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:

•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 in the NSQ NSCLC population

Secondary Objectives:

To assess the safety and tolerability of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed
To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy, with or without pemetrexed 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 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

location_country:
Spain
Hungary
France
United States
Chile
Israel
Czechia

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

location_facility: SzSzBMK, Jósa András Oktatókórház Sóstói út 62_Investigational Site Number :3480007

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

location_facility: CHRU BREST 5 Avenue Foch_Investigational Site Number :2500003

location_facility: Renovatio Clinical_Investigational Site Number :8400004

location_facility: KU Medical Center_Investigational Site Number :8400002

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

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

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

location_facility: Virginia Cancer Specialists_Investigational Site Number :8400001

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

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

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

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

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


type: EudraCT Number

type: Other Identifier

title: A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours.

summary: The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Revenko A, Carnevalli LS, Sinclair C, Johnson B, Peter A, Taylor M, Hettrick L, Chapman M, Klein S, Solanki A, Gattis D, Watt A, Hughes AM, Magiera L, Kar G, Ireland L, Mele DA, Sah V, Singh M, Walton J, Mairesse M, King M, Edbrooke M, Lyne P, Barry ST, Fawell S, Goldberg FW, MacLeod AR. Direct targeting of FOXP3 in Tregs with AZD8701, a novel antisense oligonucleotide to relieve immunosuppression in cancer. J Immunother Cancer. 2022 Apr;10(4). pii: e003892. doi: 10.1136/jitc-2021-003892.

ipd_sharing: Yes

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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
United States
Spain
Canada
France

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Drug

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

lead_sponsor: Takeda

source: euctr

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

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

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

location_facility: West China Second University Hospital, Sichuan Univesity

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

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

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

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

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

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN

location_facility: Princess Maxima Center for Pediatric Oncology - PIN

location_facility: Hospital Universitario Virgen del Rocio - PPDS

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

location_facility: Children's Hospital of Chongqing Medical University

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

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

location_facility: Childrens Medical Center Research Institute at UT Southwestern

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

location_facility: Ospedale Infantile Regina Margherita - INCIPIT - PIN

location_facility: Hospital Infantil Universitario Nino Jesus - PIN

location_facility: Cincinnati Children's Hospital Medical Center - PIN

location_facility: SPZOZ Centralny Szpital Kliniczny UM w Lodzi

location_facility: Severance Hospital Yonsei University Health System

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

location_facility: Cambridge University Hospitals NHS Foundation Trust

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

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: The Second Hospital of Anhui Medical University

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Assistance Publique Hopitaux de Marseille

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

location_facility: Children's Hospital of Soochow University

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

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

location_facility: The Affiliated Hospital of Qingdao University

location_facility: The Affiliated Hospital of Guizhou Medical University

summary:
This study is about an anticancer drug called ponatinib which is a tyrasine 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, a minitablet form of the ponatinib 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.


status: Active, not recruiting

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

lead_sponsor: Merck Sharp & Dohme LLC

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.

enrollment_type: Actual

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

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0677)

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

location_facility: Hospital Universitario Austral ( Site 0126)

location_facility: Queensland Children s Hospital ( Site 0804)

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

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

location_facility: Cancercare Rondebosch Oncology ( Site 0575)

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

location_facility: Skanes Universitetssjukhus Lund. ( Site 0525)

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

location_facility: Univerzitetska decja klinika ( Site 0782)

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

location_facility: Dmitry Rogachev National Research Center ( Site 0550)

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

location_facility: Istanbul Universitesi Onkoloji Enstitusu ( Site 0600)

location_facility: Unidad Nacional de Oncologia Pediatrica ( Site 0176)

location_facility: Hospital de Niños Ricardo Gutiérrez ( Site 0125)

location_facility: Klinika za djecje bolesti Zagreb ( Site 0725)

location_facility: Starship Childrens Hospital ( Site 0826)

location_facility: Seoul National University Hospital ( Site 0875)

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu ( Site 0410)

location_facility: Mary Crowley Cancer Research Center ( Site 0107)

location_facility: Royal Childrens Hospital Melbourne ( Site 0802)

location_facility: Ospedale Infantile Regina Margherita ( Site 0412)

location_facility: Ege Universitesi Tip Fakultesi ( Site 0601)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 0603)

location_facility: Klinicki bolnicki centar Rijeka ( Site 0726)

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

location_facility: Fakultni Nemocnice Brno Bohunice ( Site 0651)

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

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

location_facility: Fakultni nemocnice v Motole ( Site 0650)

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.


