2017 Jan 21;389(10066):254.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

version: submittedVersion

repositories:
UCL Discovery
univOAK

repositories_concat: UCL Discovery;univOAK

ReferenceCitation: Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. doi: 10.1002/ana.21880. No abstract available.

title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis

location_country:
Finland
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Turkey
Czechia
Canada
France


lead_sponsor: Loxo Oncology, Inc.

summary: This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 (pirtobrutinib) in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

ReferenceCitation: Cohen JB, Shah NN, Alencar AJ, Gerson JN, Patel MR, Fakhri B, Jurczak W, Tan XN, Lewis KL, Fenske T, Coombs CC, Flinn IW, Lewis DJ, Gouill SL, Palomba ML, Woyach JA, Pagel JM, Lamanna N, Barve MA, Ghia P, Eyre TA, Zinzani PL, Ujjani CS, Koh Y, Izutsu K, Lech-Maranda E, Tam CS, Sundaram S, Yin M, Nair B, Tsai DE, Balbas M, Mato AR, Cheah CY, Wang ML. MCL-133 Pirtobrutinib, a Highly Selective, Non-Covalent (Reversible) BTK Inhibitor in Previously Treated Mantle Cell Lymphoma: Updated Results From the Phase 1/2 BRUIN Study. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S394-S395. doi: 10.1016/S2152-2650(22)01569-5.

ReferenceCitation: Aslan B, Kismali G, Iles LR, Manyam GC, Ayres ML, Chen LS, Gagea M, Bertilaccio MTS, Wierda WG, Gandhi V. Pirtobrutinib inhibits wild-type and mutant Bruton's tyrosine kinase-mediated signaling in chronic lymphocytic leukemia. Blood Cancer J. 2022 May 20;12(5):80. doi: 10.1038/s41408-022-00675-9.

ReferenceCitation: Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.

ReferenceCitation: Mato AR, Shah NN, Jurczak W, Cheah CY, Pagel JM, Woyach JA, Fakhri B, Eyre TA, Lamanna N, Patel MR, Alencar A, Lech-Maranda E, Wierda WG, Coombs CC, Gerson JN, Ghia P, Le Gouill S, Lewis DJ, Sundaram S, Cohen JB, Flinn IW, Tam CS, Barve MA, Kuss B, Taylor J, Abdel-Wahab O, Schuster SJ, Palomba ML, Lewis KL, Roeker LE, Davids MS, Tan XN, Fenske TS, Wallin J, Tsai DE, Ku NC, Zhu E, Chen J, Yin M, Nair B, Ebata K, Marella N, Brown JR, Wang M. Pirtobrutinib in relapsed or refractory B-cell malignancies (BRUIN): a phase 1/2 study. Lancet. 2021 Mar 6;397(10277):892-901. doi: 10.1016/S0140-6736(21)00224-5.

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: University of California San Francisco, Medical Center at Paranassus

location_facility: University of North Carolina at Chapel Hill

location_facility: Tokai University Hospital- Isehara Campus

title: A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

location_country:
Italy
Poland
United Kingdom
Australia
Japan
Sweden
Switzerland
United States
Korea, Republic of
France


lead_sponsor: Idorsia Pharmaceuticals Ltd.

summary: A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease

ReferenceCitation: Wanner C, Kimonis V, Politei J, Warnock DG, Uceyler N, Frey A, Cornelisse P, Hughes D. Understanding and modifying Fabry disease: Rationale and design of a pivotal Phase 3 study and results from a patient-reported outcome validation study. Mol Genet Metab Rep. 2022 Mar 26;31:100862. doi: 10.1016/j.ymgmr.2022.100862. eCollection 2022 Jun.

repositories_concat: PubMed Central;escholarship.org

repositories_institution: California Digital Library - eScholarship

location_facility: Medizinische Klinik und Poliklinik I der Universität - Schwerpunkt Nephrologie

location_facility: Cardinal Wyszynski Institute of Cardiology

location_facility: University of Florida College of Medicine - Division of Nephrology, Hypertension & Renal Transplantation

location_facility: Hospital Universitario Ramon y Cajal. Servicio de Medicina Interna

location_facility: Allgemeines Krankenhaus der Stadt Wien - Universitätsklinik für Innere Medizin III - Klinische Abteilung für Nephrologie und Dialyse

location_facility: Hospital Universitari de Bellvitge; Hospitalet de Llobregat

location_facility: Vancouver Hospital & Health Sciences - Vancouver General Hospital

location_facility: University of Iowa Stead Family Children's Hospital - Division of Medical Genetics

location_facility: Royal Perth Hospital Unit - The University of Western Australia

location_facility: Lysosomal and Rare Disorders Research and Treatment Center

location_facility: University of Alabama at Birmingham - Nephrology Research Clinic

