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

acronym: AHFIRM

summary: This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).

lead_sponsor: Durect

collaborators: CTI Clinical Trial and Consulting Services

location_country:
United Kingdom
Australia
Austria
Belgium
United States
France

location_facility: University Hospitals Plymouth NHS Trust - Derriford Hospital

location_facility: Centre Hospitalier Régional Universitaire (CHRU) Besançon - Hôpital Jean Minjoz

location_facility: Landeskrankenhaus (LKH) - Universitätsklinikum Graz

location_facility: Northwell Health - North Shore University Hospital

location_facility: Saint Luke's Health System - Saint Luke's Hospital of Kansas City

location_facility: Virginia Commonwealth University Medical Center

location_facility: University of California Davis (UC Davis) Medical Center

location_facility: Keck Hospital of University of Southern California (USC)

location_facility: University of Virginia (UVA) Health - University Hospital

location_facility: New York-Presbyterian - Weill Cornell Medical Center

location_facility: MedStar Health - MedStar Georgetown University Hospital

location_facility: Utah Health - The University of Utah Hospital

location_facility: Harborview Medical Center - University of Washington

location_facility: Centre Hospitalier Universitaire (CHU) de Lille - Hôpital Jeanne de Flandre

location_facility: University of Alabama at Birmingham (UAB) Hospital

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: University of California San Francisco (UCSF) Medical Center

location_facility: University of Nebraska Medical Center (UNMC)

location_facility: Hospices Civils de Lyon - Hôpital de la Croix-Rousse

location_facility: Washington University School of Medicine

location_facility: Université libre de Bruxelles (ULB) - Hôpital Erasme

location_facility: Imperial College Healthcare NHS Trust - St. Mary's Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Baylor College of Medicine Medical Center

location_facility: Medical University of South Carolina (MUSC) Health - University Medical Center

location_facility: University of Texas Southwestern (Clements University Hospital)

location_facility: Royal Free London NHS Foundation Trust Hospital

location_facility: University of Texas Southwestern Medical Center


title: ConTTRibute: A Global Observational Multicenter Long-Term Study of Patients With Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis)

acronym: ConTTRibute

summary:
The purpose of this study is to:

Describe epidemiological and clinical characteristics, natural history and real-world clinical management of ATTR amyloidosis patients
Characterize the safety and effectiveness of patisiran as part of routine clinical practice in the real-world clinical setting
Describe disease emergence/progression in pre-symptomatic carriers of a known disease-causing transthyretin (TTR) mutation

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Italy
Portugal
Israel
Denmark
Brazil
Netherlands
United States
Spain
Taiwan
France

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Drug

lead_sponsor: Hoffmann-La Roche

summary: This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Saratov State Medical University of RosZdrav; Neurology

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Austin Hospital; Department of Neurology

location_facility: N.P. Bechtereva Institute of the Human Brain

location_facility: 5th Cherkasy City Center of Primary Health Care

location_facility: Federal center of brain research and neurotechnologies

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: Zaporizhia City Multispecialty Clinical Hospital #9

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: SI USSRI of Medical and Social Problems of Disabilities of MOHU

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage

location_facility: Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia

location_facility: Universitätsklinikum Schleswig-Holstein; Klinik für Neurologie

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: KSMU Interregional Clinical Diagnostic Centre

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: National Center of Social Significant Disease

location_facility: Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie

location_facility: Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: The NeuroMedical Clinic of Central Louisiana

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: Centro de Especialidades Neurológicas y Rehabilitación - CENyR

location_facility: Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia

location_facility: Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?; Neurology Department

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Medical Center of Private Execution First Private Clinic

location_facility: Hôpital Charles Nicolle; Service de Neurologie

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Hospital Alvaro Cunqueiro; Servicio de Neurologia

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: Somogy Vármegyei Kaposi Mór Oktató Kórház

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Neurology Associates, PA; Research Department

location_facility: Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: Oklahoma Medical Research Foundation; MS Center of Excellence

location_facility: SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii

status: Active, not recruiting

title: A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis

primary_purpose: Treatment

type: EudraCT Number

source: euctr

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

design_allocation: Randomized

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Ukraine
Belgium
Peru
Italy
United Kingdom
Spain
Greece
Russian Federation

study_type: Interventional

ipd_sharing: Yes


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)

summary: The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Germany
Italy
Poland
Hungary
Israel
Australia
United States
Spain
Czechia
Ukraine
Bulgaria
Canada
Serbia
France

location_facility:
Valencia
Lviv
Chocen
Ocala, Florida
Berlin
North Dartmouth, Massachusetts
Brandenburg,
Petah Tiqva
Krakow
Houston, Texas
Tampa, Florida
Haag in Oberbayern
Cassino
Erina, New South Wales
Zaporizhzhya
Warsaw,
Port Orange, Florida
Toledo, Ohio
Creteil,
Barcelona
Kiev
Stadtroda
Siemianowice Slaskie
Adventura, Florida
Las Vegas, Nevada
Bydgoszcz
Englewood, Colorado
Milano
Bad Homburg
Los Angeles, California
Haifa
Sofia
Rome
Ancona
Woolloongabba, Queensland
Gera
Columbus, Ohio
Cleveland, Ohio
Kraków
Shoham
Kansas
Cincinnati, Ohio
Bochum
Ottawa, Ontario
Torino
Padova
Prague,
Klinikum rechts der Isar der TU München
Muenchen
Muenster
Richmond, Virginia
Chicago, Illinois
Parkville, Victoria
Asheville, North Carolina
Nantes CEDEX 1
Rozzano Milano
Farmington Hills, Michigan
Hallandale Beach, Florida
Boston, Massachusettes
Lublin
Terrassa
Houston,Texas
Rychnov nad Kněžnou
Prague
Frenso, California
Boca Raton, Florida
Lubbock, Texas
Katowice
Little Rock, Arkansas
Elche
Memphis, Tennessee
Zaporiizhzhya
Virginia Beach, Virginia
Cypress, Texas
Maitland, Florida
Fountain Valley, California
Scarborough, Maine
Port Charlotte, Florida
Belgrade
Augusta, Georgia
Kragujevac
Nîmes cedex
Winter Park, Florida
Pasadena, California
Coral Springs, Florida
Ashkelon
Round Rock, Texas
Vinnitsa
Kirkland, Washington
Kogarah, New South Wales
Budapest
Georgetown, Texas
Pisa
Toulouse Cedex
Madrid
Tel Aviv
Pleven


acronym: TWINSS Extn

lead_sponsor: Novartis Pharmaceuticals

summary: This study will evaluate the safety and tolerability of iscalimab at two dose levels in patients with Sjögren's Syndrome, who participated in the TWINSS core study, CCFZ533B2201(NCT03905525). Additionally, this Extension study will further explore the pharmacokinetics (PK) and efficacy of iscalimab at two dose level.

title: A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's Syndrome

enrollment_type: Actual

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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

design_allocation: Non-Randomized

location_country:
Germany
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Colombia
Portugal
Hungary
United States
Romania
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Greece
Russian Federation
Israel


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)

summary:
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.

Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.

collaborators:
Adagene Inc
Tempest Therapeutics

sponsor_collaborators:
Hoffmann-La Roche
Adagene Inc
Tempest Therapeutics

location_country:
France
New Zealand
United States
China
Korea, Republic of
Taiwan
Israel

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Rabin Medical Center-Beilinson Campus; Davidof Institute

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: The University of Texas Southwestern Medical Center at Dallas

location_facility: University of California San Francisco Cancer Center; Pharmacy


type: Registry Identifier

title: Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)

summary:
Primary Objective:

Safety run-in part: to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population
Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): to assess the antitumor activity of several dose levels (DLs; if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population

Secondary Objectives:

To assess the safety and tolerability of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy with pemetrexed in the NSQ NSCLC population
To assess the antitumor activity of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
To assess the durability of the response to treatment with several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population
To assess the pharmacokinetics (PK) of tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin, each when given in combination as a doublet (tusamitamab ravtansine + pembrolizumab) or a triplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy) or a quadruplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed)
To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum based chemotherapy with or without pemetrexed

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:
Hungary
Argentina
Israel
Brazil
United States
Spain
Chile
Czechia
France

location_facility: Centro de Investigacion y Desarrollo Oncologico (CIDO) Hochstetter 599 of. 602-603-1001, Temuco_Investigational Site Number :1520005

location_facility: CHRU BREST 5 Avenue Foch_Investigational Site Number :2500003

location_facility: Centre François Magendie Hôpital du Haut Lévèque Av.de Magellan_Investigational Site Number :2500001

location_facility: Veszprém Megyei Tüdőgyógyintézet 049/2 Hrsz_Investigational Site Number :3480004

location_facility: Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760004

location_facility: Pôle régional de Cancérologie 2 rue de la Milèterie BP 577_Investigational Site Number :2500004

location_facility: Nemocnice AGEL Ostrava - Vitkovice Plicní oddělení Zalužanského 2214/35_Site Number :2030002

location_facility: Renovatio Clinical_Investigational Site Number :8400004

location_facility: ONCOCENTRO APYS Av. La Marina 1702, 2do piso, Viña del Mar_Investigational Site Number :1520003

location_facility: ICEGCLINIC Avenida Serafín Zamora 190 Torre B, piso 4. La Florida_Investigational Site Number :1520006

location_facility: cCare/California Cancer Associates Site Number : 8400005

location_facility: KU Medical Center_Investigational Site Number :8400002

location_facility: Orlandi Oncologia General Salvo 159, Providencia_Investigational Site Number :1520002

location_facility: Országos Onkológiai Intézet Ráth György u. 7_Investigational Site Number :3480002

location_facility: Virginia Cancer Specialists_Investigational Site Number :8400001

location_facility: Fakultní nemocnice Olomouc Onkologická klinika I.P. Pavlova 6_Site Number :2030001

location_facility: Institut Sainte-Catherine 250 Chemin de Baigne-Pieds_Investigational Site Number :2500005


title: A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

summary: The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. It will also conduct a clinical PK evaluation of SC1 and SC2 blinatumomab formulations.

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:
Germany
Italy
Australia
Japan
Netherlands
Austria
United States
Spain
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

location_facility: Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


lead_sponsor: Takeda

summary:
This study is about an anticancer drug called ponatinib which is a tyrosine kinase inhibitor given with chemotherapy to children, teenagers, and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia who have relapsed or are resistant to other treatment.

The main aims of this study are to confirm the highest dose of ponatinib tablets and minitablet capsules that can be given to participants with acceptable side effects, and to evaluate if participant's leukemia achieves remission.

Participants will take ponatinib tablets with chemotherapy. For participants who cannot swallow tablets or who are receiving less than a 10 mg dose, a capsule with small ponatinib minitablets inside will be provided. Participants will take ponatinib for 10 weeks in combination with chemotherapy (reinduction and consolidation blocks) and will be followed up for at least 3 years.

location_facility: West China Second University Hospital, Sichuan Univesity

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Ospedale Infantile Regina Margherita - INCIPIT - PIN

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP

location_facility: Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Princess Maxima Center for Pediatric Oncology - PIN

location_facility: Graacc Grupo de Apoio Ao Adolescente E A Crianca Com Cancer

location_facility: Childrens Medical Center Research Institute at UT Southwestern

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Royal Hospital for Children (Glasgow) - PPDS - PIN

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Royal Children's Hospital Melbourne - PIN

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

location_facility: Children's Hospital of Soochow University

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Hospital Infantil Universitario Nino Jesus - PIN

location_facility: Cincinnati Children's Hospital Medical Center - PIN

location_facility: Fndazione MBBM (MONZA E BRIANZA PER IL BAMBINO E LA SUA MAMMA) - c/o Centro Maria Letizia Verga

location_facility: The Second Hospital of Anhui Medical University

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Severance Hospital Yonsei University Health System

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

location_facility: Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca

title: A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation

type: Other Identifier

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Italy
Poland
Portugal
United Kingdom
Argentina
Australia
Brazil
Netherlands
Mexico
United States
China
Korea, Republic of
Spain
Czechia
France


lead_sponsor: Merck Sharp & Dohme LLC

summary: The main purpose of this study is to evaluate the antitumor activity and safety of Lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration. Participants will be enrolled into initial tumor-specific cohorts which will be expanded based on observed response.

ReferenceType: derived

ReferenceCitation: Gaspar N, Campbell-Hewson Q, Gallego Melcon S, Locatelli F, Venkatramani R, Hecker-Nolting S, Gambart M, Bautista F, Thebaud E, Aerts I, Morland B, Rossig C, Canete Nieto A, Longhi A, Lervat C, Entz-Werle N, Strauss SJ, Marec-Berard P, Okpara CE, He C, Dutta L, Casanova M. Phase I/II study of single-agent lenvatinib in children and adolescents with refractory or relapsed solid malignancies and young adults with osteosarcoma (ITCC-050)☆. ESMO Open. 2021 Oct;6(5):100250. doi: 10.1016/j.esmoop.2021.100250. Epub 2021 Sep 22.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

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

repository_normalized: univOAK

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
UCL Discovery
univOAK

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_facility: Monroe Carell Jr. Children's Hospital at Vanderbilt ( Site 0102)

location_facility: Seoul National University Hospital ( Site 0875)

location_facility: Children's Hospital of Colorado ( Site 0110)

location_facility: Institute for Oncology and Radiology of Serbia ( Site 0780)

location_facility: Fakultni nemocnice v Motole ( Site 0650)

location_facility: A.O.Universitaria Meyer-Oncology & Haematology Unit ( Site 0400)

location_facility: St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0554)

location_facility: Hospital Universitario Sant Joan de Deu ( Site 0476)

location_facility: Fakultni Nemocnice Brno Bohunice ( Site 0651)

location_facility: Univerzitetska decja klinika ( Site 0782)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 0603)

location_facility: Klinicki bolnicki centar Rijeka ( Site 0726)

location_facility: Royal Childrens Hospital Melbourne ( Site 0802)

location_facility: Klinika za djecje bolesti Zagreb ( Site 0725)

location_facility: Cancercare Rondebosch Oncology ( Site 0575)

location_facility: Skanes Universitetssjukhus Lund. ( Site 0525)