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.

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

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)

design_allocation: Randomized

ipd_sharing: No

lead_sponsor: Balt USA

location_country:
Germany
United States
Spain
France

location_facility: Penn State Health Hershey Medical Center

intervention_type: Other


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:
Brazil
Spain
Italy
United Kingdom
Mexico
France
Belgium
Germany

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

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Ospedale A. Manzonidi Lecco - ASST Lecco

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: Centro de Prevención y Rehabilitación de Enfermedades Pulmon

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

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

location_facility: Centro Oncológico de Roraima - CECOR - NAP

location_facility: Universitätsmedizin Mannheim Ruprecht-Karls-Universität Heid

location_facility: Ospedale di Vittorio Veneto - Medecina generale


ipd_sharing: Undecided

acronym: MIT-E

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

lead_sponsor: PTC Therapeutics

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

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: Karolinska University hospital, Astrid Lindgrens Children Hospital

location_facility: Hospital Ruber Internacional, Neurology Department, Epilepsy Program

location_facility: Alberta Children's Hospital, University of Calgary

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

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

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

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

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Pediatric Genetics Clinic (Main MGH Hospital)

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

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

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

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.


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

location_country:
Spain
United Kingdom
Canada
United States
France
Netherlands


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.

lead_sponsor: Albireo

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

location_facility: NewYork-Presbyterian Morgan Stanley Children's Hospital

location_facility: Birmingham Women´s and Children´s Hospital

location_facility: University Medical Center Hamburg-Eppendorf UKE

location_facility: Semmelweis Egyetem I.sz Gyermekgyógyászati Klinika

location_facility: University Children´s Hospital Tuebingen

location_facility: Nemours/Alfred I. duPont Hospital for Children

location_facility: Istanbul University, Istanbul Medical Faculty

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

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

location_facility: Schneider Children´s Medical Center of Israel

location_facility: Seoul National University Children's Hospital

location_facility: Hacettepe University Ihsan Dogramaci Childrens Hospital

location_facility: Necker University Hospital - Enfants malades

location_facility: UCSF Benioff Children's Hospital San Francisco

location_facility: University of Michigan Children's Hospital

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

location_facility: Guangzhou Women and Children's Medical Center


title: A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

summary: The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Inc.

location_country:
United States
United Kingdom
France

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Beatson West of Scotland Cancer Centre - PPDS

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: University of Arkansas For Medical Sciences

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: University of Texas MD Anderson Cancer Center

location_facility: ICANS - Institut de cancérologie Strasbourg Europe

location_facility: Arizona Clinical Research Center - Hunt - PPDS

location_facility: Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

location_facility: Winship Cancer Institute, Emory University

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Chattanooga's Program In Women's Oncology

location_facility: Georgia Cancer Center at Augusta University


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

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

location_facility: University of Florida Health, Jacksonville

location_facility: Hospital Universitario Vírgen de la Victoria

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

location_facility: Tianjin Medical University General Hospital

location_facility: Complejo Hospitalario Universitario A Coruna

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

location_facility: Skane University Hospital, Department of Cardiology

location_facility: Duke Heart Center at Southeastern Health

location_facility: Ziekenhuis Oost-Limburg Study Center Intensive Care

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: Universitatsspital Basel Department of Cardiology