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: The Royal Free Hospital, Department of Haematology Royal Free London NHS Foundation Trust

location_facility: Charité-Virchow Klinikum - Nephrologie und Internistische Intensivmedizin

location_facility: Department of Pediatric Nutrition and Metabolic Diseases The Children's Memorial Health Institute

location_facility: Haukeland University Hospital Helse Bergen HF

location_facility: Royal Melbourne Hospital, Department of Respiratory Medicine

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Research Center, Hôpital Du Sacré-Coeur de Montréal

title: A Multi-center, Open-label, Uncontrolled, Single-arm, Extension Study to Determine the Long-term Safety and Tolerability of Oral Lucerastat in Adult Subjects With Fabry Disease

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


acronym: POSEIDON

lead_sponsor: Aimmune Therapeutics, Inc.

summary: The purpose of this study is to determine the efficacy and safety of AR101 in peanut-allergic children aged 1 to < 4 years.

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: University Hospital Southampton Foundation NHS Trust Southampton General Hospital

location_facility: Allergy & Asthma Medical Group and Research Center

location_facility: UNC-CH School of Medicine, Pediatric Allergy, Immunology & Rheumatology, Food Allergy

location_facility: Sean N. Parker Center for Allergy & Asthma Reseach, LPCH at El Camino Hospital

location_facility: Royal Manchester Children's Hospital Central Manchester University Hospitals

location_facility: Children's Center for Advanced Pediatrics Clinical Research Lab

location_facility: Guy's and St. Thomas' NHS Foundation Trust, Snowy Owl, First Floor, Evelina Children's Hospital

location_facility: University of Michigan Division of Allergy and Clinical Immunology

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

location_country:
United States
United Kingdom
Germany
France


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

acronym: ACCURACY

summary: This is a Phase 2, non comparative, open label, multicenter study of AL101 in patients with recurrent or metastatic ACC who harbor NOTCH 1,2,3,4 activating mutations.

lead_sponsor: Ayala Pharmaceuticals, Inc,

location_country:
France
United Kingdom
Netherlands
United States
Canada
Israel

location_facility: University of Maryland School of Medicine

location_facility: Hamilton Health Sciences Juravinski Cancer Centre

location_facility: H. Lee Moffitt Cancer Center & Research Institute


title: Embotrap eXtraction & Clot EvaLuation & Lesion Evaluation for NeuroThrombectomy

acronym: EXCELLENT

summary: A post-market registry evaluating the EmboTrap® Revascularization Device and CERENOVUS Large Bore Catheter/ EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

ReferenceCitation: Siddiqui AH, Waqas M, Brinjikji W, De Meyer SF, Doyle K, Fiehler J, Hacke W, Hanel RA, Jovin TG, Liebeskind DS, Yoo AJ, Zaidat OO, Andersson T, Nogueira RG. Embotrap Extraction & Clot Evaluation & Lesion Evaluation for NeuroThrombectomy (EXCELLENT) Registry design and methods. J Neurointerv Surg. 2022 Aug;14(8):783-787. doi: 10.1136/neurintsurg-2021-017671. Epub 2021 Oct 13.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: acceptedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

lead_sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

location_country:
Germany
France
United Kingdom
Switzerland
Belgium
United States
Israel

location_facility: Barrow Neurological Institute at St. Joseph's Hospital

location_facility: Emory School of Medicine at Grady Memorial Hospital

location_facility: Vascular Neurology of Southern California: Dr. M. Asif Taqi

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: University of Miami- Jackson Memorial Hospital


summary: Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep

location_facility: Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck

location_facility: Queensway Sleep Lab Sleep Clinic (MedSleep)

