title: A Phase 2, Randomized, Open-Label, Multicenter Study to Evaluate Safety and Efficacy of Single Agent Selinexor Versus Treatment of Physician's Choice in Patients With Previously Treated Myelofibrosis

summary: This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians' choice of treatment.

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Italy
Poland
United States
China
Spain
Greece
France

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Asst Settelaghi, Ospedale Di Circolo E Fondazione Macchi

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: Centre Hospitalier Universitaire d'Angers (CHU Angers)

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

location_facility: Affiliated Hospital of Nantong University

location_facility: Suzhou University -The First Affiliated Hospital

location_facility: University of Perugia Department of Medicine Hematology Section

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

location_facility: Università degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - Dipartimento di medicina sperimentale e clinica

location_facility: Azienda Unita Sanitaria Locale Latina - Ospedale Santa Maria Goretti

location_facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre d'Investigations Cliniques (CIC)


title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

summary: prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United Kingdom
Netherlands
United States
Spain
Czechia
Canada
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: St. Elizabeth Medical Center - South Unit

location_facility: Kansas City Cardiac Arrhythmia Research Foundation

location_facility: New York Presbyterian Hospital/Cornell University

location_facility: Institut de Cardiologie de Quebec (Hospital Laval)

location_facility: University Hospital - University of Alabama at Birmingham (UAB)

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: APPLY-PNH

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

summary:
This study was a multi-center, randomized, open-label, active comparator-controlled, parallel group study.

The purpose of this Phase 3 study in PNH patients presenting with residual anemia despite treatment with anti-C5 antibody, was to determine whether iptacopan is efficacious and safe for the treatment of PNH through demonstration of superiority of iptacopan compared to anti-C5 antibody treatment.

status: Completed

title: A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody.

type: EudraCT Number

source: euctr

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.

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
United Kingdom
Japan
Brazil
Netherlands
United States
Korea, Republic of
Spain
Taiwan
Czechia
France

ipd_sharing: Yes

status_simplified: Completed


acronym: PRidopidine Outcome on Function in Huntington Disease (PROOF-HD)

lead_sponsor: Prilenia

summary: This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).

location_facility: Prilenia Investigational Site (Site 380)

location_facility: Prilenia Investigational Site (Site 019)

location_facility: Prilenia Investigational Site (Site 088)

location_facility: Prilenia Investigational Site (Site 044)

location_facility: Prilenia Investigational Site (Site 387)

location_facility: Prilenia Investigational Site (Site 381)

location_facility: Prilenia Investigational Site (Site 384)

location_facility: Prilenia Investigational Site (Site 119)

location_facility: Prilenia Investigational Site (Site 018)

location_facility: Prilenia Investigational Site (Site 098)

location_facility: Prilenia Investigational Site (Site 390)

location_facility: Prilenia Investigational Site (Site 076)

location_facility: Prilenia Investigational Site (Site 031)

location_facility: Prilenia Investigational Site (Site 343)

location_facility: Prilenia Investigational Site (Site 382)

location_facility: Prilenia Investigational Site (Site 017)

location_facility: Prilenia Investigational Site (Site 249)

location_facility: Prilenia Investigational Site (Site 394)

location_facility: Prilenia Investigational Site (Site 377)

location_facility: Prilenia Investigational Site (Site 028)

location_facility: Prilenia Investigational Site (Site 385)

location_facility: Prilenia Investigational Site (Site 326)

location_facility: Prilenia Investigational Site (Site 087)

location_facility: Prilenia Investigational Site (Site 392)

location_facility: Prilenia Investigational Site (Site 006)

location_facility: Prilenia Investigational Site (Site 020)

location_facility: Prilenia Investigational Site (Site 244)

location_facility: Prilenia Investigational Site (Site 089)

location_facility: Prilenia Investigational Site (Site 246)

location_facility: Prilenia Investigational Site (Site 048)

location_facility: Prilenia Investigational Site (Site 032)

location_facility: Prilenia Investigational Site (Site 232)

location_facility: Prilenia Investigational Site (Site 176)

location_facility: Prilenia Investigational Site (Site 379)

location_facility: Prilenia Investigational Site (Site 027)

location_facility: Prilenia Investigational Site (Site 096)

location_facility: Prilenia Investigational Site (Site 239)

location_facility: Prilenia Investigational Site (Site 051)

location_facility: Prilenia Investigational Site (Site 002)

location_facility: Prilenia Investigational site (Site 292)

location_facility: Prilenia Investigational Site (Site 061)

location_facility: Prilenia Investigational Site (Site 180)

location_facility: Prilenia Investigational Site (Site 333)

location_facility: Prilenia Investigational Site (Site 393)

location_facility: Prilenia Investigational Site (Site 378)

location_facility: Prilenia Investigational Site (Site 029)

location_facility: Prilenia Investigational Site (Site 376)

location_facility: Prilenia Investigational Site (Site 083)

location_facility: Prilenia Investigational Site (Site 037)

location_facility: Prilenia Investigational Site (Site 199)

location_facility: Prilenia Investigational Site (Site 030)

location_facility: Prilenia Investigational Site (Site 160)

location_facility: Prilenia Investigational Site (Site 228)

location_facility: Prilenia Investigational site (Site 291)

location_facility: Prilenia Investigational Site (Site 388)

location_facility: Prilenia Investigational Site (Site 175)

location_facility: Prilenia Investigational Site (Site 234)

location_facility: Prilenia Investigational Site (Site 386)

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Arm, Multicenter Study Evaluating the Efficacy and Safety of Pridopidine in Patients With Early Stage of Huntington Disease

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Austria
United States
Spain
Czechia
Canada
France


intervention_type: Biological

lead_sponsor: Atara Biotherapeutics

summary: The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with Epstein-Barr virus (EBV) associated diseases.

location_facility: Children's Hospital of Orange County (Pediatrics [up to 25 years old])

location_facility: Oregon Health and Science University (Adults and Pediatrics)

location_facility: Uniklinikum Salzburg Landeskrankenhaus (Adults only)

location_facility: Great Ormond Street Hospital (Pediatrics only)

location_facility: Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])

location_facility: Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)

location_facility: Medizinische Universität Wien (Adults only)

location_facility: Hôpital Universitaire Pitié Salpêtrière (Adults only)

location_facility: Hôpital Saint-Eloi (Adults and Pediatrics)

location_facility: Columbia University Irving Medical Center (Adults only)

location_facility: Medical University of South Carolina (Adults and Pediatrics)

location_facility: Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics)

location_facility: Hospital Universitario Ramón y Cajal (Adults only)

location_facility: Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke (Adults only)

location_facility: Ospedale Pediatrico Bambino Gesù (Adults and Pediatrics)

location_facility: Sylvester Comprehensive Cancer Center/ University of Miami

location_facility: University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)

location_facility: University of California Los Angeles (UCLA) (Adults and Pediatrics)

location_facility: Hospital Universitari Vall d'Hebrón (Adults and Pediatrics)

location_facility: University of Michigan Rogel Cancer Center (Adults and Pediatrics)

location_facility: Lucile Packard Children's Hospital Stanford (Pediatrics only)

location_facility: University of Maryland Medical Center (Adults only)

location_facility: Emory University/Winship Cancer Institute (Adults [>= 16 years])

location_facility: Medizinische Universität Graz (Adults only)

location_facility: University Hospital Birmingham NHS Foundation Trust (Adults only)

