title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study in Participants With Sarcoidosis-Associated Pulmonary Hypertension (SAPH) to Assess the Efficacy and Safety of Oral Selexipag.

acronym: SPHINX

summary: Oral selexipag is commercially available in several countries for the treatment of a particular group of pulmonary hypertension (PH) called pulmonary arterial hypertension (PAH). The aim of the present study is to investigate whether selexipag could be helpful to treat patients with another form of PH called sarcoidosis-associated pulmonary hypertension (SAPH).

ipd_sharing_description:
Actelion is a Janssen pharmaceutical company of Johnson & Johnson. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Actelion

location_country:
Italy
Brazil
United States
Netherlands
Germany
France
Belgium
Spain
Canada
United Kingdom

location_facility: Hospital de Messejana dr. Carlos Alberto Studart Gomes

location_facility: University Of Il Sarcoidosis Translational Advanced Research Center Star

location_facility: Albany Medical Center (AMC) - Pulmonary and Critical Care Medicine

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Wissenschaftliches Institut Bethanien für Pneumologie e.V

location_facility: GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel

location_facility: Klinikum Würzburg Mitte gGmbH Standort Missioklinik

location_facility: University of North Carolina at Chapel Hill

location_facility: Medical University of South Carolina (MUSC) - College of Medicine (COM)

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

location_facility: Louisiana State University Health Sciences Center

location_facility: St Vincents Lung, Sleep And Critical Care

location_facility: ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione

location_facility: Wayne State University/Detroit Medical Center

location_facility: University Health Network - Toronto General Hospital

location_facility: Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario 'A. Gemelli'

location_facility: Ospedale di Cattinara - Struttura complessa di Pneumologia

location_facility: Dorothy M. Davis Heart & Lung Research Institute

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: University of Texas Southwestern Medical Center

location_facility: Lewis Katz School of Medicine, Temple University


title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome

summary: This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

study_start_date_type: Actual

status: Enrolling by invitation

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Zogenix, Inc.

location_country:
Italy
United States
Sweden
Mexico
Netherlands
Germany
France
Poland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Sahlgrenska Universitetssjukhuset - Neurologkliniken

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: University Hospitals Cleveland Medical Center Rainbow Clinical Research Center

location_facility: Policlinico Universitario Agostino Gemelli, Università Cattolica del Sacro Cuore - Neuropsichiatria Infantile

location_facility: Ospedale ASST Grande Ospedale Metropolitano Niguarda

location_facility: Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin

location_facility: Great Ormond Street Hospital for Children-Neurology

location_facility: Clinical Integrative Research Center of Atlanta, Panda Neurology

location_facility: Istituto Gianna Gaslini, Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Massachusetts General Hospital for Children

location_facility: COMITATO ETICO della Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica Sacro Cuore

location_facility: Hopital Robert Debre - Paris - Neuropediatrie Et Maladies Met

location_facility: Ospedale Civile Maggiore di Borgo Trento - Ospedale della Donna e del Bambino - UOC Neuropsichiatria Infantile

location_facility: CHRU - HÃ´pital Roger Salengro - Neurophysiologie

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro Di Genova

location_facility: Hospital Civil De Guadalajara Fray Antonio Alcalde

location_facility: Hôpital Universitaire Des Enfants Reine Fabiola

location_facility: Epilepsie-zentrum Bethel im Krankenhaus Mara

location_facility: Pediatric Epilepsy & Research Center of Central Florida

location_facility: Skejby Sygehus or Aarhus University Hospital

location_facility: Comitato Etico Val Padana Istituti Ospitalieri Riuniti di Cremona