location_facility: Sleep Disorders Centers of the Mid-Atlantic

location_facility: Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald

location_facility: Jacksonville Center for Clinical Research

location_facility: Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg

location_facility: Sleep Disorders Center of the Mid-Atlantic

location_facility: Clinical Trial Center North GmbH & Co. KG

location_facility: Clinical Research Group of St. Petersburgh

location_facility: Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset

location_facility: Fleming Island Center for Clinical Research

location_facility: Artemis Institute For Clinical Research - Riverside

location_facility: Acibadem City Clinic Tokuda Hospital EAD

location_facility: Hospital UZ Leuven_ Pneumology Department

location_facility: ZMS Zentrum für medizinische Studien GmbH

location_facility: Hospital MAZ - Neurophisiology and Sleep Department

location_facility: SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály

location_facility: Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit

location_facility: Oregon Center for Clinical Investigations,Inc

location_facility: Klinik imd Poliklinik fur Neurochirurgie

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin

location_facility: 4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu

location_facility: Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University

location_facility: St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin

location_facility: 2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu

location_facility: EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej

location_facility: Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar

location_facility: Pulmonary Associates of the Southeast/WCR

location_facility: Universitetssjukhuset Örebro Neurokliniken, Sömnenheten

location_facility: St. Francis Sleep Allergy and Lung Institute

location_facility: Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy

location_facility: Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño

location_facility: Centro Médico Teknon - Medicina del Sueño

location_facility: Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)

location_facility: CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)

title: Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Three Doses, 40-week Extension to Studies ID-078A301 and ID-078A302 to Assess the Long Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

location_country:
Finland
Germany
Poland
Hungary
Denmark
Sweden
Switzerland
Belgium
United States
Korea, Republic of
Spain
Bulgaria
Canada
France


lead_sponsor: Zambon SpA

summary: The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in single lung transplant recipients.

location_facility: Wythenshawe Hospital - Cardiothoracic Transplant Unit

location_facility: Indiana University Health Methodist Hospital

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: University Hospital of South Manchester NHS Foundation Trust

location_facility: University of Kentucky Albert B. Chandler Hospital

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hannover Medical School - MHH Klinik für Pneumologie

location_facility: University of Texas Southwestern Medical Center

title: A Phase III Clinical Trial to Demonstrate Efficacy / Safety of Liposomal Cyclosporine A + Standard of Care (SoC) vs SoC Alone in Treating Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans in Patients Post Single Lung Transplant

location_country:
Germany
France
United Kingdom
Belgium
United States
Spain
Israel


summary: This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 or CFZ533 in patients with SLE to enable further development of these compounds as treatment in this disease population

title: A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)

location_country:
Germany
Poland
Hungary
Argentina
Israel
Australia
Japan
Korea, Republic of
China
Spain
Thailand
Taiwan
Czechia
Russian Federation
France


title: An International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients with Multiple Myeloma

lead_sponsor: Merck & Co., Inc


title: A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users

lead_sponsor: Integrated Therapeutics Group Inc


title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes  (39039039ACS2001)
 The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower cardiovascular events in addition to Aspirin with or without thienopyridine therapy in Subjects with Acute Coronary Syndrome)

acronym: The ATLAS ACS TIMI 46 Trial

lead_sponsor: Bayer HealthCare AG


title: A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

lead_sponsor: Abbott GmbH & Co. KG


title: Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study

summary: This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.

status: Unknown status

lead_sponsor: Mardil Medical

location_country: Germany Poland Hungary Netherlands Panama Canada France

location_facility: Libin Cardiovascular Institute, University of Calgary

location_facility: London Health Sciences Centre, University Hospital

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Québec (IUCPQ)

location_facility: University of British Columbia, St. Paul's Hospital

location_facility: Semmelweis University Heart and Vascular Center

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawia


title: Mucopolysaccharidosis VII Disease Monitoring Program (MPS VII DMP)

summary: The objectives of this study are to characterize MPS VII disease presentation and progression and assess long-term effectiveness and safety, including hypersensitivity reactions and immunogenicity of vestronidase alfa.

lead_sponsor: Ultragenyx Pharmaceutical Inc

location_country:
Germany
Portugal
Argentina
Brazil
Netherlands
United States
Spain
Turkey
France

location_facility: Erasmus University Medical Center Rotterdam

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Hospital Universitario Virgen del Rocío Pabellón Infantil

location_facility: Laboratorio de Neuroquimica Dr. N.A. Chamoles S.R.L.

location_facility: New York University Langone Medical Center

location_facility: Centre Hospitalier Universitaire La Timone


title: A 12-week treatment, multi-center, randomized, parallel group, blinded, double dummy study to compare the efficacy and safety of Indacaterol (150 μg o.d.) delivered via a SDDPI with Tiotropium (18 μg o.d.) delivered via a HandiHaler®, in patients with moderate-to-severe COPD.