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan (Adults only)

location_facility: Azienda Ospedaliero-Universitaria Pisana (Adults only)

location_facility: Washington University in St. Louis (Adults only)

location_facility: Hôpital Necker-Enfants Malades (Adults and Pediatrics)

location_facility: The Children's Hospital at Montefiore (Adults and Pediatrics)

location_facility: University of Texas Southwestern Medical Center (Pediatrics only)

location_facility: The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only)

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)

location_facility: Ospedale Infantile Regina Margherita (Pediatrics only)

location_facility: Hospital Universitario Viegen del Rocio (Adults and Pediatrics)

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (Pediatrics only)

status: Recruiting

title: An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases (EBVision)

enrollment_type: Anticipated

design_allocation: Non-Randomized

location_country:
Italy
United Kingdom
Austria
Belgium
United States
Spain
France


title: Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast

acronym: ROSALINE

summary: Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. A large majority of ILBC are ER+/HER2- and almost 90% have loss of E-cadherin (CDH1) expression. A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. Endocrine therapy being the mainstay of therapy for ER+/HER2- ILBC and the pre-operative setting offering a platform for rapid drug evaluation and biomarker research, the ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). The neoadjuvant therapy will last 4 months and post-operative therapy will follow local practice. Biomarker research will include RNA sequencing of initial biopsies and surgical specimens, as well as liquid biopsies.

ReferenceType: derived

ReferenceCitation: Agostinetto E, Nader-Marta G, Paesmans M, Ameye L, Veys I, Buisseret L, Neven P, Taylor D, Fontaine C, Duhoux FP, Canon JL, Denys H, Coussy F, Chakiba C, Ribeiro JM, Piccart M, Desmedt C, Ignatiadis M, Aftimos P. ROSALINE: a phase II, neoadjuvant study targeting ROS1 in combination with endocrine therapy in invasive lobular carcinoma of the breast. Future Oncol. 2022 Jul;18(22):2383-2392. doi: 10.2217/fon-2022-0358. Epub 2022 Jun 13.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Future Science Ltd

ReferenceCitation: Okines A, Irfan T, Asare B, Mohammed K, Osin P, Nerurkar A, Smith IE, Parton M, Ring A, Johnston S, Turner NC. Clinical outcomes in patients with triple negative or HER2 positive lobular breast cancer: a single institution experience. Breast Cancer Res Treat. 2022 Apr;192(3):563-571. doi: 10.1007/s10549-021-06432-z. Epub 2022 Feb 4.

publisher_dissemination: Springer-Nature

ipd_sharing: Undecided

lead_sponsor: Jules Bordet Institute

sponsor_collaborators:
Jules Bordet Institute
Hoffmann-La Roche

location_country: Belgium France

location_facility:
UZ Gent
Institut Jules Bordet
Institut Bergonié
Grand Hôpital de Charleroi
UZ Leuven
UCL Saint-Luc
Institut Curie
CHU Namur - Sainte Elisabeth
Institut Gustave Roussy
UZ Brussel


title: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

acronym: MINT

summary: Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

lead_sponsor: Viela Bio (acquired by Horizon Therapeutics)

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Canada
France
Belarus
Denmark
United States
Ukraine
India
China
Italy
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility:
Viela Bio Investigative Site - 4203
Viela Bio Investigative Site - 1020
Viela Bio Investigative Site - 3310
Viela Bio Investigative Site - 4404
Viela Bio Investigative Site - 3902
Viela Bio Investigative Site - 1005
Viela Bio Investigative Site 4003
VielaBio Investigative Site - 2206
Viela Bio Investigative site 4010
Viela Bio Investigative Site - 3204
Viela Bio Investigative Site - 3003
VielaBio Investigative Site - 4407
Viela Bio Investigative Site - 3404
Viela Bio Investigative Site - 3905
Viela Bio Investigative Site - 1013
Viela Bio Investigative Site - 5311
Viela Bio Investigative Site - 3001
Viela Bio investigative Site - 4605
Viela Bio Investigative Site - 1009
Viela Bio Investigative Site - 1007
Viela Bio Investigative Site - 5301
VielaBio Investigative Site - 2203
Viela Bio Investigative Site - 3302
Viela Bio Investigative Site - 4606
VielaBio Investigative Site - 2002
Viela Bio Investigative Site - 1001
Viela Bio Investigative Site - 5601
Viela Bio Investigative Site - 4101
Viela Bio Investigative Site - 1011
Viela Bio Investigative Site - 5308
Viela Bio Investigative Site - 3402
Viela Bio Investigative Site -4607
Viela Bio Investigative Site - 4004
Viela Bio Investigative Site - 3901
Viela Bio Investigative Site - 4113
Viela Bio Investigative Site - 1008
Viela Bio Investigative Site - 5702
Viela Bio Investigative Site - 2205
VielaBio Investigative Site - 3101
Viela Bio Investigative Site - 4201
Viela Bio Investigative Site - 4102
Viela Bio investigative Site - 4105
Viela Bio Investigative Site - 5701
Viela Bio Investigative Site - 5306
Viela Bio Investigative Site - 4602
Viela Bio Investigative Site - 4604
Viela Bio Investigative Site - 3203
Viela Bio Investigative Site - 5602
Viela Bio Investigative Site - 4109
Viela Bio Investigative Site - 4410
Viela Bio Investigative Center - 1024
Viela Bio Investigative Site - 5304
Viela Bio Investigative Site - 1003
Viela Bio Investigative Site - 1004
Viela Bio Investigative Site - 4008
Viela Bio Investigative Site - 2003
Viela Bio Investigative Site - 1015
Viela Bio Investigative Site - 4110
Viela Bio Investigative Site - 1102
Viela Bio Investigative Site - 5201
Viela Bio Investigative Site - 1010
Viela Bio Investigative Site - 1017
Viela Bio Investigative Site - 4011
Viela Bio Investigative Site 4608
Viela Bio Investigative Site - 1016
Viela Bio Investigative Site - 1012
Viela Bio Investigative Site - 1002
Viela Bio Investigative Site 4405
Viela Bio Investigative Site - 1014
Viela Bio Investigative Site - 3401
Viela Bio Investigative Site - 3002
Viela Bio Investigative Site - 5312
Viela Bio Investigative Site - 1101
Viela Bio Investigative Site - 5103
Viela Bio Investigative Site - 4006
Viela Bio Investigative Site - 4401
Viela Bio Investigative Site - 4007
Viela Bio Investigative Site - 4112
Viela Bio Investigative Site - 1018
Viela Bio Investigative Site - 1025
Viela Bio Investigative Site - 5202
Viela Bio Investigative Site - 1104
Viela Bio Investigative Site - 4202
Viela Bio Investigative Site - 3303
Viela Bio Investigative Site - 5305
Viela Bio Investigative Site - 5203
Viela Bio Investigative Site - 5106
Viela Bio Investigative Site - 3903
Viela Bio Investigative Site - 5204
Viela Bio Investigative Site - 5104
Viela Bio Investigative Site - 5105
Viela Bio Investigative Site - 4111
Viela Bio Investigative Site - 4108
Viela Bio Investigative Site - 4103
Viela Bio Investigative Site - 5101
VielaBio Investigative Site - 2201
Viela Bio Investigative Site - 4104
Viela Bio Investigative Site - 5302
Viela Bio Investigative Site - 1019
Viela Bio Investigative Site - 3305
Viela Bio Investigative Site - 3201
Viela Bio Investigative Site - 3202
Viela Bio Investigative Site 4009
VielaBio Investigative Site - 2207
Viela Bio Investigative Site 4012
Viela Bio Investigative Site 4409
Viela Bio Investigative Site - 4601
Viela Bio Investigative Site - 4005
Viela Bio Investigative Site - 4402
Viela Bio Investigative Site - 4603
Viela Bio Investigative Site - 5703
VielaBio Investigative Site - 4408
Viela Bio Investigative Site - 4406
Viela Bio Investigative Site - 1006
Viela Bio Investigative Site - 2001
Viela Bio Investigative Site - 5303
Viela Bio Investigative Site - 3306
Viela Bio Investigative Site - 3301
VielaBio Investigative Site - 4411
Viela Bio Investigative Site - 5309
Viela Bio Investigative Site - 3403
Viela Bio Investigative Site - 1103
Viela Bio Investigative Site - 4413