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù, - Dipartimento di Neuroscienze e Neuroriabilitazione

location_facility: U.O Malattie Neuromuscolari e Neurodegenerative - IRCCS Ospedale Pediatrico Bambino Gesu

location_facility: Institute of Neurology and Neurosurgery at St. Barnabas

location_facility: Kleinwachau - Sachsisches Epilepsiezentrum Radeberg

location_facility: Queen Elizabeth University Hospital Glasgow

location_facility: CHU Amiens - Hopital Sud - Service pédiatrique

location_facility: UT Southwestern Medical Center / Children's Medical Center Dallas

location_facility: Universitätsklinikum Jena Kinder - und Jugendklinik

location_facility: Fondazione Irccs Istituto Neurologico Carlo Besta Di Milano

location_facility: Comitato Etico per la Sperimentazione Clinica (CESC) delle Provincie di Verona e Rovigo

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

location_facility: Secretaria del CEIC Hospital Ruber Internacional

location_facility: MultiCare Institute for Research & Innovation

location_facility: HÃ´pital Necker - Enfants Malades - Service de Neurologie Pediatri

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VITAMED

location_facility: A.O.U Anna Meyer - Clinica di Neurologia Pediatrica

location_facility: Istituto Neurologica Carlo Besta - UOC Neuropsichiatria Infantile

location_facility: Borgo Trento, Ospedale Civile Maggiore, AOU Integrata di Ver

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


design_allocation: Randomized

status: Active, not recruiting

lead_sponsor: Merck Sharp & Dohme Corp.

enrollment_type: Actual

location_country:
Italy
United States
France
Japan
Germany
United Kingdom

location_facility: Freeman Hospital Newcastle upon Tyne Foundation NHS Trust ( Site 0092)

location_facility: Duke University Medical Center ( Site 0169)

location_facility: National Hospital Organization Kumamoto Medical Center ( Site 0122)

location_facility: Fred Hutchinson Cancer Research Center ( Site 0152)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0164)

location_facility: Policlinico Universitario Agostino Gemelli ( Site 0055)

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 0121)

location_facility: City of Hope National Medical Center ( Site 0158)

location_facility: The University of Texas MD Anderson Cancer Center ( Site 0154)

location_facility: Queen Elizabeth University Hospital [Glasgow, UK] ( Site 0096)

location_facility: John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0174)

location_facility: Universitaetsklinikum Heidelberg-Medizinische Klinik V ( Site 0042)

location_facility: Centre Hospitalier Universitaire Dupuytren ( Site 0182)

location_facility: Indiana Blood and Marrow Transplantation ( Site 0175)

location_facility: ASST Spedali Civili di Brescia ( Site 0052)

location_facility: University of California Davis Medical Center ( Site 0156)

location_facility: Universitaetsklinikum Muenster ( Site 0043)

location_facility: Jichi Medical University Hospital ( Site 0123)

location_facility: Fondazione PTV Policlinico Tor Vergata ( Site 0054)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0160)

location_facility: IRCCS Ospedale San Raffaele ( Site 0051)

ipd_sharing: Yes

type: EudraCT Number

type: Other Identifier

type: Registry Identifier

source: euctr

title: A Phase 3 Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Letermovir (LET) Prophylaxis When Extended From 100 Days to 200 Days Post-transplant in Cytomegalovirus (CMV) Seropositive Recipients (R+) of an Allogenic Hematopoietic Stem Cell Transplant (HSCT)

summary: The purpose of this study is to evaluate the safety and efficacy of letermovir (LET) versus placebo when extended from 100 days to 200 days post-transplant in cytomegalovirus (CMV) seropositive participants who received an allogenic hematopoietic stem cell transplant (HSCT). It is hypothesized that LET is superior to placebo in the prevention of clinically-significant CMV infection when LET prophylaxis is extended from 100 to 200 days.

status_simplified: Ongoing


title: Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients With Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer

summary: The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.

status: Completed

study_completion_date_type: Actual

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.

lead_sponsor: Eli Lilly and Company

location_country:
France
Japan
Belgium
Spain
Turkey
United States
United Kingdom
Korea, Republic of

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Severance Hospital Yonsei University Health System

location_facility: Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp

location_facility: Levine Cancer Institute- Carolinas Medical Center

location_facility: Centre de Lutte Contre le Cancer Leon Berard

location_facility: Grand Hopital de Charleroi-Site Notre-Dame

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

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

status_simplified: Completed


title: PROCADE: A Multinational Phase 3, Randomized, Double-Blind, Non-inferiority, Efficacy and Safety Study of Oral HC-1119 Versus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

summary:
This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC).