title:
A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of
 Repeated Administration of Adalimumab in Subjects with Crohn's Disease

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title: Open-label, Single-Arm, Phase 2 Study of Oral HDAC-inhibitor Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma (FORERUNNER)

acronym: FORERUNNER

summary: This study in patients with relapsed/refractory follicular lymphoma who have undergone at least 3 lines of therapy. Patients will receive abexinostat 80 mg (4 × 20 mg tablets) twice a day (BID) in a "one week on, one week off" schedule.

lead_sponsor: Xynomic Pharmaceuticals, Inc.

location_country:
United States
Spain
France

location_facility: Central Texas Veterans Health Care System - NAVREF

location_facility: Bone Marrow Transplant Hematology Oncology Associates

location_facility: Norton Cancer Institute - St. Matthews Campus

location_facility: Advocate Medical Group - Park Ridge, Luther Lane - Oncology


title: International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group

summary: The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.

lead_sponsor: Charite University, Berlin, Germany

collaborators: Australian & New Zealand Children's Haematology/Oncology Group

collaborators: St. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria)

collaborators: European Organisation for Research and Treatment of Cancer - EORTC

collaborators: University Hospital Motol (Co-Sponsor Czech Republic)

collaborators: Copenhagen University Hospital, Rigshospitalet (co-sponsor, Denmark)

collaborators: Turku University Central Hospital (co-sponsor, Finland)

collaborators: Centre Hospitalier Universitaire de Nice

collaborators: Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)

collaborators: Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)

collaborators: Ospedale Pediatrico Bambino (co-sponsor, Italy)

collaborators: Prinses Máxima Centrum (Co-Sponsor Netherlands)

collaborators: Oslo University Hospital (co-sponsor, Norway)

collaborators: Medical University of Wroclaw (Co-Sponsor Poland)

collaborators: Instituto Português de Oncologia de Lisboa (co-sponsor, Portugal)

collaborators: Karolinska University Hospital Stockholm (co-sponsor, Sweden)

collaborators: Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)

collaborators: Central Manchester University Hospitals NHS Foundation Trust (co-sponsor, UK)

location_country:
Finland
Italy
Poland
Portugal
Israel
Norway
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
United Kingdom
Czechia
France

location_facility: Australian & New Zealand Childhood Hematology & Oncology Group

location_facility: Hòpital Universitaire des Enfants Reine Fabiola

location_facility: Dpt. SCT and Hematology/Oncology University Wroclaw

location_facility: Copenhagen University Hospital (Rigshospitalet)


title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

summary:
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.

primary_purpose: Other

lead_sponsor: Medtronic Vascular

location_country:
United States
Slovakia
Belgium
France

location_facility: New York-Presbyterian Hospital/ Columbia University Medical Center

location_facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s


title: A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response

summary: To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib versus asciminib 80mg in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Australia
Japan
Chile
Czechia
Canada
France
Portugal
Hong Kong
Denmark
United States
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: SUNY Stony Brook Medical Oncology Hematology/Oncology

location_facility: Sidney Kimmel Comprehensive Cancer Center


title: An Open Label Extension Study of Voxelotor (GBT440) Administered Orally to Participants With Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials

summary: Open Label Extension Study of Voxelotor Clinical Trial Participants with Sickle Cell Disease Who Participated in Voxelotor Clinical Trials

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Italy
United Kingdom
Netherlands
Lebanon
United States
Kenya
Turkey
Oman
Canada
Egypt
France

location_facility: Investigational Drug Service, Duke University Hospital

location_facility: Montefiore - Einstein Center for Cancer Care

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Alexandria Clinical Research Center, Faculty of Medicine, Alexandria University

location_facility: Johns Hopkins University/Sickle Cell Infusion Center

location_facility: KEMRI/CRDR - Kenya Medical Research Insititute - Center for respiratory Disease Research

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Methodist Comprehensive Sickle Cell Clinic

location_facility: Clinical Research Services Unit- Virginia Commonwealth University

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: Hôpital Européen Georges Pompidou - Medecine Interne

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: Abu El Rich Hospital,Cairo University Hospital

location_facility: Mersin Universitesi Tip Fakultesi Saglik Arastirma ve Uygulama Hastanesi

location_facility: Centres for Disease Control and Prevention

location_facility: Our Lady of the Lake Physician Group-Medical Oncology

location_facility: Texas Children's Hospital - Investigational Pharmacy

location_facility: Children's Healthcare of Atlanta at Hughes Spalding

location_facility: Clinical and Translational Research Center (CTRC)