title: A Phase II Trial of Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Stage II-III Rectal Cancer

acronym: REGINA

summary:
This is a multicenter, single-arm, phase II study of nivolumab in combination with regorafenib in subjects with locally-advanced rectal cancer who are eligible for a curative treatment including pre-operative SCRT and TME(or watch & wait approach). The study is based on the Simon's two-stage design and a maximum of 60 subjects will be enrolled. In addition to the standard efficacy interim analysis according to the statistical design, a safety interim analysis will be performed on the first 6 subjects who have completed the study treatment to ensure safe continuation of the study investigation.

Eligible subjects will be treated according to the following sequential treatment plan:

Induction treatment: This consists of treatment with nivolumab (240 mg intravenously, on day 1 and 15) and regorafenib (80 mg/day orally, from day 1 to 14)
Standard SCRT: This consists of 25 Gy delivered in 5 fractions (from day 22 to 26)
Consolidation treatment: This consists of treatment with nivolumab (240 mg intravenously, on day 29, 43 and 57) and regorafenib (80 mg/day orally, from day 29 to 49)
Surgery: Surgical resection will be performed according to the principles of TME (between day 74 and 87, i.e., between 7 to 8 weeks after completion of SCRT). As an alternative to surgery, subjects who achieve cCR can be offered a watch & wait approach.
Adjuvant chemotherapy: Administration of adjuvant chemotherapy will be left to the discretion of the treating physician

The study also includes translational procedures (i.e. collection of tumour biopsies, blood samples and stool samples at pre-specified time points) for exploratory molecular and immune contexture analyses. These are mandatory for all study subjects.

location_facility: Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

location_facility: Centre de Lutte Contre le Cancer Georges Francois Leclerc

location_facility: Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia

summary: This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy)

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Italy
Poland
Portugal
United Kingdom
Australia
Switzerland
Belgium
United States
Korea, Republic of
Czechia
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centro Ricerche Cliniche di Verona s.r.l.

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii


lead_sponsor: Boehringer Ingelheim

summary:
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin.

At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.

location_facility: Total Skin and Beauty Dermatology Center, PC

location_facility: Markusovszky University Teaching Hospital

location_facility: Shiga University of Medical Science Hospital

location_facility: The Psoriasis Treatment Center of Central New Jersey

location_facility: Seoul National University Bundang Hospital

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Tokyo Dental College Ichikawa General Hospital

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: SimcoDerm Medical and Surgical Dermatology Centre

location_facility: Dermatovenereological Dispensary #10, St. Petersburg

location_facility: The Guenther Dermatology Research Centre

status: Terminated

title: An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials

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.

location_country:
Germany
Poland
Hungary
United Kingdom
Australia
Japan
Belgium
United States
Korea, Republic of
Taiwan
Czechia
Canada
Russian Federation
France

status_simplified: Unknown


acronym: DOMINO

lead_sponsor: ViiV Healthcare

summary: This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial. It will aim to investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (abacavir/lamivudine [ABC/3TC] or emtricitabine/tenofovir alafenamide [FTC/TAF])

ReferenceCitation: Spinner CD, Felizarta F, Rizzardini G, Philibert P, Mitha E, Domingo P, Stephan CJ, DeGrosky M, Bainbridge V, Zhan J, Dumitrescu TP, Jeffrey JL, Xu J, Halliday F, Gan J, Johnson M, Gartland M, Joshi SR, Lataillade M. Phase IIa Proof-of-Concept Evaluation of the Antiviral Efficacy, Safety, Tolerability, and Pharmacokinetics of the Next-Generation Maturation Inhibitor GSK3640254. Clin Infect Dis. 2022 Sep 14;75(5):786-794. doi: 10.1093/cid/ciab1065.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

title: A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults

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

location_country:
Germany
Italy
Portugal
Argentina
Switzerland
United States
Spain
South Africa
Canada
Russian Federation
France


title: A Multi-Center, Open-Label, Phase 2 Study to Evaluate Safety and Efficacy of U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer (CRC)

summary: This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
Poland
United Kingdom
Japan
Belgium
United States
Spain
France

location_facility: M Sklodowska Curie Memorial Cancer Center

location_facility: Consorci Corporació Sanitària Parc Taulí de Sabadell

location_facility: Szpital Kliniczny Przemienienia Pańskiego.University Hospital, Chemotherapy Department