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0602)

location_facility: Ospedale Infantile Regina Margherita ( Site 0412)

location_facility: Hospital de Niños Ricardo Gutiérrez ( Site 0125)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 0678)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0553)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0677)

location_facility: Dmitry Rogachev National Research Center ( Site 0550)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0401)

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)

location_facility: Unidad Nacional de Oncologia Pediatrica ( Site 0176)

location_facility: Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)

location_facility: Starship Childrens Hospital ( Site 0826)

location_facility: Queensland Children s Hospital ( Site 0804)

location_facility: Hospital Universitario Austral ( Site 0126)

location_facility: Ege Universitesi Tip Fakultesi ( Site 0601)

location_facility: Mary Crowley Cancer Research Center ( Site 0107)

title: An Open-Label, Multicenter Phase 2 Basket Study to Evaluate the Antitumor Activity and Safety of Lenvatinib in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Malignancies

location_country:
New Zealand
Argentina
Australia
Turkey
Croatia
Czechia
Serbia
France
Hungary
United States
Belgium
Peru
Italy
Guatemala
Sweden
Korea, Republic of
Spain
South Africa
Russian Federation
Israel


title: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

acronym: ROSY-O

summary: The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

status: Enrolling by invitation

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Finland
Germany
Poland
Brazil
Turkey
Czechia
Canada
France
Slovenia
Portugal
Hungary
Denmark
United States
Belgium
China
Italy
United Kingdom
Sweden
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel

status_simplified: Unknown


title: The SQUID Trial for the Embolization of the Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma (STEM)

acronym: STEM

summary: STEM Study is a pivotal, international, multi-center, prospective, randomized (1:1) controlled trial designed to provide an assessment of the safety and effectiveness of Middle Meningeal Artery (MMA) embolization with SQUID for the management of Chronic Subdural Hematoma (cSDH)

lead_sponsor: Balt USA

location_country:
United States
Spain
Germany
France

location_facility: Penn State Health Hershey Medical Center

intervention_type: Device


title: A Phase 2/3, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and the Safety of ABX464 in Treating Inflammation and Preventing COVID-19 Associated Acute Respiratory Failure in Patients Aged ≥ 65 and Patients Aged ≥18 With at Least One Additional Risk Factor Who Are Infected With SARS-CoV-2.

acronym: Mir-Age

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

status: Terminated

study_completion_date_type: Actual

lead_sponsor: Abivax S.A.

location_country:
Germany
Italy
United Kingdom
Brazil
Mexico
Belgium
Spain
France

location_facility: Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - Instituto de Pesquisa Clínica Carlos Borborema

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Ospedale di Vittorio Veneto - Medecina generale

location_facility: Ospedale A. Manzonidi Lecco - ASST Lecco

location_facility: Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid

location_facility: Centro Oncológico de Roraima - CECOR - NAP

location_facility: Instituto Nacional de Infectologia Evandro Chagas - FIOCRUZ Rio de Janeiro

location_facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Infectious Diseases

location_facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Départemental de Vendée


acronym: MIT-E

lead_sponsor: PTC Therapeutics

summary: This is a parallel-arm, double-blind, placebo-controlled study with a screening phase that includes a 28-day run-in phase to establish baseline seizure frequency, followed by a 24-week, randomized, placebo-controlled phase. After completion of the randomized, placebo-controlled phase, participants may enter a 48-week, long-term, extension phase during which they will receive open-label treatment with vatiquinone.

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Centrum Wsparacia Pediatrycznych Badań Klinicznych

location_facility: Hospital Ruber Internacional, Neurology Department, Epilepsy Program

location_facility: A.P.H.P - Hôpital Necker-Enfants Malades - Service de Neurologie pédiatrique

location_facility: U.O.C. Malattie Muscolari e Neurodegenerative, Dipartimento di Scienze Neurologiche e Psichiatriche, Ospedale Pediatrico Bambino Gesù

location_facility: UOC Neuropsichiatria Infantile, Istituto Neurologico Carlo Besta-Fondazione IRCCS

location_facility: Alberta Children's Hospital, University of Calgary

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Children's National Medical Center - Department Of Neurology

location_facility: Pediatric Genetics Clinic (Main MGH Hospital)

location_facility: Karolinska University hospital, Astrid Lindgrens Children Hospital

location_facility: CHU de Strasbourg - Hôpital de Hautepierre - Service de Neuropédiatrie

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac - Département de neuropédiatrie

title: Efficacy and Safety Study of Vatiquinone for the Treatment of Mitochondrial Disease Subjects With Refractory Epilepsy

location_country:
Italy
Poland
United Kingdom
Japan
Sweden
United States
Spain
Canada
France

ipd_sharing: Undecided


title: A Phase Ib Trial to Evaluate the Efficacy and Safety of Bintrafusp Alfa Monotherapy in Metastatic or Locally Advanced/Unresectable Urothelial Cancer With Disease Progression or Recurrence Following Treatment With a Platinum Agent

summary: The purpose of this study is to evaluate bintrafusp alfa in participants with metastatic or locally advanced urothelial cancer. This trial provides the first evaluation of bintrafusp alfa in participants with urothelial cancer that has progressed following platinum therapy.

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

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Merck KGaA, Darmstadt, Germany

location_country:
United Kingdom
Netherlands
United States
Spain
Canada
France


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

summary: Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Albireo

location_country:
Germany
Poland
New Zealand
Australia
Turkey
Canada
France
Hungary
United States
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Israel

location_facility: ISMETT - Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

location_facility: University Children´s Hospital Tuebingen

location_facility: Birmingham Women´s and Children´s Hospital

location_facility: Hacettepe University Ihsan Dogramaci Childrens Hospital

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

location_facility: Guangzhou Women and Children's Medical Center

location_facility: Necker University Hospital - Enfants malades

location_facility: Schneider Children´s Medical Center of Israel

location_facility: Istanbul University, Istanbul Medical Faculty

location_facility: Children's Healthcare of Atlanta - Emory University School of Medicine

location_facility: UCSF Benioff Children's Hospital San Francisco

location_facility: University of Michigan Children's Hospital

location_facility: Seoul National University Children's Hospital

location_facility: Nemours/Alfred I. duPont Hospital for Children

location_facility: University Medical Center Hamburg-Eppendorf UKE

location_facility: NewYork-Presbyterian Morgan Stanley Children's Hospital

location_facility: Semmelweis Egyetem I.sz Gyermekgyógyászati Klinika


acronym: ADJUST

intervention_type: Biological

lead_sponsor: LEO Pharma

summary: This study investigates if an adjusted brodalumab dosage regimen will give improved efficacy in psoriasis in patients with a body weight of over 120 kg. The increased dosage regimen will be compared to the standard brodalumab treatment plus placebo.

title: Adjustable Brodalumab Dosage Regimen Compared With Standard Brodalumab Treatment for 52 Weeks in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Netherlands
Belgium
Spain
Greece
Czechia
France


title: A Phase 3, Multicenter, Open-Label, Single-Arm Study of Bentracimab (PB2452) in Ticagrelor-Treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure (REVERSE-IT Trial)

acronym: REVERSE-IT

summary:
This is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure.