location_facility: Hospital Universitario 12 de Octubre, Residencia general

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

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

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

location_facility: Azienda Ospedaliero-Universitaria di Parma Cardiologia

location_facility: William Osler Health System - Brampton Civic Hospital

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

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

location_facility: First Affiliated Hospital of Xi'an Jiaotong University

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

location_facility: Beijing Anzhen Hospital, Capital Medical University

location_facility: Istituto Clinico Humanitas UO Cardiologia Clinica e Interventistica

location_facility: Ascension St. John Clinical Research Institute

location_facility: Jessa Hospital Hartcentrum Hasselt Research Center

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

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Algemeen Stedelijk Ziekenhuis (ASZ) Study Center Cardiology

location_facility: University of Iowa Hospitals and Clinics

location_facility: University Hospital Antwerp Cardiology Department - Clinical Trials

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

location_facility: CHU de Lille Service USIC, Institut Coeur Poumon

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

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


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

location_country:
Spain
Italy
United Kingdom
Hungary
United States
France
Germany

location_facility: University of Szeged Department of Ophthalmology

location_facility: University of Pecs - Dpt of Ophthalmology

location_facility: Ludwig-Maximilians-Universitaet Muenchen LMU - Augenklinik

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

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: Semmelweis University, Dept. of Ophthalmology

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari Clinica Oculistica

location_facility: Houston Eye Associates HEA - Gramercy Location

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Cartuja Vision - Centro de Servicios Oftlamologicos

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

location_facility: University of Maryland School of Medicine UMSOM

location_facility: Markusovszky University Teaching Hospital


title: A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors

summary: The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB099280 in participants with select solid tumors

ipd_sharing_description: There is no plan to share data

lead_sponsor: Incyte Corporation

location_country:
Australia
Ukraine
United States
France
Belgium
Japan
Bulgaria

location_facility: Institut Jules Bordet Clinical Trials Conduct Unit

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Rmi Sumy Regional Clinical Oncology Dispensary

location_facility: Ci of Healthcare Regional Clinical Specialized Dispensary of the Radiation Protection

location_facility: Mi Kryviy Rih Center of Dnipropetrovsk Regional Council

location_facility: Institut de Cancerologie de L Ouest - Site Paul Papin


intervention_type: Radiation

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)

type: Registry Identifier

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

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0136)

location_facility: North Estonia Medical Centre Foundation ( Site 0081)

location_facility: Monash Health-Monash Medical Centre ( Site 0216)

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

location_facility: Ukranian Center of TomoTherapy ( Site 0140)

location_facility: Sir Charles Gairdner Hospital ( Site 0223)

location_facility: Odense Universitetshospital ( Site 0403)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0209)

location_facility: Korea University Anam Hospital ( Site 0205)

location_facility: University Malaya Medical Centre ( Site 0236)

location_facility: Herlev og Gentofte Hospital. ( Site 0401)

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

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

location_facility: Seoul National University Bundang Hospital ( Site 0204)

location_facility: CNPE "Regional Center of Oncology" ( Site 0134)

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

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

location_facility: Pauls Stradins Clinical University Hospital ( Site 0073)

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

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

location_facility: Hospital Universiti Sains Malaysia ( Site 0237)

location_facility: Clinical oncology dispensary of Dnipro ( Site 0133)

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

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

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

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

location_facility: Hirosaki University Hospital ( Site 0602)

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

location_facility: National Cheng Kung University Hospital ( Site 0208)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 0502)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0097)

location_facility: University of Tsukuba Hospital ( Site 0605)

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

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

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

location_facility: Saint Francis Cancer Center ( Site 0026)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0099)

location_facility: Institutul Regional de Oncologie Iasi ( Site 0255)

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

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

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

location_facility: Chungnam National University Hospital ( Site 0203)

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

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503)

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

location_facility: National Taiwan University Hospital ( Site 0210)

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

location_facility: Advance Urology and Laparoscopic Center ( Site 0281)

location_facility: Baltimore VA Medical Center ( Site 0054)

location_facility: Nottingham University Hospital NHS Trust ( Site 0250)

location_facility: Kyiv City Clinical Oncology Center ( Site 0135)

location_facility: Winthrop University Hospital ( Site 0069)