The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA.

Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.

status: Recruiting

ipd_sharing: No

lead_sponsor: Hinova Pharmaceuticals USA, Inc.

location_country:
Italy
United States
Netherlands
France
Poland
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hopital d'Instruction des Armées de Begin

location_facility: Urology Center of Colorado, 2777 Mile High Stadium Circle

location_facility: First Urology PSC, 101 Hospital Boulevard

location_facility: Clinical Research Center Spolka z Ograniczona

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: Urology San Antonio Stone Oak, 18915 Meisner Drive

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Hospital Regional Universitario de Malaga - Hospital Civil

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: First St. Petersburg State Medical University n.a. I.P Pavlov


title: A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer

summary: The main purpose of the study is to evaluate the safety and tolerability of M7824 in combination with chemotherapy.

design_allocation: Non-Randomized

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
United States
Belgium
France

location_facility: Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

location_facility: Hôpital de la Timone# - CPCEM CIC - Bat F 1er étage

location_facility: Baptist Health Lexington Oncology Associates

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha

location_facility: Centre Georges François Leclerc - Unité de Phase I

location_facility: Universitair Ziekenhuis Brussel - Geriatrie

location_facility: Compassionate Care Research Group Inc - Edinger Medical Group, Inc.

location_facility: Universitair Ziekenhuis Gent - Medical Oncology

location_facility: University of Maryland - DUPLICATE/Pediatric Surgery


lead_sponsor: Debiopharm International SA

location_country:
Finland
Greece
Romania
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Poland
Norway
Korea, Republic of
Netherlands
Philippines
Bulgaria
Singapore
United States
United Kingdom
Austria
Brazil
Czechia
Spain

acronym: The FUZE Clinical Trial

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: S.C Centrul de Oncologie Sf. Nectarie S.R.L.

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: SI V.T. Zaycev Institute of general & urgent surgery of National academy medical sciences of Ukraine, Department of purulent surgery

location_facility: Tan Tock Seng Hospital, Communicable Disease Centre

location_facility: TSBHI "Altai Territorial oncological dispensary"

location_facility: General Hospital of Athens of Chest Diseases "SOTIRIA"

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie

location_facility: Gachon University Gil Medical Center, CRC Room, 18F, Artificial intelligence hospital

location_facility: Complex Oncological Center - Plovdiv, EOOD

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: Hospital Clinico Universitario de Valencia

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: The Catholic University of Korea, St. Vincent's Hospital, CRC Room, 3F

location_facility: University Hospital Centre, Sestre Milosrdnice

location_facility: Taipei Veterans General Hospital, Medical Science & Technology Building

location_facility: Ajou University Hospital, CRC room, Clinical Trial Center

location_facility: Hospital de Caridade de Ijuí, Avenida David J Martins

location_facility: Seoul National University Bundang Hospital, Department of Oncology Medical office

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira, Avenida Doutor Arnaldo

location_facility: University of North Carolina at Chapel Hill

location_facility: Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Ironwood Cancer & Research Centers - Scottsdale

location_facility: Linear Clinical Research, B Block Sir Charles Gairdner Hospital

location_facility: Taichung Veterans General Hospital, The Radiation Oncology Department

location_facility: CHU Bordeaux - Hôpital Saint André, Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: Taipei Medical University Hospital (TMUH)

location_facility: Philippine General Hospital, Clinical Trial Unit Room 5, Medical Research Laboratory

location_facility: Cebu Doctors' University Hospital (CDUH), Research Office

location_facility: St. Luke's Medical Center, Human Cancer Biobank Research Center

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: LKH - Universitätsklinikum der PMU Salzburg

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

location_facility: Seoul National University Hospital (SNUH)