At least 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. These populations will be enrolled based on separate inclusion criteria.

lead_sponsor: PhaseBio Pharmaceuticals Inc.

location_country:
Italy
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
China
Spain
Canada
France

location_facility: Centre intégré universitaire de santé et de services sociaux du Nord-de-l'lle-de-Montréal (CIUSSS NIM)/Hopital du Sacré-Coeur-de-Montréal

location_facility: Tianjin Medical University General Hospital

location_facility: Beijing Anzhen Hospital, Capital Medical University

location_facility: Klinische Abteilung für Innere Medizin 3 Universitätsklinikum St. Pölten

location_facility: University Hospital Leuven, Universitair Ziekenhuis Leuven Dienst Bloedings- en Vaatziekten

location_facility: Ziekenhuis Oost-Limburg Study Center Intensive Care

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Klinik Ottakring 3rd Med Dept, Cardiology and Intensive Care Medicine

location_facility: First Affiliated Hospital of Xi'an Jiaotong University

location_facility: University of Florida Health, Jacksonville

location_facility: Universitatsspital Basel Department of Cardiology

location_facility: Azienda Ospedaliero-Universitaria di Parma Cardiologia

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: AZ Sint-Jan Brugge-Oostende AV Poli Cardiologie

location_facility: Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval

location_facility: Ascension St. John Clinical Research Institute

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Algemeen Stedelijk Ziekenhuis (ASZ) Study Center Cardiology

location_facility: Skane University Hospital, Department of Cardiology

location_facility: Sheffield Teaching Hospitals, NHS Foundation Trust, Northern General Hospital

location_facility: East and North Hertfordshire, NHS Trust, Lister Cardiac Research Office, Cardiology Green Zone, Lister Hospital

location_facility: Duke Heart Center at Southeastern Health

location_facility: Hospital Universitario Vírgen de la Victoria

location_facility: University Hospital Antwerp Cardiology Department - Clinical Trials

location_facility: Assistance Publique-Hopitaux de Paris (AP-HP) Pitie-Salpetriere Hospital

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Hospital Universitario 12 de Octubre, Residencia general

location_facility: CHRU de Tours - Hopital Trousseau Service de Cardiologie-USCI 2 eme etage

location_facility: Istituto Clinico Humanitas UO Cardiologia Clinica e Interventistica

location_facility: Jessa Hospital Hartcentrum Hasselt Research Center

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: Region Uppsala, Akademiska Hospital Cardio and Pulmonary Medicine and Clinical Physiology

location_facility: University of Iowa Hospitals and Clinics

location_facility: CHU de Lille Service USIC, Institut Coeur Poumon

location_facility: St. Michael's Hospital, Unity Health Toronto

location_facility: Hospital Clinico San Carlos - Instituto Cardiovascular (ICV)


title: A Phase 1/2A, Open Label Dose Escalation and Expansion Study of Orally Administered CA-4948 as a Monotherapy in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

summary:
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally administered emavusertib (CA-4948) monotherapy in adult patients with Acute Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS).

Patients enrolling in the Phase 1 portion of the study must meet one of the following criteria prior to consenting to the study:

R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor
R/R AML with spliceosome mutations of SF3B1 or U2AF1
R/R hrMDS with spliceosome mutations of SF3B1 or U2AF1
Number of pretreatments: 1 or 2

The Phase 2a Dose Expansion will be in 3 Cohorts of patients:

R/R AML with FLT3 mutations who have been previously treated with a FLT3 inhibitor;
R/R AML with spliceosome mutations of SF3B1 or U2AF1; and
R/R hrMDS (IPSS-R score > 3.5) with spliceosome mutations of SF3B1 or U2AF1.

All patients above have had ≤ 2 lines of prior systemic anticancer treatment. In previous versions of this protocol there was a Phase 1b portion of the study, in which patients with AML or hrMDS received CA-4948 in combination with venetoclax. This part of the study is no longer open for enrollment.

lead_sponsor: Curis, Inc.

location_country:
Germany
France
Italy
Poland
United States
Spain
Czechia
Israel

location_facility: Service d'hématologie clinique CHU de Nic

location_facility: Marien Hospital Dusseldorf; Klinik fur Onkologie und Hamatologie, Palliativmedizin

location_facility: Hospital de la Santa Creu I Sant Pau (Neuvo Hospital)

location_facility: Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

location_facility: Centre de Recherche Clinique - Archet 1- 4ème étage - Aile A

location_facility: Universitatsklinikum Leipzig; Medizinische Klinik und Poliklinik I

location_facility: Instituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: The Ohio State University Wexner Medical Center - James Cancer Hospital

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists


title: Efficacy, Safety and Pharmacokinetics of 3 Doses of REC 0/0559 Eye Drops for the Treatment of Stage 2 (Moderate) and 3 (Severe) Neurotrophic Keratitis in Adult Patients

summary: A phase 2 study, aiming to evaluate the efficacy, safety and pharmacokinetics of REC 0/0559 in treatment of Neurotrophic Keratitis in Adult Patient in Europe and United States of America.

lead_sponsor: Recordati Rare Diseases

sponsor_collaborators:
Recordati Rare Diseases
Syneos Health

location_country:
Germany
Italy
Hungary
United Kingdom
United States
Spain
France

location_facility: Houston Eye Associates HEA - Gramercy Location

location_facility: Markusovszky University Teaching Hospital

location_facility: Fondazione PTV - Policlinico Tor Vergata

location_facility: Ludwig-Maximilians-Universitaet Muenchen LMU - Augenklinik

location_facility: University of Pecs - Dpt of Ophthalmology

location_facility: The University of Tennessee Health Science Center (UTHSC) - College of Medicine (COM) - Hamilton Eye Institute

location_facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Semmelweis University, Dept. of Ophthalmology

location_facility: Royal Liverpool University Hospital - St Paul's Clinical Eye Research Centre

location_facility: University of Szeged Department of Ophthalmology

location_facility: University of Maryland School of Medicine UMSOM

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: Mt. Sinai New York Eye and Ear Infirmary

location_facility: Cartuja Vision - Centro de Servicios Oftlamologicos

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: University of Michigan - Kellogg Eye Center