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: VHIO Valle de Hebron Instituto de Oncologia

location_facility: National Hospital Organization - Osaka National Hospital (ONH)

location_facility: Northwestern Medical Faculty Foundation NMFF Hematology Oncology

location_facility: MD Anderson Cancer Center University of Texas

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: John Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Hospital del Mar - Institut Hospital del Mar d'Investigacions Mediques IMIM

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitario HM Sanchinarro, CIOCC

location_facility: City of Hope Comprehensive Cancer Center


title: A Phase 1/2 Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders

acronym: LIMBER

summary: This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy or in combination with ruxolitinib in participants with MF who are transfusion-dependent or presenting with symptomatic anemia. This study will consist of 2 parts: dose escalation and expansion.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Italy
United Kingdom
Japan
United States
Canada
France

location_facility: S Orsolas University Hospital Seragnoli Institute of Hematology

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Emory University-Winship Cancer Institute

location_facility: Ospedale Santa Maria Della Misericordia Perugia

location_facility: Azienda Ospedaliero-Universitaria Careggi (Aouc)

location_facility: Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Jewish General Hospital / McGill University

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

location_facility: Royal Cornwall Hospital Truro Sunrise Centre

location_facility: Emory University - Winship Cancer Institute


type: Other Identifier

title: EXPLORE: A Phase II, Outcomes Assessor-masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

acronym: EXPLORE

summary: The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).

lead_sponsor: Gyroscope Therapeutics Limited

sponsor_collaborators:
Gyroscope Therapeutics Limited
Novartis Pharmaceuticals

location_country:
Germany
Poland
United Kingdom
Australia
Netherlands
United States
Spain
France

location_facility: Retinal Research Institute (retina consultants of AZ)

location_facility: Stichting Radboud Universitair Medisch Centrum

location_facility: Hospital Universitari General de Catalunya

location_facility: Moorfields Eye Hospital - NHS Foundation Trust

location_facility: Oftalmika Spolka z ograniczona odpowiedzialnoscia

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Vision Research Center Eye Associates of New Mexico

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Lübeck

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)

location_facility: Retina Associates of Southern California


acronym: COMMODORE 1

lead_sponsor: Hoffmann-La Roche

summary: A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_facility: Indiana Blood & Marrow Transplantation, LLC

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hrpc - Health Clinical Research Representation - Eireli

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

location_facility: Nucleo de Pesquisa Clinica do Hospital da Crianca

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Universitario Walter Cantidio - UFC

location_facility: Szpital Uniwersytecki nr2 im. dr J. Biziela

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Marmara University Pendik Training and Research Hospital, Hematology Department

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Japanese Red Cross Society Suwa Hospital

location_facility: Complejo Hospitalario Universitario de Santiago.

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Kobe University Hospital; Medical Oncology and Hematology

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Hospital Regional Universitario de Malaga

location_facility: Nationwide Children's Hospital; Dept. of Pulmonology

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hualien Tzu Chi Hospital; Hematology and oncology

location_facility: Istanbul University Istanbul Medical Faculty; Neurology

location_facility: Severance Hospital; Yonsei University Health System

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico

location_facility: CHU Rennes - Hopital Pontchaillou; Service d'Hémostase Bioclinique

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Institut Paoli Calmette; Service d'Hématologie Clinique

location_facility: Ege University Medical Faculty; Hematology

location_facility: MacKay Memorial Hospital; Hematology and oncology

location_facility: University General Hospital of Alexandroupolis

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

title: A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Safety, Pharmacokinetics, Pharmacodynamic And Efficacy of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

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:
Germany
Ireland
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Colombia
Portugal
Hungary
Hong Kong
United States
Belgium
Estonia
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Saudi Arabia
Spain
Greece
Taiwan
Sweden


acronym: PULSAR

lead_sponsor: Bayer

summary: In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.

sponsor_collaborators:
Bayer
Regeneron Pharmaceuticals

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Beijing Tongren Hospital, Capital Medical University (East)

location_facility: Tianjin Medical University General Hospital

location_facility: The People's Hospital of Ningxia Hui Autonomous Region

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Ophthalmic Consultants of the Capital Region

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: ALM Oftalmolaser - Oftalmologia Medica e Cirurgica

location_facility: Retina Consultants of Texas - The Woodlands

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office

location_facility: Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

location_facility: The First Affiliated Hospital of Xinjiang Medical University

location_facility: Tokyo Women's Medical University Hospital

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Retina Consultants of Southern California

location_facility: Instituto Oftalmológico Francisco Gomez Ulla

location_facility: Hospital de la Santa Creu i Sant Pau | Gynecology Department

location_facility: Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: OFTALMOS, Instituto Oftalmologico de Alta Complejidad

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Henan Provincial Ophthalmology Hospital (Henan Eye Institute

location_facility: Hospital General Universitario de Valencia

location_facility: Szent-Gyorgyi Albert Orvostudomanyi Egyetem

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Japanese Red Cross Wakayama Medical center

location_facility: Arizona Retina and Vitreous Consultants - Research

location_facility: Kansai Medical University Medical Center

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Retina Vitreous Associates of Florida - Saint Petersburg

location_facility: Multiprofile Hospital for Active Treatment Sveta Sofia

location_facility: IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia

location_facility: Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

location_facility: Scientific Research Institution of Ophthalmic Diseases

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Eye Center of the second Bethune Hospital, jinlin University

location_facility: Organizacion Medica de Investigacion (OMI)

location_facility: Private enterprise private production company " Acinus"

location_facility: Seoul National University Bundang Hospital

location_facility: Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s.

location_facility: Northern California Retina-Vitreous Associates

location_facility: Retinal Consultants of Texas - San Antonio

location_facility: FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov

location_facility: Spec. Hosp. for Active Treatment for Eye Diseases Zrenie

location_facility: The First Affiliated Hospital of NanChang University

location_facility: The 1st Affiliated Hospital Fujian Medical University

location_facility: Kaiser Permanente Riverside Medical Center

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: The Second Hospital of Anhui medical university

location_facility: Shanghai Tongji Hospital of Tongji University

location_facility: The 1st Affiliated Hospital of Zhejiang University

location_facility: The Affiliated Eye Hospital of Wenzhou Medical College

location_facility: Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech

location_facility: Medical corporation Eiwakai Dannoue Ophthalmology clinic

location_facility: Retina Consultants of Southern Colorado, PC

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Specialized Hospital For Active Treatment of Eye Diseases Zora

location_facility: Centre d'Ophtalmologie - Paradis-Monticelli

title: Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Argentina
Australia
Japan
Czechia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
China
Estonia
Italy
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


lead_sponsor: Eli Lilly and Company

summary: The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: First Moscow State Medical University I.M. Sechenov

location_facility: Deaconess Clinic - Gateway Health Center

location_facility: Colorado Springs Neurological Associates

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Limited Liability Company University Clinic of headaches

location_facility: University of Miami Don Suffer Clinical Research Building

location_facility: New England Institute for Clinical Research

location_facility: Saint-Petersburg State Pediatric Medical University

location_facility: Accel Research Sites - Maitland Clinical Research Unit

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Orange County Research Institute - Ontario

location_facility: Minneapolis Clinic of Neurology - Burnsville Office

location_facility: All India Institute of Medical Sciences (AIIMS) - Nagpur

location_facility: Chicago Headache Center and Research Institute

location_facility: Integrated Clinical Trial Services, Inc.