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

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

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

location_facility: Bay Pines VA Medical Center ( Site 0055)

location_facility: Ospedale Civile di Macerata ( Site 0190)

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

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0606)

location_facility: Ege University Medical Faculty ( Site 0508)

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

location_facility: Carolina Urologic Research Center ( Site 0002)

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

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

location_facility: Taichung Veterans General Hospital ( Site 0213)

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

location_facility: Nagasaki University Hospital ( Site 0600)

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

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

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

location_facility: Betsi Cadwaladr University Health Board ( Site 0447)

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

location_facility: Soroka Medical Center-Oncology ( Site 7031)

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

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

location_facility: Inova Schar Cancer Institute ( Site 6006)

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

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

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

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

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

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

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

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

location_facility: PAN American Center Oncologic ( Site 0280)

location_facility: Taipei Veterans General Hospital ( Site 0211)

location_facility: Darlington Memorial Hospital NHS Trust ( Site 0446)

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.


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


acronym: Piranga

title: A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

lead_sponsor: Hoffmann-La Roche

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).

location_country:
Taiwan
Hong Kong
Spain
United Kingdom
New Zealand
Canada
Thailand
Korea, Republic of
United States
Chile
China
France
Bulgaria

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital; Pharmacy

location_facility: China Medical University Hospital; Internal Medicine

location_facility: Hopital de la Croix-Rousse - Groupement Hospitalier Nord; Pharmacie / Secteur Essais Cliniques

location_facility: University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology

location_facility: Hopital Brabois Adultes; Service Médecine Interne Hématologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Asan Medical Center / Clinical Trial Center

location_facility: King College Hospital NHS Foundation Trust

location_facility: NYU Langone Medical Center; Clinical Laboratories

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Inje University Busan Paik Hospital; Clinical Trial Center

location_facility: Hospital Alvaro Cunqueiro; Servicio de Farmacia. Planta -1

location_facility: Tokuda Hospital Sofia; Hematology department

location_facility: Nanfang Hospital, Southern Medical University

summary: This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.


acronym: ADVANCE+

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.

lead_sponsor: argenx

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

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

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.


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

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


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)

summary: The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

lead_sponsor: Cerevel Therapeutics, LLC

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

location_facility:
Kraków
Tampa, Florida
Prague,
Muenster
Springub
Houston, Texas
Sevilla
Lodz
Asheville, North Carolina
Haifa
Shoham
Barcelona
Toronto, Ontario
Columbus, Ohio
Jerusalem
Boca Raton, Florida
Pasadena, California
Adventura, Florida
Sofia
Padova
Denver, Colorado
Woolloongabba, Queensland
Terrassa
Canada, Ville De Quebec
Philadelphia, Pennsylvania
Georgetown, Texas
Bad Homburg
Medical center VITA1, Pleven
Petah Tiqva
Little Rock, Arkansas
Stadtroda
Pheonix, Arizona
Atlantis, Florida
Lublin
Raleigh, North Carolina
Zaporozhya
Los Angeles, California
United States, Washington
Boulevard Pinel, Bron
Chicago, Illinois
Reseda, California
Duesseldorf,
Winfield, Illinois
Ramat Gan
Dayton, Ohio
Augusta, Georgia
Durham, North Carolina
Fountain Valley, California
Haag in Oberbayern
Ottawa, Ontario
Milano
Multiprofile Hospital, Sofia
Poliklinika, Chocen,
Creteil
Grenoble cedex
Virginia Beach, Virginia
Nîmes cedex
Boston, Massachusetts
Rychnov nad Kněžnou
Erina, New South Wales
Warsaw
Pisa
Toledo, Ohio
Lubbock, Texas
East Lansing, Michigan
Katowice
Elche
Ashkelon
Zaporiizhzhya
Kharkiv
Birmingham, Alabama
Ormond Beach, Florida
Scarborough, Maine
Rome
Valencia
Madrid
Englewood, Colorado
Parkville, Victoria
Dnipro
Farmington Hills, Michigan
Pleven
Kansas City, Kansas
Tel Aviv
Burlington, Vermont
Las Vegas, Nevada
Lexington, Kentucky