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

title: A Phase II Basket Study of the Oral Selective Pan-FGFR Inhibitor Debio 1347 in Subjects With Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3

summary: The primary objective of this study is to assess the efficacy of Debio 1347 in terms of objective response rate (ORR) in participants with solid tumors harboring fibroblast growth factor receptor (FGFR)1-3 gene fusion/rearrangement.


location_country:
Italy
Austria
United States
Germany
France
Israel
Hungary
Australia
Puerto Rico
Spain
Canada

location_facility: Centro de Endocrinologia Alcantara Gonzalez

location_facility: Barbara Davis Center for Childhood Diabetes

location_facility: Diabetologische Schwerpunktpraxis B. Scholz/Dr. B. Paschen

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Prairie Education and Research Cooperative

location_facility: Northwestern Feinberg School of Medicine

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Texas Diabetes and Endocrinology-Austin South

location_facility: John Muir Physician Network Clinical Research Center

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: Southern New Hampshire Diabetes and Endocrinology

location_facility: Groupe hospitalier mutualiste Les Portes du sud

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

location_facility: Rocky Mountain Diabetes and Osteoporosis Center

location_facility: Institut für Diabetesforschung Münster GmbH

location_facility: Gemeinschaftspraxis für innere Medizin und Diabetologie

location_facility: Tacoma Center for Arthritis Research, PS

title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog in Adults With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion

summary: The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).


title: GAIN Trial: A Randomized, Double-Blind, Placebo-Controlled Study of COR388 in Subjects With Alzheimer's Disease

summary: This is a randomized, double-blind, placebo-controlled study that will assess the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate AD dementia.

lead_sponsor: Cortexyme Inc.

location_country:
Netherlands
Poland
France
Spain
United States
United Kingdom

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Northeastern Pennsylvania Memory and Alzheimer's Center

location_facility: Disease Research & Neurology Center of Neurological Associates of Albany

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

location_facility: Memory Health Center at Summit Research Network

location_facility: Hôpitaux Universitaires de Strasbourg, Centre d'Investigation Clinique, Hôpital Hautepierre

location_facility: NZOZ Wrocławskie Centrum Alzheimerowskie

location_facility: Alzheimer's Research and Treatment Center

location_facility: ANI Neurology, PLLC dba Alzheimer's Memory Center

location_facility: Isala Zwolle - Interne geneeskunde Centrum voor ouderengeneeskunde

location_facility: The Cognitive Research Center of New Jersey

location_facility: RICE - The Research Institute for the Care of Older People

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Cognition Health Ltd. (private) Guildford

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Hospital Universitari General de Catalunya

location_facility: Anil Nair MD, Alzheimer's Disease Center

location_facility: University Hospital La Timone, Department of Neurology and Neuropsychology

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Brain Matters Research at the Kane Center

location_facility: Neurology Specialists of Monmouth County

location_facility: Memory Assessment and Research Centre, Moorgreen Hospital

location_facility: CHRU de Nancy Hôpital de Brabois Service de Gériatrie

location_facility: Houston Methodist Department of Neurology


title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.

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
Switzerland
Germany
France
Japan
Israel
Spain
Denmark
United States
United Kingdom
Korea, Republic of

location_facility: Hospital General Universitario Vall D Hebron

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: Hospital Regional Universitario de Malaga

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Universitario Y Politcnico de La Fe

location_facility: Severance Hospital Yonsei University Health System

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Multicare Institute For Research & Innovation

location_facility: University Medical Centre Hamburg-Eppendorf, Centre of Oncology

location_facility: Indiana University Health - Arnett Cancer Care

location_facility: University College London Hospitals (Uclh)

location_facility: Istituto Nazionale Tumori Regina Elena Irccs

location_facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Institut Universitaire Du Cancer de Toulouse Oncopole

location_facility: Seoul National University Bundang Hospital

location_facility: Chao Family Comprehensive Cancer Center University of California, Irvine