location_facility: Seattle Women's: Health, Research, Gynecology

location_facility: Josephson Wallack Munshower Neurology, PC

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

location_facility: New England Regional headache Center, Inc

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital

location_facility: Bhakti Vedanta Hospital and Research Institute

location_facility: Japanese Red Cross Kyoto Daiichi Hospital

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: PanAmerican Clinical Research - Guadalajara

location_facility: Rophe Adult and Pediatric Medicine/SKYCRNG

location_facility: Miller Children's & Women's Hospital Long Beach

location_facility: University of Kentucky Chandler Medical Center

location_facility: Centre Hospitalier Général de Mont de Marsan - Hôpital Layné

title: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Germany
Italy
India
United Kingdom
Japan
Netherlands
Mexico
Belgium
United States
Spain
Puerto Rico
Russian Federation
France


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

summary: To evaluate the efficacy and safety of pamrevlumab versus placebo in combination with systemic corticosteroids in participants with non-ambulatory Duchenne muscular dystrophy (age 12 years and older).

lead_sponsor: FibroGen

location_country:
Italy
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
China
Spain
Czechia
Canada
France

location_facility: Klinika dÄ>tské neurologie, Neuromuskulární centrum

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

location_facility: Fakultní Nemocnice Brno - Dětská Nemocnice

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Carolinas HealthCare System Neurosciences Institute-Neurology - Charlotte

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Spectrum Health Hospitals Helen DeVos Children's Hospital

location_facility: Hospital General Universitario de Alicante

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Children's Specialty Group - Medical Center Office

location_facility: West China Second University Hospital, Sichuan University

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

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico Eugenio Medea - Lombardia

location_facility: Children's Hospital of Chongqing Medical University

location_facility: University of California Los Angeles Medical Center


intervention_type: Other

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: This study evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab administered in adult participants with coronavirus disease 2019 (COVID-19) severe pneumonia, acute lung injury, or acute respiratory distress syndrome. Participants were randomly assigned to receive ravulizumab in addition to best supportive care (BSC) (2/3 of the participants) or BSC alone (1/3 of the participants). BSC consisted of medical treatment and/or medical interventions per routine hospital practice.

ReferenceType: background

ReferenceCitation: WHO. Clinical management of severe acute respiratory infection when novel coronavirus (2019-nCoV) infection is suspected. Interim guidance, 28 January 2020.

ReferenceType: result

ReferenceCitation: McEneny-King AC, Monteleone JPR, Kazani SD, Ortiz SR. Pharmacokinetic and Pharmacodynamic Evaluation of Ravulizumab in Adults with Severe Coronavirus Disease 2019. Infect Dis Ther. 2021 Jun;10(2):1045-1054. doi: 10.1007/s40121-021-00425-7. Epub 2021 Apr 7.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: gold

ReferenceCitation: Smith K, Pace A, Ortiz S, Kazani S, Rottinghaus S. A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jul 13;21(1):639. doi: 10.1186/s13063-020-04548-z.

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

oa_host_type: repository

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

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk;pure.eur.nl

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Java A, Apicelli AJ, Liszewski MK, Coler-Reilly A, Atkinson JP, Kim AH, Kulkarni HS. The complement system in COVID-19: friend and foe? JCI Insight. 2020 Aug 6;5(15):e140711. doi: 10.1172/jci.insight.140711.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repositories_concat: PubMed Central;digitalcommons.wustl.edu

publisher_dissemination: American Society for Clinical Investigation

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Medical Hospital, Tokyo Medical and Dental University

title: A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared With Best Supportive Care in Patients With COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

location_country:
United Kingdom
Japan
United States
Spain
France


acronym: Coronavirus

lead_sponsor: Karyopharm Therapeutics Inc

summary: The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world.

location_facility: Levine Cancer Institute-Atrium Health University City

location_facility: Miami Cancer Institute at Baptist Health

location_facility: Servicio de Medicina Interna, Hospital Universitario de Salamanca, Universidad de Salamanca

location_facility: Hospital Hietzing, 2. Medical department - Center for Diagnosis and Therapy of Rheumatic Diseases

location_facility: MultiCare Institute for Research & Innovation (Puget Sound)

title: A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection

location_country:
France
United Kingdom
Austria
United States
Spain
Israel


title: An Exploratory Phase 1b Open-label Multi-arm Trial to Evaluate the Safety and Efficacy of CC-90009 in Combination With Anti-Leukemia Agents in Subjects With Acute Myeloid Leukemia

summary: CC-90009-AML-002 is an exploratory Phase 1b, open-label, multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in participants with acute myeloid leukemia (AML).

ReferenceCitation: Surka C, Jin L, Mbong N, Lu CC, Jang IS, Rychak E, Mendy D, Clayton T, Tindall E, Hsu C, Fontanillo C, Tran E, Contreras A, Ng SWK, Matyskiela M, Wang K, Chamberlain P, Cathers B, Carmichael J, Hansen J, Wang JCY, Minden MD, Fan J, Pierce DW, Pourdehnad M, Rolfe M, Lopez-Girona A, Dick JE, Lu G. CC-90009, a novel cereblon E3 ligase modulator, targets acute myeloid leukemia blasts and leukemia stem cells. Blood. 2021 Feb 4;137(5):661-677. doi: 10.1182/blood.2020008676.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

sponsor_collaborators: Celgene AbbVie

location_country:
United States
United Kingdom
Canada
France

location_facility:
Local Institution - 102
Local Institution - 402
Local Institution - 301
Local Institution - 105
Local Institution - 401
Local Institution - 101
Local Institution - 104
Local Institution - 404
Local Institution - 108
Local Institution - 103
Local Institution - 202
Local Institution - 107
Local Institution - 201


title: Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

summary: Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

lead_sponsor: Ancora Heart, Inc.

location_country:
Belarus
Netherlands
Belgium
United States
Czechia
France

location_facility: Tennova Healthcare-Turkey Creek Medical Center

location_facility: Republican Scientific and Practical Centre of Cardiology

location_facility: Cardiovascular Research Institute of Kansas

location_facility: Pinnacle Health Cardiovascular Institute

location_facility: Baylor College of Medicine St. Luke's Medical Center

location_facility: Texas Tech University Health Sciences Center

location_facility: Metropolitan Heart and Vascular Institute & Mercy Hosp

location_facility: Northern Light Eastern Maine Medical Center

location_facility: Our Lady of the Lake Regional Medical Center

location_facility: Methodist Healthcare System, San Antonio

location_facility: Baptist Health Heart Failure & Transplant Institute

location_facility: Weill Cornell Medicine-New York Presbyterian Hospital


lead_sponsor: Gilead Sciences

summary: The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy, and how safe it is in participants with metastatic cancer (cancer that has spread).