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

lead_sponsor: Sanofi

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

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

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

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.


acronym: EMBER

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

lead_sponsor: Eli Lilly and Company

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

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

location_facility: Peggy and Charles Stephenson Oklahoma Cancer Center

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Univ of California Irvine College of Medicine

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: ICANS_Institut de Cancerologie Strasbourg Europe

location_facility: South Texas Accelerated Research Therapeutics (START)

location_facility: University of Rochester School of Medicine

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Clínico Universitario de Valencia

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

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.


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.

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.

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

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

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

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

location_facility: LLC Family Outpatient Clinic № /ID# 214455

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

location_facility: Matsuyama Red Cross Hospital /ID# 216021

location_facility: Immanuel Kant Baltic Federal University /ID# 218259

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

location_facility: Kazan State Medical University /ID# 214421

location_facility: Hacettepe Universitesi Tip Fak /ID# 214898

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

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

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

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

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

location_facility: Chelyabinsk Regional Clinical Hospital /ID# 214463

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 214458

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

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

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

location_facility: Biopharma Informatic - Park Row /ID# 215907

location_facility: Hospital Universitario La Paz /ID# 216032

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

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

location_facility: Multifield Medical Centre of ONMU /ID# 214149

location_facility: Peking Union Medical College Hospital /ID# 216545

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

location_facility: Tel Aviv Sourasky Medical Center /ID# 216956

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 215187

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

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

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

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

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

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

location_facility: Hevizgyogyfurdo es Szent Andras Reumakorhaz /ID# 215184

location_facility: Gachon University Gil Medical Center /ID# 214534

location_facility: Universitair Ziekenhuis Leuven /ID# 215006

location_facility: Kaohsiung Veterans General Hos /ID# 214332

location_facility: Barwon Rheumatology Services /ID# 215508

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

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

location_facility: Kyunghee University Hospital at Gangdong /ID# 214296

location_facility: Orenburg State Medical University /ID# 214408

location_facility: Ternopil University Hospital /ID# 214705

location_facility: Wayne State University Health Center /ID# 215930

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

location_facility: Sweet Hope Research Specialty Inc /ID# 215931

location_facility: Chung Shan Medical University Hospital /ID# 214018

location_facility: Hokkaido University Hospital /ID# 215221

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

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

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

location_facility: West Texas Clinical Research /ID# 215928

location_facility: Far Eastern Memorial Hospital /ID# 215384

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

location_facility: Rheumatologische Schwerpunktpraxis Brandt-Juergens /ID# 214282