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari Clinica Oculistica


summary: The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

location_facility: Tennessee Oncology Tennessee Oncology (3)

location_facility: University Of California Los Angeles Santa Monica Location

title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

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

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Croatia
France
Slovenia
Colombia
Slovakia
Hungary
Switzerland
United States
India
China
Malaysia
Peru
Italy
Norway
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.

location_facility: University College London Hospitals NHS Foundation Trust ( Site 0445)

location_facility: Soroka Medical Center-Oncology ( Site 7031)

location_facility: Baltimore VA Medical Center ( Site 0054)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0103)

location_facility: MNPE Regional Center of Oncology ( Site 0134)

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 7041)

location_facility: Severance Hospital Yonsei University Health System ( Site 0201)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192)

location_facility: National Cheng Kung University Hospital ( Site 0208)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0004)

location_facility: Urology San Antonio Research ( Site 6010)

location_facility: Centro Hospitalar e Universitario de Coimbra ( Site 0306)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0442)

location_facility: Odense Universitetshospital ( Site 0403)

location_facility: Ukranian Center of TomoTherapy ( Site 0140)

location_facility: Pauls Stradins Clinical University Hospital ( Site 0073)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0099)

location_facility: Winthrop University Hospital ( Site 0069)

location_facility: Institutul Oncologic-Oncologie Medicala ( Site 0256)

location_facility: South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0086)

location_facility: SNPE National Cancer Institute ( Site 0136)

location_facility: Netherlands Cancer Institute (NKI) ( Site 0183)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0212)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0209)

location_facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (

location_facility: Froedtert and Medical College of Wisconsin ( Site 0022)

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106)

location_facility: Bay Pines VA Medical Center ( Site 0055)

location_facility: National Taiwan University Hospital ( Site 0210)

location_facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501)

location_facility: Sir Charles Gairdner Hospital ( Site 0223)

location_facility: Ege University Medical Faculty ( Site 0508)

location_facility: North Estonia Medical Centre Foundation ( Site 0081)

location_facility: Summit Medical Group Cancer Center ( Site 6008)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 0502)

location_facility: Ospedale Civile di Macerata ( Site 0190)

location_facility: New York University Perlmutter Cancer Center ( Site 0001)

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041)

location_facility: Darlington Memorial Hospital NHS Trust ( Site 0446)

location_facility: Seoul National University Bundang Hospital ( Site 0204)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0123)

location_facility: Tokyo Medical and Dental University Hospital ( Site 0601)

location_facility: Taipei Veterans General Hospital ( Site 0211)

location_facility: Betsi Cadwaladr University Health Board ( Site 0447)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139)

location_facility: University of Tsukuba Hospital ( Site 0605)

location_facility: Inova Schar Cancer Institute ( Site 6006)

location_facility: University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0097)

location_facility: Saint Francis Cancer Center ( Site 0026)

location_facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115)

location_facility: Carolina Urologic Research Center ( Site 0002)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153)

location_facility: Herlev og Gentofte Hospital. ( Site 0401)

location_facility: Korea University Anam Hospital ( Site 0205)

location_facility: Institutul Regional de Oncologie Iasi ( Site 0255)

location_facility: Kyiv City Clinical Oncology Center ( Site 0135)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0144)

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria ( Site 0305)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 0604)

location_facility: Hospital Universiti Sains Malaysia ( Site 0237)

location_facility: Hirosaki University Hospital ( Site 0602)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504)

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)

location_facility: New York Oncology Hematology P.C ( Site 0024)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0606)

location_facility: Taichung Veterans General Hospital ( Site 0213)

location_facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0302)

location_facility: West Virginia University - Charleston Area Medical Center ( Site 6003)

location_facility: Advance Urology and Laparoscopic Center ( Site 0281)

location_facility: Nottingham University Hospital NHS Trust ( Site 0250)

location_facility: Nagasaki University Hospital ( Site 0600)

location_facility: BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092)

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188)

location_facility: PAN American Center Oncologic ( Site 0280)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 0154)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152)

location_facility: Clinical oncology dispensary of Dnipro ( Site 0133)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0095)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 0252)

location_facility: Chungnam National University Hospital ( Site 0203)

location_facility: University Malaya Medical Centre ( Site 0236)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0088)

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

location_country:
Poland
Australia
Japan
Turkey
Chile
Czechia
France
Portugal
Hungary
Denmark
United States
Latvia
Ukraine
Romania
Malaysia
Estonia
Puerto Rico
Italy
Guatemala
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Israel


title: A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis

acronym: RAISE-XT

summary: The RAISE-XT study is an open-label extension study to evaluate the long-term efficacy, safety, and tolerability of zilucoplan in subjects with gMG who have previously participated in a qualifying Ra Pharmaceuticals sponsored zilucoplan study.

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: Ra Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
Norway
United Kingdom
Japan
United States
Spain
Canada
France


acronym: ADVANCE+

lead_sponsor: argenx

summary: This is an open-label long-term multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in adult patients with primary ITP.

location_facility:
Investigator Site 0390015
Investigator Site 0340007
Investigator Site 3590002
Investigator Site 0430003
Investigator site 9950012
Investigator Site 0010040
Investigator Site 0490010
Investigator Site 0390010
Investigator Site 3800006
Investigator Site 0330018
Investigator Site 0480011
Investigator Site 4200008
Investigator Site 0320002
Investigator Site 0900016
Investigator Site 0440008
Investigator Site 0340004
Investigator Site 0900013
Investigator Site 0340014
Investigator Site 0430002
Investigator Site 0810021
Investigator Site 0900006
Investigator Site 0070012
Investigator Site 0480013
Investigator Site 0320012
Investigator Site 0010042
Investigator Site 0900019
Investigator Site 0340009
Investigator Site 0070007
Investigator Site 0340006
Investigator Site 0330008
Investigator Site 0330009
Investigator Site 0810017
Investigator site 9950007
Investigator Site 0070008
Investigator Site 0360006
Investigator Site 0390014
Investigator Site 0900003
Investigator Site 0320011
Investigator Site 0480014
Investigator Site 0310006
Investigator Site 0900009
Investigator Site 0330016
Investigator Site 0010045
Investigator Site 0390009
Investigator Site 0810015
Investigator Site 4200001
Investigator Site 0900010
Investigator Site 0900017
Investigator Site 0070006
Investigator Site 0900015
Investigator Site 0360014
Investigator Site 0480026
Investigator Site 0810014
Investigator Site 0070010
Investigator Site 0340015
Investigator Site 0390011
Investigator Site 0310005
Investigator site 9950008
Investigator Site 0360010
Investigator site 9950011
Investigator Site 0340011
Investigator Site 0390018
Investigator Site 0390019
Investigator Site 0900007
Investigator Site 0900004
Investigator Site 0360004
Investigator Site 0070013
Investigator Site 0010037
Investigator Site 0490008
Investigator Site 0340013
Investigator Site 4200006
Investigator Site 0480012
Investigator Site 0320014
Investigator Site 0070015
Investigator site 9950009
Investigator Site 0810010
Investigator Site 0440012
Investigator Site 0390020
Investigator Site 0360015
Investigator Site 4200007
Investigator Site 0810016
Investigator Site 0340012
Investigator Site 0810022
Investigator Site 0390016
Investigator Site 0810023
Investigator Site 3590001
Investigator Site 0810018

title: A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Japan
Netherlands
Austria
Belgium
United States
Spain
Turkey
Czechia
Ukraine
Bulgaria
Georgia
Russian Federation
France


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)

summary: The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

lead_sponsor: Alexion Pharmaceuticals, Inc.