ReferenceCitation: Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.

publisher_dissemination: Wolters Kluwer Health

location_facility: Florida Cancer Specialists & Research Institute

location_facility: University of MD Greenebaum Comprehensive Cancer Center

location_facility: Christiana Care Health Services, Christiana Hospital

location_facility: New York Cancer & Blood Specialists - Setauket Medical Oncology

location_facility: The University of Texas M.D. Anderson Cancer Center

status: Enrolling by invitation

title: Open-label Rollover Study to Evaluate Long-Term Safety in Subjects With Metastatic Solid Tumors That Are Benefiting From Continuation of Therapy With Sacituzumab Govitecan

location_country:
United States
Belgium
France


title: A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

summary: This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.

lead_sponsor: Sol-Gel Technologies, Ltd.

location_country:
Germany
Italy
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
France

location_facility: Columbia University Irving Medical Center

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Utah, Midvalley Dermatology


title: Screening/Observational Protocol to Determine Patient Eligibility for Inclusion in AAV Gene Therapy Clinical Trials (ECLIPSE)

acronym: ECLIPSE

summary: Freeline is developing adeno-associated virus (AAV) vector based gene therapies for a number of diseases and is actively advancing a programme in Haemophilia B (HB). This study aims to collect prospective data to characterise bleeding events and Factor IX (FIX) concentrate consumption in HB patients that can be used as baseline for participants who elect to participate in a subsequent Freeline gene therapy study. The study will also screen participants for antibodies to a novel AAV vector to assess their suitability for inclusion in a Freeline gene therapy treatment study.

study_type: Observational

time_perspective: Other

lead_sponsor: Freeline Therapeutics

location_country:
Germany
Ireland
Italy
United Kingdom
Australia
Netherlands
Austria
United States
South Africa
Turkey
Canada
France

location_facility: Newcastle Hemophilia Comprehensive Care Centre

location_facility: Samsun Ondokuz Mayis University Medical Faculty

location_facility: University Hospitals Cleveland Medical Center

location_facility: Indiana Hemophilia and Thrombosis Center

location_facility: Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: University of Cape Town Clinical Research Center

location_facility: Citta della Salute e della Scienza di Torino - Ospedale le Molinette

location_facility: Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Universitaetsklinikum des Saarlandes und Medizinische Fakultaet der Universitaet des Saarlandes

location_facility: Lombardi Comprehensive Cancer Center at Georgetown University


title: Phase 2, Open-Label, Dose-Escalation and Dose-Expansion Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children With Achondroplasia: PROPEL 2

summary: This is a Phase 2, multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and efficacy of infigratinib, a fibroblast growth factor receptor (FGFR) 1-3-selective tyrosine kinase inhibitor, in children 3 to 11 years of age with Achondroplasia (ACH) who previously participated in the PROPEL study (Protocol QBGJ398-001) for at least 6 months. The study includes dose escalation with extended treatment, and dose expansion. The study also includes a PK Substudy to fully characterize the pharmacokinetics of infigratinib in children with ACH.

ReferenceCitation: Savarirayan R, De Bergua JM, Arundel P, McDevitt H, Cormier-Daire V, Saraff V, Skae M, Delgado B, Leiva-Gea A, Santos-Simarro F, Salles JP, Nicolino M, Rossi M, Kannu P, Bober MB, Phillips J 3rd, Saal H, Harmatz P, Burren C, Gotway G, Cho T, Muslimova E, Weng R, Rogoff D, Hoover-Fong J, Irving M. Infigratinib in children with achondroplasia: the PROPEL and PROPEL 2 studies. Ther Adv Musculoskelet Dis. 2022 Mar 21;14:1759720X221084848. doi: 10.1177/1759720X221084848. eCollection 2022.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_normalized: HAL

repository_institution: University of Bristol - Bristol Research

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

repository_institution: California Digital Library - eScholarship

publisher_dissemination: SAGE Publications

lead_sponsor: QED Therapeutics, Inc.

location_country:
United Kingdom
Australia
United States
Spain
Canada
France

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Manchester University Children's Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: Nemours Alfred I. Dupont Hospital for Children


acronym: TRANSCEND FL

summary:
This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL.

The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

This study is divided into three periods:

Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation;
Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29;
Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.

location_facility:
Local Institution - 551
Local Institution - 107
Local Institution - 500
Local Institution - 105
Local Institution - 351
Local Institution - 110
Local Institution - 112
Local Institution - 101
Local Institution - 108
Local Institution - 250
Local Institution - 102
Local Institution - 501
Local Institution - 109
Local Institution - 552
Local Institution - 301
Local Institution - 251
Local Institution - 252
Local Institution - 450
Local Institution - 115
Local Institution - 300
Local Institution - 103
Local Institution - 151
Local Institution - UNK-201
Local Institution - 200
Local Institution - 150
Local Institution - 553
Local Institution - 600
Local Institution - 550
Local Institution - 104
Local Institution - 114
Local Institution - 201
Local Institution - 502
Local Institution - 113
Local Institution - 350
Local Institution - 100
Local Institution - 111
Local Institution - 116
Local Institution - 117

title: A Phase 2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

location_country:
Germany
Italy
United Kingdom
Japan
Sweden
Austria
United States
Spain
Canada
France


title: A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects With Moderate and Severe Hepatic Impairment With Advanced Malignancies

summary:
This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat.

The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe hepatic (liver) impairment will be compared with participants with advanced malignancies and normal hepatic function.

An advanced malignancy is a cancer that has recurred (come back) after prior treatment or hasn't controlled with treatment.