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

location_facility: Rheumatology and Pulmonary Clinic /ID# 214946

location_facility: Juntendo University Hospital /ID# 214929

location_facility: Percuro Clinical Research, Ltd /ID# 215302

location_facility: Centro de Investigaciones Medicas Tucuman /ID# 214559

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

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

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

location_facility: Diagnostic consultative center 17 Sofia /ID# 214808

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

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

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

location_facility: Universitaetsklinikum Erlangen /ID# 214281

location_facility: Nagasaki University Hospital /ID# 215947

location_facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 215183

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

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

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

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

location_facility: Seoul National University Hospital /ID# 214532

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

location_facility: China Medical University Hospital /ID# 214019

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

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

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

location_facility: Huashan Hospital, Fudan University /ID# 216646

location_facility: Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 214212

location_facility: Hanyang University Seoul Hospital /ID# 214297

location_facility: The Chaim Sheba Medical Center /ID# 215854

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

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

location_facility: Nasz Lekarz Przychodnie Medyczne /ID# 214352

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

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

location_facility: Hospital Universitario Reina Sofia /ID# 214968

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

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

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

location_facility: Japanese Red Cross Okayama Hospital /ID# 214732

location_facility: Greater Chicago Specialty Physicians /ID# 216213

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

location_facility: CenterPointe Institute of Research /ID# 215793

location_facility: Newport Huntington Medical Group /ID# 216281

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 214784

location_facility: Oregon Health and Science University /ID# 216446

location_facility: NYU Langone Orthopedic Center /ID# 215594

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

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

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

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

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

location_facility: Omsk Regional Clinic Hospital /ID# 214464

location_facility: Medical Center CONSILIUM MEDICAL /ID# 216234

location_facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 215181

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 214501

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

location_facility: ETYKA-Osrodek Badan Klinicznych /ID# 215572

location_facility: Khmelnytskyi Regional Hospital /ID# 214153

location_facility: Revmatologicky ustav v Praze /ID# 215154

location_facility: Clinical Pharmacology Study Group /ID# 215293

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 214965

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

location_facility: Okinawa Prefectural Chubu Hospital /ID# 215575

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

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

location_facility: Narodny ustav reumatickych chorob /ID# 214674

location_facility: Medizinische Hochschule Hannover /ID# 214209

location_facility: Alliance Biomedical Ural Group /ID# 214457

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 214488

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

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 215306

location_facility: Innovation Medical Research Center /ID# 216068


acronym: INDIGO

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

lead_sponsor: Institut de Recherches Internationales Servier

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

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University of California Irvine - Hospital

location_facility: University of Pittsburgh Hillman Cancer Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Lille

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

location_facility: University of Texas Southwestern Medical Center

location_facility: The University of Utah, Huntsman Cancer Hospital

location_facility: Western General Hospital Edinburgh - PPDS

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

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

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.


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

lead_sponsor: Bioverativ, a Sanofi company

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

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

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 (QoL) 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 FVIII activity assays

status_simplified: Completed


title: A Randomized, Open-label, Two Arm, Parallel Group, Proof-of-concept Clinical Trial to Investigate the Efficacy and Safety of LNP023 Compared With Rituximab in the Treatment of Subjects With Idiopathic Membranous Nephropathy

summary: This is a randomized, open-label, two arm, parallel group, proof-of-concept, non-confirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with membranous nephropathy (MN) who are at high risk of disease progression defined on the basis of antibody anti-PLA2R titre and proteinuria.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Spain
United Kingdom
Netherlands
Argentina
France
United States
China
India
Singapore
Germany
Czechia


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


title: Open Label Dose-escalation and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence and Clinical Activity of UCART22 (Allogeneic Engineered T-cells Expressing Anti-CD22 Chimeric Antigen Receptor) in Patients With Relapsed or refractoryCD22+ B-cell Acute Lymphoblastic Leukemia (B-ALL)

summary: This is a first-in-human, open-label, dose escalation and expansion study of UCART22 administered intravenously to patients with relapsed or refractory B-cell acute Lymphoblastic Leukemia (B-ALL). The purpose of this study is to evaluate the safety and clinical activity of UCART22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)

lead_sponsor: Cellectis S.A.

location_country:
United States
France

location_facility: Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie

location_facility: Weill Medical College of Cornell University

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Hôpital Robert Debré - Service d'hémato-immunologie

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center


acronym: CAPELLA

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

lead_sponsor: Gilead Sciences

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.

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

location_facility: Instituto Dominicano de Estudios Virologicos (IDEV)

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

location_facility: Hospital Dr. Salvador Bienvenido Gautier

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

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: AIDS Healthcare Foundation - South Beach

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Faculty of Medicine, Khon Kaen University

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: Bamrasnaradura Infectious Diseases Institute

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

location_facility: Maple Leaf Research/Maple Leaf Medical Clinic

location_facility: Faculty of Medicine Siriraj Hospital, Mahidol University

location_facility: Universitätsklinikum Frankfurt, Medizinische Klinik II

location_facility: Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie

location_facility: Clinique de médecine urbaine du Quartier Latin

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: North Shore University Hospital/Division of Infectious Diseases

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

location_facility: Hospital Universitari Germans Trías i Pujol

location_facility: Durban International Clinical Research Site, Enhancing Care Foundation

location_facility: Atrium Health- Infectious Disease Consultants

location_facility: National Hospital Organization Nagoya Medical Center

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

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

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

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Taoyuan General Hospital, Ministry of Health and Welfare

location_facility: Midland Florida Clinical Research Center, LLC

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).