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


lead_sponsor: Sanofi

summary:
Primary Objective:

To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole.

Secondary Objectives:

To assess the proportion of participants with a relative decrease from Baseline in percentage of positive tumor cells tested by immunohistochemistry greater than or equal to (>=) 50 percent (%) (Ki67 >=50%) in the three treatment arms.
To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms.
To assess safety in the three treatment arms.

location_facility:
Investigational Site Number 0560002
Investigational Site Number 7240001
Investigational Site Number 8040002
Investigational Site Number 7240005
Investigational Site Number 8400007
Investigational Site Number 8400012
Investigational Site Number 8400010
Investigational Site Number 8400016
Investigational Site Number 2500002
Investigational Site Number 0560001
Investigational Site Number 6430007
Investigational Site Number 2500001
Investigational Site Number 6430002
Investigational Site Number 6430004
Investigational Site Number 8040001
Investigational Site Number 7240003
Investigational Site Number 3920003
Investigational Site Number 2500004
Investigational Site Number 8400005
Investigational Site Number 8400014
Investigational Site Number 3800002
Investigational Site Number 6430006
Investigational Site Number 8040004
Investigational Site Number 7240002
Investigational Site Number 3800004
Investigational Site Number 3800001
Investigational Site Number 8400018
Investigational Site Number 8040005
Investigational Site Number 3920002
Investigational Site Number 2500003
Investigational Site Number 6430003
Investigational Site Number 3920001

title: Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer

location_country:
Italy
Japan
Belgium
United States
Spain
Ukraine
Puerto Rico
Russian Federation
France


acronym: EMBER

lead_sponsor: Eli Lilly and Company

summary: The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: University of Rochester School of Medicine

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Peggy and Charles Stephenson Oklahoma Cancer Center

location_facility: Institut de Cancérologie de l'Ouest Centre René Gauducheau

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: South Texas Accelerated Research Therapeutics (START)

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Univ of California Irvine College of Medicine

location_facility: ICANS_Institut de Cancerologie Strasbourg Europe

location_facility: Fundación Instituto Valenciano de Oncología

title: EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

location_country:
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Taiwan
France


title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects With Axial Spondyloarthritis Followed by a Remission-Withdrawal Period

acronym: SELECT-AXIS 2

summary:
This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently.

The main objectives of this protocol are:

To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2).
To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2).
To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2).
To evaluate the maintenance of disease control after withdrawal of upadacitinib.

ReferenceCitation: Deodhar A, Van den Bosch F, Poddubnyy D, Maksymowych WP, van der Heijde D, Kim TH, Kishimoto M, Blanco R, Duan Y, Li Y, Pangan AL, Wung P, Song IH. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2022 Jul 30;400(10349):369-379. doi: 10.1016/S0140-6736(22)01212-0.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: van der Heijde D, Baraliakos X, Sieper J, Deodhar A, Inman RD, Kameda H, Zeng X, Sui Y, Bu X, Pangan AL, Wung P, Song IH. Efficacy and safety of upadacitinib for active ankylosing spondylitis refractory to biological therapy: a double-blind, randomised, placebo-controlled phase 3 trial. Ann Rheum Dis. 2022 Nov;81(11):1515-1523. doi: 10.1136/ard-2022-222608. Epub 2022 Jul 4.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Leiden University - Leiden Repository

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
United States
Ukraine
Belgium
China
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: Juntendo University Hospital /ID# 214929

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 214731

location_facility: Okinawa Prefectural Chubu Hospital /ID# 215575

location_facility: LLC Family Outpatient Clinic № /ID# 214455

location_facility: Chung Shan Medical University Hospital /ID# 214018

location_facility: Hospital Universitario y Politecnico La Fe /ID# 214966

location_facility: Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 215652

location_facility: MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 214261

location_facility: Nort-Western State Medical University n.a. Mechnikov /ID# 214454

location_facility: First Affiliated Hospital of Kunming Medical University /ID# 217945

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214211

location_facility: MNI KRC Kyiv Regional Clinical Hospital /ID# 214156

location_facility: CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 214158

location_facility: CPCLIN - Centro de Pesquisas Clínicas /ID# 215175

location_facility: Immanuel Kant Baltic Federal University /ID# 218259

location_facility: Kaohsiung Veterans General Hos /ID# 214332

location_facility: Greater Chicago Specialty Physicians /ID# 216213

location_facility: Medical Center LLC Institute of Rheumatology /ID# 214146

location_facility: Universitair Ziekenhuis Leuven /ID# 215006

location_facility: Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 215055

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 215176

location_facility: Sweet Hope Research Specialty Inc /ID# 215931

location_facility: The First Affiliated Hospital of Shantou University Medical College /ID# 217883

location_facility: The First Affiliated Hospital of Soochow University /ID# 216607

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214295

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 215183

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214207

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont /ID# 215182

location_facility: Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 215805

location_facility: MI Kryvyi Rih City Clinical Hospital No.2 /ID# 214152

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 214488

location_facility: PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 214151

location_facility: Istanbul University Cerrahpasa Faculty of Medicine /ID# 214895

location_facility: Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 214148

location_facility: CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 215277

location_facility: National Hospital Organization Osaka Minami Medical Center /ID# 214205

location_facility: Narodny ustav reumatickych chorob /ID# 214674

location_facility: Municipal Non-Commercial Enterprise Odesa Regional Clinical Hospital of the Od /ID# 214159

location_facility: Tel Aviv Sourasky Medical Center /ID# 216956

location_facility: National Hospital Organization Asahikawa Medical Center /ID# 214930

location_facility: Centre de Recherche Musculo-Squelettique /ID# 215096

location_facility: Japanese Red Cross Okayama Hospital /ID# 214732

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 214865

location_facility: Peking Union Medical College Hospital /ID# 216545

location_facility: Trinity Universal Research Associates, Inc /ID# 215189

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 214501

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 214967

location_facility: Biopharma Informatic - Park Row /ID# 215907

location_facility: Hanyang University Seoul Hospital /ID# 214297

location_facility: Oregon Health and Science University /ID# 216446

location_facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 215093

location_facility: Rheuma Research Lausitz, Dr. Mario Sutowicz /ID# 214218

location_facility: Orenburg State Medical University /ID# 214408

location_facility: West Texas Clinical Research /ID# 215928

location_facility: AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 214354

location_facility: Trinity Universal Research Associates - Carrollton /ID# 214948