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: University of Illinois Hospital and Health Science System

location_facility: Jackson Memorial Hospital (Investigational Drug Services)

location_facility: Medical University of South Carolina: Investigational Drug Services Pharmacy

location_facility: Brigham and Women's Hospital Research Pharmacy

location_facility: Children's Healthcare of Atlanta - Scottish Rite

location_facility: The Egyptian Thalassemia Association ( E.T.A)

location_facility: Homerton University Hospital NHS Foundation Trust

location_facility: University of Miami Hospital & Clinics/SCCC, Research Pharmacy (Investigational Drug Services)

location_facility: Toronto General Hospital-University Health Network

location_facility: Medical University of South Carolina - Comprehensive Sickle Cell Clinic

location_facility: Guys and STt Thomas NHS Foundation Trust

location_facility: University of Illinois at Chicago Clinical Research Center


acronym: Marigold

lead_sponsor: Marinus Pharmaceuticals

summary: A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.

ReferenceCitation: Knight EMP, Amin S, Bahi-Buisson N, Benke TA, Cross JH, Demarest ST, Olson HE, Specchio N, Fleming TR, Aimetti AA, Gasior M, Devinsky O; Marigold Trial Group. Safety and efficacy of ganaxolone in patients with CDKL5 deficiency disorder: results from the double-blind phase of a randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2022 May;21(5):417-427. doi: 10.1016/S1474-4422(22)00077-1. Erratum In: Lancet Neurol. 2022 Jul;21(7):e7.

repositories_concat: UCL Discovery

location_facility:
Marinus Research Facility
Marinus Research Site

title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed by Long-term Open-label Treatment

location_country:
France
Italy
Poland
United Kingdom
Australia
United States
Russian Federation
Israel


title: A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and Irinotecan for Patients with Metastatic Colorectal Cancer

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 versus Placebo in Subjects with Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

lead_sponsor: Exelixis, Inc.


acronym: Alliance

lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in HIV and hepatitis B virus (HBV) treatment naive, HIV-1 and HBV co-infected adults.

ReferenceCitation: Avihingsanon, A. 2022. Week 48 results of a Phase 3 randomized controlled trial of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs dolutegravir + emtricitabine/tenofovir Disoproxil Fumarate (DTG+F/TDF) as initial treatment in HIV/HBV-coinfected adults (ALLIANCE). AIDS, 29 July 29-2 August 2022, Montréal, Québec, Canada.

ReferenceCitation: Avihingsanon A, Lu H, Leong CL, Hung CC, Koenig E, Kiertiburanakul S, Lee MP, Supparatpinyo K, Zhang F, Rahman S, D'Antoni ML, Wang H, Hindman JT, Martin H, Baeten JM, Li T; ALLIANCE Study Team. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 and hepatitis B coinfection (ALLIANCE): a double-blind, multicentre, randomised controlled, phase 3 non-inferiority trial. Lancet HIV. 2023 Oct;10(10):e640-e652. doi: 10.1016/S2352-3018(23)00151-0. Epub 2023 Jul 23.

location_facility: Taipei City Hospital Linsen, Chinese Medicine and Kunming Branch

location_facility: Bamrasnaradura Infectious Diseases Institute

location_facility: AHEPA University Hospital of Thessaloniki

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Faculty of Medicine, Chiang Mai University

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Thai Red Cross AIDS Research Centre (HIV-NAT)

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Beijing YouAn Hospital, Capital Medical University

location_facility: Beijing Ditan Hospital Capital Medical University

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: CHUVI - Hospital Universitario Alvaro Cunqueiro

location_facility: Instituto Dominicano de Estudios Virologicos (IDEV)

location_facility: Hospital General Universitario Santa Lucia

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

location_facility: Ministry of Health and Welfare Taoyuan General Hospital

location_facility: 1st Affiliated Hospital of Zhejiang University

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)

location_facility: Hospital General Universitario de Valencia

location_facility: Korgialenio-Benakio Greek Red Cross General Hospital

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

location_country:
Hong Kong
Japan
United States
China
Korea, Republic of
Spain
Greece
Malaysia
Thailand
Taiwan
Turkey
Dominican Republic
Puerto Rico
France


title: A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome

lead_sponsor: Eisai Limited