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: García-Martínez 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.

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

location_facility: START South Texas Accelerated Research Therapeutics, LLC

location_facility: The University of Texas MD Anderson Cancer Center


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:
Portugal
Spain
Italy
Austria
France
United States
Belgium
Germany
Czechia

location_facility:
MorphoSys Research Site
Medizinische Universtät Innsbruck


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


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)

summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Germany

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Universitaria Maggiore della Carità Novara

location_facility: szabolcs-szatmár-bereg megyei kórházak és egyetemi oktatókórház Jósa András Oktatókórház

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire (CHU) de Nice

location_facility: AORMN Hospital Hematology and BMT Center

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

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologi

location_facility: Hospital Universitario Virgen de la Victoria de Málaga

location_facility: Oxford University Hospitals NHS Trust, Churchill Hospital


title: A Multi-Center Randomised Open-Label Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

acronym: RELEASE

summary: This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable.

lead_sponsor: PCI Biotech AS

location_country:
Denmark
Poland
Taiwan
Spain
Italy
Finland
Ukraine
Sweden
Korea, Republic of
United States
France
Belgium
Norway
Germany

location_facility: Emory University Hospital, 1365C Clifton Road NE

location_facility: Universitätsklinikum Hamburg Eppendorf, I. Medizinische Klinik und Poliklinik (Gastroenterologie mit Sektionen Infektiologie und Tropenmediz)

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Klinikum der Ludwig-Maximilians-Universität MünchenKlinik

location_facility: National Cancer Center, 323 Ilsan-ro, Ilsandong-gu

location_facility: Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu

location_facility: Chang Gung Memorial Hospital, Linkou, Dept. of Medical Oncology, 5 Fuxing Street, Guishan

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Institut Gustave Roussy, Département de gastro-entérologie

location_facility: Klinikum Nürnberg Nord, Medizinische Klinik 6 - (Schwerpunkte Gastroenterologie, Hepatologie, Endokrinologie)

location_facility: Tampereen yliopistollinen sairaala, Syöpätautien klinikka

location_facility: University of Chicago Medical Center, 5841 South Maryland Avenue

location_facility: SI Institute for General and Urgent Surgery n.a. V.T. Zaitseva of NAMS of Uktraine

location_facility: Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

location_facility: Kyungpook National University Chilgok Hospital, 807 Hoguk-ro, Buk-gu

location_facility: The Mayo Clinic Hospital - Saint Mary's Campus, 1216 Second Street Southwest

location_facility: Pusan National University Hospital, 179 Gudeok-ro, Seo-gu

location_facility: Karolinska Universitetssjukhuset Solna, P.O Bäckencancer, Karolinska Universitetssjukhuset

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Municipal Nonprofit Enterprise City Hospital #3 of Zaporizhzhia City Council

location_facility: CHU Dupuytren, 2 Avenue Martin Luther King

location_facility: MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital, 222 Banpo-Daero Seocho-gu

location_facility: Taichung Veterans General Hospital, No. 1650 Taiwan Boulevard, Sec. 4

location_facility: Severance Hospital Yonsei University Health System, 50-1, Yonsei-Ro, Seodaemun-Gu

location_facility: SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine

location_facility: Taipei Veterans General Hospital, No. 201, Sction 2, Shi-pai Road

location_facility: Oslo Universitetssykehus HF Radiumhospitalet

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico


title: Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B With Inhibitors

summary: This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. The group will be decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with study medicine every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about three years. Participants will have to come to the clinic for up to 33 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months depending on the group participants are in and approximately 8 weeks for the rest of the study. At all visits, blood samples will be taken. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
India
Turkey
Mexico
Norway
Malaysia
Sweden
Slovakia
Bulgaria
Denmark
Thailand
Algeria
France
Korea, Republic of


title: Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

summary: This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

lead_sponsor: Applied Therapeutics, Inc.