location_facility: CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 214147

location_facility: Nasz Lekarz Przychodnie Medyczne /ID# 214352

location_facility: Univerzitna nemocnica Bratislava Nemocnica Stare Mesto /ID# 214675

location_facility: Seoul National University Hospital /ID# 214532

location_facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 214208

location_facility: Hacettepe Universitesi Tip Fak /ID# 214898

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 215306

location_facility: MUDr. Zuzana Cizmarikova s.r.o. /ID# 215220

location_facility: Multifield Medical Centre of ONMU /ID# 214149

location_facility: Diagnostic consultative center 17 Sofia /ID# 214808

location_facility: Gachon University Gil Medical Center /ID# 214534

location_facility: Percuro Clinical Research, Ltd /ID# 215302

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 215186

location_facility: Research Institute of Rheumatology named after V.A. Nasonova /ID# 214459

location_facility: Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 214282

location_facility: Hospital Universitario Reina Sofia /ID# 214968

location_facility: Medizinische Hochschule Hannover /ID# 214209

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 214784

location_facility: Organizacion Medica de Investigacion (OMI) /ID# 214557

location_facility: Clinical Pharmacology Study Group /ID# 215293

location_facility: Omsk Regional Clinic Hospital /ID# 214464

location_facility: CenterPointe Institute of Research /ID# 215793

location_facility: Arizona Arthritis & Rheumatology Associates, P.C. /ID# 215282

location_facility: Hyogo College of Medicine College Hospital /Id# 215638

location_facility: Khmelnytskyi Regional Hospital /ID# 214153

location_facility: Medical Center CONSILIUM MEDICAL /ID# 216234

location_facility: Revmatologicky ustav v Praze /ID# 215154

location_facility: Rheumatology and Pulmonary Clinic /ID# 214946

location_facility: Chelyabinsk Regional Clinical Hospital /ID# 214463

location_facility: Kyunghee University Hospital at Gangdong /ID# 214296

location_facility: Ryazan State Medical University named after academician I.P. Pavlov /ID# 214418

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 214965

location_facility: NYU Langone Orthopedic Center /ID# 215594

location_facility: Inland Rheum & Osteo Med Grp /ID# 215807

location_facility: Hospital Universitario La Paz /ID# 216032

location_facility: The first affiliated hospital of bengbu medical college /ID# 216609

location_facility: Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 214212

location_facility: St.Luke's International Hospital /ID# 215414

location_facility: Ternopil University Hospital /ID# 214705

location_facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 215181

location_facility: Kyiv Railway Clinical Hosp No.2 /ID# 214779

location_facility: Guangdong Provincial People's Hospital /ID# 216645

location_facility: Kazan State Medical University /ID# 214421

location_facility: Nagasaki University Hospital /ID# 215947

location_facility: Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 215184

location_facility: Huashan Hospital, Fudan University /ID# 216646

location_facility: CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 215217

location_facility: The First Affiliated Hospital of BaoTou Medical College, Inner Mongolia Universi /ID# 216612

location_facility: Innovation Medical Research Center /ID# 216068

location_facility: China Medical University Hospital /ID# 214019

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 215187

location_facility: Applied Medical Informatics Research Inc. (AMIR) /ID# 215303

location_facility: MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 214145

location_facility: Revmacentrum MUDr. Mostera, s.r.o. /ID# 215161

location_facility: State Institution L.T. Malaya Therapy National Institute of the NAMS of Ukraine /ID# 214155

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 214458

location_facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 214556

location_facility: Universitaetsklinikum Erlangen /ID# 214281

location_facility: Matsuyama Red Cross Hospital /ID# 216021

location_facility: The Chaim Sheba Medical Center /ID# 215854

location_facility: EDUMED Educacao em Saude S/S L /ID# 215111

location_facility: Mugla Sitki Kocman University Medical Faculty /ID# 215358

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 215113

location_facility: Wayne State University Health Center /ID# 215930

location_facility: Centro de Investigaciones Medicas Tucuman /ID# 214559

location_facility: Far Eastern Memorial Hospital /ID# 215384

location_facility: Newport Huntington Medical Group /ID# 216281

location_facility: MNI City Multidisciplinary Hospital #18 /ID# 214154

location_facility: Barwon Rheumatology Services /ID# 215508

location_facility: City Clinical Hospital n.a. O.M. Filatov /ID# 214486

location_facility: Hokkaido University Hospital /ID# 215221

location_facility: ETYKA-Osrodek Badan Klinicznych /ID# 215572

location_facility: Alliance Biomedical Ural Group /ID# 214457


acronym: INDIGO

lead_sponsor: Institut de Recherches Internationales Servier

summary: Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: The University of Utah, Huntsman Cancer Hospital

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Western General Hospital Edinburgh - PPDS

location_facility: Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Washington University School of Medicine

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: University of California Irvine - Hospital

location_facility: University of Pittsburgh Hillman Cancer Center

location_facility: University Hospital, Kyoto Prefectural University of Medicine

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

location_country:
Germany
France
Italy
United Kingdom
Japan
Netherlands
Switzerland
United States
Spain
Canada
Israel


lead_sponsor: Bioverativ, a Sanofi company

summary:
Primary Objective:

- To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm.

Secondary Objectives:

To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes.
To evaluate BIVV001 consumption for the prevention and treatment of bleeding episodes.
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes.
To evaluate the effect of BIVV001 prophylaxis on Quality of Life outcomes.
To evaluate the efficacy of BIVV001 for perioperative management.
To evaluate the safety and tolerability of BIVV001 treatment.
To assess the pharmacokinetics (PK) of BIVV001 based on the 1-stage activated partial thromboplastin time (aPTT) and 2-stage chromogenic coagulation factor VIII (FVIII) activity assays.

location_facility:
Investigational Site Number 283
Investigational Site Number 282
Investigational Site Number 601
Investigational Site Number 304
Investigational Site Number 202
Investigational Site Number 121
Investigational Site Number 321
Investigational Site Number 902
Investigational Site Number 435
Investigational Site Number 917
Investigational Site Number 532
Investigational Site Number 906
Investigational Site Number 425
Investigational Site Number 421
Investigational Site Number 521
Investigational Site Number 139
Investigational Site Number 284
Investigational Site Number 422
Investigational Site Number 603
Investigational Site Number 122
Investigational Site Number 920
Investigational Site Number 172
Investigational Site Number 314
Investigational Site Number 171
Investigational Site Number 919
Investigational Site Number 600
Investigational Site Number 531
Investigational Site Number 908
Investigational Site Number 424
Investigational Site Number 402
Investigational Site Number 426
Investigational Site Number 581
Investigational Site Number 137
Investigational Site Number 281
Investigational Site Number 303
Investigational Site Number 911
Investigational Site Number 641
Investigational Site Number 921
Investigational Site Number 181
Investigational Site Number 401
Investigational Site Number 423
Investigational Site Number 205
Investigational Site Number 312
Investigational Site Number 161
Investigational Site Number 136
Investigational Site Number 302

status: Completed

title: A Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients ≥12 Years of Age With Severe Hemophilia A

location_country:
Germany
Argentina
Australia
Brazil
Japan
Canada
France
Hungary
United States
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria

status_simplified: Completed


title: HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)

summary: This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Ireland
Poland
Argentina
Australia
Japan
Croatia
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
United States
Latvia
Belgium
Peru
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Israel


acronym: CAPELLA

lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen (functional monotherapy) in people living with HIV (PLWH) with multi-drug resistance (MDR).