The trial will also study the safety of the study drug in participants (how well it is tolerated).

lead_sponsor: Epizyme, Inc.

sponsor_collaborators:
Epizyme, Inc.
Sponsor GmbH

location_country:
Poland
Slovakia
Belgium
United States
France

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Oncology Consultants - Texas Medical Center


title: A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)

summary: The study's purpose is to see if the drug, abemaciclib, is safe and effective when given with other drugs to kill cancer cells. The study is open to children and young adults with solid tumors, including neuroblastoma, that did not respond or grew during other anti-cancer treatment. For each participant, the study is estimated to last up to 2 years.

location_country:
Italy
Australia
Japan
United States
Canada
France

location_facility: Intermountain - Primary Children's Hospital

location_facility: University of Louisville, Norton Children's Research Institute

location_facility: Children's Hospital of The King's Daughters

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Children's Hospital of Philadelphia (CHOP)

location_facility: Atrium Health - Carolinas Medical Center


acronym: Piranga

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.

location_facility: King College Hospital NHS Foundation Trust

location_facility: Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.

location_facility: Asan Medical Center / Clinical Trial Center

location_facility: Capital Medical University (CMU) - Beijing Ditan Hospital; Liver Center (Center for Liver Diseases)

location_facility: China Medical University Hospital; Internal Medicine

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

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

location_facility: Inje University Busan Paik Hospital; Clinical Trial Center

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

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Seoul National University College of Medicine, Liver Research Institute

location_facility: Nanfang Hospital, Southern Medical University

location_facility: University of Calgary; HSC- Faculty of Medicine

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

location_facility: Tokuda Hospital Sofia; Hematology department

location_facility: Hopital Brabois Adultes; Service Médecine Interne Hématologie

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

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

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

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

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


title: Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy

acronym: AMEND-CRT

summary: Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.

ipd_sharing_description: Available upon reasonable request after acceptance of publications.

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

location_country: Germany Poland Portugal Hungary Romania Brazil Switzerland Belgium Latvia Spain France

location_facility: Paul Stradins Clinical University hospital

location_facility: Groupements des hôpitaux de l'institut catholique de Lille

lead_sponsor_type: academique


lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.

The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.

Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

sponsor_collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_facility: Orszagos Onkologiai Intezet ( Site 0846)

location_facility: Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0442)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0227)

location_facility: Klinikum der Universitaet in Muenchen ( Site 0446)

location_facility: Hoag Memorial Hospital Presbyterian ( Site 0038)

location_facility: Karolinska Universitetssjukhuset ( Site 0784)

location_facility: UZA University Hospital Antwerp ( Site 0351)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0292)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0170)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638)

location_facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

location_facility: Hokkaido University Hospital ( Site 1163)

location_facility: Fondazione Giovanni Pascale Di Napoli ( Site 0544)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)

location_facility: University of Kentucky Markey Cancer Center ( Site 0015)

location_facility: Virginia Commonwealth University ( Site 0024)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0600)

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)

location_facility: National Cancer Center Hospital ( Site 1172)

location_facility: Hospital de Clínicas de Ribeirão Preto ( Site 0171)

location_facility: Fakultni Nemocnice Brno Bohunice ( Site 0912)

location_facility: Medizinische Universitat Innsbruck ( Site 0566)

location_facility: Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)

location_facility: Centro Medico Monte Carmelo ( Site 0289)

location_facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)

location_facility: University of the Ryukyus Hospital ( Site 1156)

location_facility: Aichi Cancer Center Hospital ( Site 1155)

location_facility: Harbin Medical University Cancer Hospital ( Site 1013)

location_facility: Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637)

location_facility: Zhejiang Provincial People's Hospital ( Site 1021)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 1167)

location_facility: Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)

location_facility: Willamette Valley Cancer Institute and Research Center ( Site 8000)

location_facility: Royal Brisbane and Women s Hospital ( Site 0972)

location_facility: Xiangya Hospital Central-South University ( Site 1009)

location_facility: Keimyung University Dongsan Medical Center ( Site 1066)

location_facility: Istituto di Candiolo - IRCCS ( Site 0546)

location_facility: Hospital das Clinicas da UFMG ( Site 0172)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0194)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)

location_facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)

location_facility: Euromedica General Clinic of Thessaloniki ( Site 0474)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 0913)

location_facility: Hospital Universitari Vall d Hebron ( Site 0634)

location_facility: University of North Carolina at Chapel Hill ( Site 0025)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 1025)

location_facility: Medizinische Universität Wien ( Site 0567)

location_facility: Peking Union Medical College Hospital ( Site 1001)

location_facility: Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)

location_facility: Monash Health-Monash Medical Centre ( Site 0970)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)

location_facility: Minnesota Oncology Hematology, PA ( Site 8007)

location_facility: Peter MacCallum Cancer Centre ( Site 0971)

location_facility: The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)

location_facility: McGill University Health Centre ( Site 0105)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: C.I.U. Hopital Ambroise Pare ( Site 0353)

location_facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0026)

location_facility: Legacy Good Samaritan Medical Center ( Site 0013)

location_facility: Centre Hospitalier Lyon Sud ( Site 0413)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)

location_facility: Hospital Nacional Daniel Alcides Carrion ( Site 0293)

location_facility: Ramathibodi Hospital, Mahidol University ( Site 1131)

location_facility: Texas Oncology-Austin Central ( Site 8006)

location_facility: Texas Oncology-Fort Worth Cancer Center ( Site 8001)

location_facility: Universitaetsklinik Leipzig ( Site 0456)

location_facility: Policlinico Universitario Gemelli ( Site 0538)

location_facility: National Taiwan University Hospital ( Site 1095)

location_facility: Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)

location_facility: Iwate Medical University Hospital ( Site 1165)

location_facility: Our Lady of the Lake Regional Medical Center. ( Site 0031)

location_facility: Osaka International Cancer Institute ( Site 1161)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166)

location_facility: Sanford Gynecology Oncology ( Site 0003)

location_facility: Sanford Bismarck Medical Center ( Site 0046)

location_facility: Princess Margaret Cancer Centre ( Site 0102)

location_facility: Srinagarind Hospital. Khon Kaen University ( Site 1132)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)

location_facility: Anhui Provincial Cancer Hospital ( Site 1007)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)

location_facility: IRCCS Ospedale San Raffaele ( Site 0539)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)

location_facility: National Cancer Center Hospital East ( Site 1159)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)

location_facility: Istituto Europeo di Oncologia ( Site 0536)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)

location_facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)

location_facility: Hospital Clinico Universitario Lozano Blesa ( Site 0630)

location_facility: Istituto Nazionale Tumori Regina Elena ( Site 0540)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)

location_facility: HonorHealth Research Institute - Biltmore ( Site 8009)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 1162)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0231)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 0754)

location_facility: Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)

location_facility: Instituto Nacional Do Cancer II ( Site 0173)

location_facility: Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)

location_facility: Medizinische Universitat Graz ( Site 0569)

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)

location_facility: Complejo Hospitalario de Jaen ( Site 0632)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 1097)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0816)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0845)

location_facility: Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 8002)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0017)

location_facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)

location_facility: Maharaj Nakorn Chiang Mai Hospital ( Site 1133)

location_facility: University of Colorado Health Sciences Center and Hospital ( Site 0028)

location_facility: General Hospital of Patras. St Andrews ( Site 0473)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)

location_facility: Saitama Medical University International Medical Center ( Site 1168)

location_facility: Universitaetsklinikum Freiburg ( Site 0454)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0228)

location_facility: The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)

location_facility: St John of God Subiaco Hospital ( Site 0969)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0023)

location_facility: University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)

location_facility: Texas Oncology-The Woodlands ( Site 8003)

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)

location_facility: I.U. Cerrahpasa Medical Faculty ( Site 0755)

title: A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)

type: Registry Identifier

location_country:
Germany
Ireland
Australia
Brazil
Japan
Thailand
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
United States
Ukraine
Belgium
China
Peru
Italy
Guatemala
Norway
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients With Moderate-to-Severe Asthma

summary:
The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma.