location_country:
Poland
Hong Kong
Spain
United Kingdom
Australia
Canada
United States
France
Germany
Czechia

location_facility: LMC Diabetes & Endocrinology Ltd. - Brampton

location_facility: Barts and The London School of Medicine & Dentistry

location_facility: Juno Research, LLC - Southwest Houston Site

location_facility: University of California, San Diego (UCSD)

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK

location_facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

location_facility: CHU de Nantes, Clinique d'Endocrinologie

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Barwon Health-University Hospital Geelong

location_facility: Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum

location_facility: Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice

location_facility: Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics

location_facility: LMC Diabetes & Endocrinology Ltd. - Toronto

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu

location_facility: LMC Diabetes & Endocrinology Ltd. - Etobicoke

location_facility: Hospital Abente y Lago (Complejo Universitario de la Coruña)

location_facility: Westside Medical Associates of Los Angeles

location_facility: Prywatny Gabinet Lekarski Centrum Medyczne Diabetika

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Hospital Clinico Universitario de Valencia

location_facility: ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH

location_facility: University of California - Irvine Medical Center

location_facility: Topolowa MEDICENTER Mrózek & wspólnicy sp.j.

location_facility: Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition

location_facility: LMC Diabetes & Endocrinology Ltd. - Thornhill

location_facility: Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University

location_facility: NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny


title: An Open-Label, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of RO7227166 (a CD19 Targeted 4-1BB Ligand) in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

summary: This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of RO7227166 in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). RO7227166 will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered seven days prior to the first administration of RO7227166 and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
United States
France
Belgium

location_facility: CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte

location_facility: University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Washington University School of Medicine

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT


title: A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)

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:
Spain
Italy
United Kingdom
United States
Belgium
Philippines
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Argentina
Turkey
Slovakia
Canada
Guatemala
Hungary
Germany
Denmark
Greece
Thailand
Korea, Republic of
France
Colombia
Netherlands

summary: This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.


title: Abbott DBS Post-Market Study of Outcomes for Indications Over Time

acronym: ADROIT

summary: The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Abbott Medical Devices

location_country:
Taiwan
Spain
Italy
United Kingdom
Australia
Finland
United States
France
Germany

location_facility: University of South Florida - Department of Neurology

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: Thomas Jefferson Department or Neurosurgery

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Medizinische Einrichtungen der Universität Düsseldorf

location_facility: Allegheny General Hospital Department of Neurosurgery

location_facility: Wright State University & Premier Health

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: UKE Hamburg (Universitatsklinik Eppendorf)

intervention_type: Device


title: Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

lead_sponsor: Incyte Corporation

ReferenceCitation: Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828.

location_country:
Poland
Spain
Italy
Canada
United States
France
Germany
Bulgaria

location_facility: University Clinic Carl Gustav Carus, Technical University Dresden

location_facility: International Clinical Research Tennessee Llc

location_facility: Synexus - Polska Sp Z Oo Oddzial W Gdansk

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Gdyni

location_facility: Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume

location_facility: Forcare Clinical Research Fcr Forward Clinical Trials, Inc

location_facility: University of California San Francisco Sub Location

location_facility: Dermatology Associates of Plymouth Meeting

location_facility: Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Poznaniu

location_facility: McGill University Health Centre / Carey/Wang Clinic

location_facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

location_facility: Cognitive Clinical Trials Scottsdale Btc Ppds

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Multiprofile Hospital For Active Treatement - Clinic of Dermatology and Venerology

summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).