ReferenceType: background

ReferenceCitation: Segal-Maurer S, Castagna A, Berhe M, et al. Potent Antiviral Activity of Lenacapavir in Phase 2/3 in Heavily ART-Experienced PWH [Abstract 127]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2021 March 6-10.

ReferenceCitation: Segal-Maurer S, DeJesus E, Stellbrink HJ, Castagna A, Richmond GJ, Sinclair GI, Siripassorn K, Ruane PJ, Berhe M, Wang H, Margot NA, Dvory-Sobol H, Hyland RH, Brainard DM, Rhee MS, Baeten JM, Molina JM; CAPELLA Study Investigators. Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2022 May 12;386(19):1793-1803. doi: 10.1056/NEJMoa2115542.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: Hospital Dr. Salvador Bienvenido Gautier

location_facility: Bamrasnaradura Infectious Diseases Institute

location_facility: Atrium Health- Infectious Disease Consultants

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: North Texas Infectious Diseases Consultants, P.A.

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Faculty of Medicine, Khon Kaen University

location_facility: Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele

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

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Instituto Dominicano de Estudios Virologicos (IDEV)

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Hospital Universitari Germans Trías i Pujol

location_facility: AIDS Healthcare Foundation - South Beach

location_facility: North Shore University Hospital/Division of Infectious Diseases

location_facility: Taoyuan General Hospital, Ministry of Health and Welfare

location_facility: Faculty of Medicine Siriraj Hospital, Mahidol University

location_facility: Durban International Clinical Research Site, Enhancing Care Foundation

location_facility: Clinique de médecine urbaine du Quartier Latin

location_facility: Maple Leaf Research/Maple Leaf Medical Clinic

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie

location_facility: UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1

location_facility: AIDS Arms, Inc. DBA Prism Health North Texas

location_facility: Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania

location_facility: Universitätsklinikum Frankfurt, Medizinische Klinik II

title: A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance

location_country:
Germany
Italy
Japan
United States
Spain
Thailand
Dominican Republic
South Africa
Taiwan
Canada
France


title: A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers

summary:
Phase Ia - Explore safety and establish the maximum tolerated dose (MTD)/recommended dose levels for phase Ib expansion phase of BI 905711 based on the frequency of patients experiencing dose limiting toxicities (DLTs) during the MTD evaluation period. The MTD evaluation period is defined as the first two treatment cycles (from first dose administration until the day preceding the third dose administration or end of REP in case of discontinuation before start of Cycle 3).

Phase Ia - Explore pharmacokinetics/pharmacodynamics, and efficacy to guide the determination of a potentially effective dose range for phase Ib in the absence of MTD.

Phase Ib - Evaluate efficacy and safety of BI 905711 at a potentially effective dose range and determine the Recommended Phase 2 Dose (RP2D)

ReferenceCitation: Garcia-Martinez JM, Wang S, Weishaeupl C, Wernitznig A, Chetta P, Pinto C, Ho J, Dutcher D, Gorman PN, Kroe-Barrett R, Rinnenthal J, Giragossian C, Impagnatiello MA, Tirapu I, Hilberg F, Kraut N, Pearson M, Kuenkele KP. Selective Tumor Cell Apoptosis and Tumor Regression in CDH17-Positive Colorectal Cancer Models using BI 905711, a Novel Liver-Sparing TRAILR2 Agonist. Mol Cancer Ther. 2021 Jan;20(1):96-108. doi: 10.1158/1535-7163.MCT-20-0253. Epub 2020 Oct 9.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Japan
Belgium
United States
China
Korea, Republic of
Spain
France

location_facility: START South Texas Accelerated Research Therapeutics, LLC

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University


title: A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab in Addition to R-CHOP or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) - First-MIND

summary: This is an open-label, randomized, multicentre study to evaluate safety and preliminary efficacy of the human anti-CD19 antibody Tafasitamab in addition to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) or Tafasitamab and Lenalidomide in addition to R-CHOP in adult patients with newly diagnosed, previously untreated Diffuse Large B-cell Lymphoma (DLBCL).

lead_sponsor: MorphoSys AG

location_country:
Germany
Italy
Portugal
Austria
Belgium
United States
Spain
Czechia
France

location_facility:
MorphoSys Research Site
Medizinische Universtät Innsbruck


title: A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Anti-Cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) - DREAMM 5

summary: B-cell maturation antigen (BCMA) is a target present on tumor cells in participants with multiple myeloma. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma. The Platform design incorporates a single master protocol, where multiple treatment combinations, as sub-studies, will be evaluated simultaneously.

ReferenceCitation: Hosoya H, Sidana S. Antibody-Based Treatment Approaches in Multiple Myeloma. Curr Hematol Malig Rep. 2021 Apr;16(2):183-191. doi: 10.1007/s11899-021-00624-6. Epub 2021 Mar 17.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

ReferenceCitation: Nooka AK, Weisel K, van de Donk NW, Routledge D, Otero PR, Song K, Quach H, Callander N, Minnema MC, Trudel S, Jackson NA, Ahlers CM, Im E, Cheng S, Smith L, Hareth N, Ferron-Brady G, Brouch M, Montes de Oca R, Paul S, Holkova B, Gupta I, Kremer BE, Richardson P. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design. Future Oncol. 2021 Jun;17(16):1987-2003. doi: 10.2217/fon-2020-1269. Epub 2021 Mar 8.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_normalized: University of Melbourne - Minerva Access

publisher_dissemination: Future Science Ltd

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Israel
Norway
Australia
Brazil
Japan
Mexico
Netherlands
Sweden
United States
Korea, Republic of
Spain
Greece
Canada
Russian Federation
France


title: A Randomized, Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

summary: The purpose of the MycarinGstudy is to evaluate the long-term safety, tolerability and long-term efficacy of rozanolixizumab in study participants with generalized myasthenia gravis (MG).

lead_sponsor: UCB Biopharma SRL

location_country:
Germany
Italy
Poland
Denmark
Japan
United States
Spain
Taiwan
Czechia
Canada
Russian Federation
France