The secondary objectives of the study are:

To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma
To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Germany
Poland
United States
Spain
France

location_facility: IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz

location_facility: University of Iowa Hospitals & Clinics-Roy J. and Lucille A. Carver College of Medicine

location_facility: Palos Verdes Medical Group (PVMG); Peninsula Research Associates (PRA)

location_facility: Centrum Medycyny Oddechowej, Mroz Spolka Jawna

location_facility: The University of Texas Medical School at Houston

location_facility: CHU de Strasbourg - Nouvel Hopital Civil

location_facility: IKF Pneumologie GmbH & Co. KG - Institut fuer klinische Forschung Pneumologie Frankfurt (Clinical Research Centre Respiratory Medicine) to IKF Pneumologie Frankfurt GmbH & Co KG.

location_facility: Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)

location_facility: Lekarze Specjalisci - J. Malolepszy i Partnerzy


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Guys and Saint Thomas NHS Foundation Trust

location_facility: Arthritis and Osteoporosis Center - Orangeburg

location_facility: Arizona Arthritis and Rheumatology Research

location_facility: Clinica de Investigacion en Reumatologia y Obesidad

location_facility: North Georgia Rheumatology Group-Lawrenceville

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Medvin Clinical Research - Covina Office

location_facility: Clinical Investigation Specialists - Gurnee

location_facility: Inland Rheumatology and Osteoporosis Medical Group

title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis

location_country:
Germany
Poland
United Kingdom
Argentina
Netherlands
Mexico
Belgium
United States
Spain
France


title: A Phase 1 Open-label, Multicenter, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma

summary: An open-label, Phase 1 study of HPN217 to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma

lead_sponsor: Harpoon Therapeutics

location_country:
United States
Spain
France

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: The Centre Hospitalier Universitaire de Lille

location_facility: Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD)

location_facility: Josep Carreras Leukaemia Research Institute

location_facility: University of Rochester James P Wilmot Cancer Institute

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: University of Washington - Seattle Cancer Center Alliance


lead_sponsor: GlaxoSmithKline

summary: This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

location_country:
Germany
Poland
Australia
Brazil
Japan
Canada
France
Hungary
United States
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation


acronym: HAVEN 6

lead_sponsor: Hoffmann-La Roche

summary: This is a multicenter, open-label, single-arm study designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of emicizumab in participants with mild or moderate hemophilia A without inhibitors against factor VIII (FVIII).

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Klinikum der Universität München, Campus Innenstadt; Hämostaseologische Ambulanz/Hämophiliezentrum

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburze? Hemostazy i Chorób Wewn?trznych

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Hemophilia of Georgia Center for Bleeding & Clotting Disorders

location_facility: Cardiff and Vale NHS Trust; Arthur Bloom Haemophilia Centre

location_facility: University of Michigan, C.S. Mott Children's Hospital

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: Great Ormond street Hospital for Children NHS Foundation Trust; Haemophilia Centre

location_facility: Groupe Hospitalier Necker Enfants Malades

title: A Multicenter, Open-Label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients With Mild or Moderate Hemophilia A Without FVIII Inhibitors

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).

location_country:
Germany
Poland
United Kingdom
Netherlands
Belgium
United States
Spain
South Africa
Canada
France


lead_sponsor: Eli Lilly and Company

summary: This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: Seattle Children's Hospital Research Foundation

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Golisano Children's Hospital of Southwest Florida

title: A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Synovial Sarcoma

location_country:
Germany
Italy
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Spain
France


title: A Randomized, Open Label, Multicenter Phase II Study Evaluating the Efficacy and Safety of Capmatinib (INC280) Plus Pembrolizumab Versus Pembrolizumab Alone as First Line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer With PD-L1≥ 50%

summary: The purpose is to evaluate the efficacy and safety of the combination of capmatinib with pembrolizumab compared to pembrolizumab alone as first-line treatment for subjects with locally advanced or metastatic NSCLC who have PD-L1 expression ≥ 50% and have no EGFR mutation or ALK rearrangement. Capmatinib has demonstrated immunomodulatory activities when combined with an anti-PD1 antibody in preclinical tumor models irrespective of MET dysregulation. The combination of capmatinib with checkpoint inhibitors has been established to be tolerable and could provide additional clinical benefit to the subjects.

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:
Germany
Italy
India
Hong Kong
Australia
Japan
Netherlands
Belgium
Spain
Thailand
Greece
Malaysia
Taiwan
Czechia
Canada
France


title: A Dose-optimization, Exploratory Phase Ib/II Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143, When Given in Combination With the Anti-PD-1 Antibody Nivolumab in Patients With Specific Solid Tumors Who Have Progressed During or Immediately After Anti-PD-1/PD-L1 Treatment

summary:
Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability and pharmacokinetic (PK), by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab, as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments.

Part B (basket trial)- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose, overall and in each participant cohort (Cohort 1: small cell lung cancer [SCLC]; Cohort 2: squamous cell carcinoma of the head and neck [SCCHN]; Cohort 3: gastrointestinal (GI) cancers with known microsatellite instability-high/mismatch repair deficiency (MSI-H/MMRd) or other deoxyribonucleic acid (DNA) damage repair (DDR) abnormalities, including homologous recombination deficiency (HRD); Cohort 4: platinum-resistant epithelial ovarian cancer [EOC], endometrial cancer, primary peritoneal cancer (PPC) or cervical cancer, with known MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD).

lead_sponsor: Debiopharm International SA

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Methodist Hospital, Houston Methodist Cancer Center

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole


summary: The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)

title: An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201

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

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

location_country:
Poland
Slovakia
Hungary
Argentina
Denmark
Japan
United Kingdom
Belgium
United States
Spain
Turkey
Czechia
Canada
Russian Federation
France