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Cancer Institute of Greenville Health System

location_facility: Virginia Oncology Associates-Lake Wright

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)

location_facility: University of Texas Southwestern Medical Center


title: A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

summary: The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, selected from the primary analysis results of Cohort 1. Cohort 2 will include participants in stable health with a history of urinary tract infection (UTI) in the past 5 years and will be included in the study to support the plan for late stage development of ExPEC vaccine.

primary_purpose: Other

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Netherlands
France
Belgium
Spain
United States

location_facility:
Johnson County Clin-Trials
PRA Health Sciences
CHU Nantes
Hosp. Univ. de La Princesa
Hosp. Univ. Marques de Valdecilla
Qps-Mra, Llc
Hosp. Reina Sofia
Rochester Clinical Research, Inc
ATC Pharma
CHRU Tours Hôpital Bretonneau
Hosp. Virgen Macarena
Clinical Pharmacology Unit
Coastal Carolina Research Center
Optimal Research
Chu Rennes - Hopital Pontchaillou
APHP - Hopital Bichat - Claude Bernard
Anima
Hopital Cochin
EB Flevo Research
Hosp. Univ. La Paz
Hosp. Del Mar
CHU Lyon Sud
Synexus Clinical Research US, Inc

intervention_type: Biological


title: A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency

summary: The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Russian Federation
Denmark
Ukraine
India
France
Japan
Poland
Thailand
Norway
Canada
Slovenia
Korea, Republic of
Switzerland
Hungary
Ireland
Algeria
Germany
United States
United Kingdom
Italy
Austria
Serbia
Israel
Spain
Estonia
Latvia


location_country:
Italy
United States
Chile
Switzerland
Germany
France
Thailand
Israel
Argentina
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan
Colombia

acronym: Pembrolizumab plus lenvatinib as second-line plus intervention for select solid tumors

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1402)

location_facility: National Cheng Kung University Hospital ( Site 3003)

location_facility: Cedars Sinai Medical Center ( Site 0003)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1203)

location_facility: Fundacion Arturo Lopez Perez ( Site 1201)

location_facility: Oncologos del Occidente S.A. ( Site 1106)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1701)

location_facility: University of Florida-Health Cancer Center-Orlando ( Site 0015)

location_facility: Christie NHS Foundation Trust ( Site 0805)

location_facility: Universitaetsklinikum Regensburg ( Site 0304)

location_facility: Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0604)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)

location_facility: Sir Charles Gairdner Hospital ( Site 0903)

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)

location_facility: Royal Brisbane and Women s Hospital ( Site 0901)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0007)

location_facility: Seoul National University Hospital ( Site 1000)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0309)

location_facility: National Taiwan University Hospital ( Site 3000)

location_facility: University of Wisconsin Carbone Cancer Center ( Site 0017)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0803)

location_facility: CHU de Quebec Universite de Laval ( Site 0206)

location_facility: Sunnybrook Research Institute ( Site 0207)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1600)

location_facility: City Clinical Oncology Center ( Site 1608)

location_facility: University of California Davis Comprehensive Cancer Center ( Site 0005)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)

location_facility: West Cancer Center - East Campus ( Site 0018)

location_facility: Royal Marsden Hospital (Sutton) ( Site 0800)

location_facility: Hospital Clinico Universidad de Chile ( Site 1200)

location_facility: Hospital Britanico de Buenos Aires ( Site 2109)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0009)

location_facility: Ospedale Regionale di Bellinzona e Valli ( Site 1703)

location_facility: Clinica Universitaria de Navarra ( Site 0704)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 1401)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0701)

location_facility: Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)

location_facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)

location_facility: Lehigh Valley Hospital- Cedar Crest ( Site 0047)

location_facility: Leningrad Regional Oncology Center ( Site 1609)

location_facility: Hospital Clinic i Provincial ( Site 0703)

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)

location_facility: Sanford Fargo Medical Center ( Site 0059)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 1102)

location_facility: Severance Hospital Yonsei University Health System ( Site 1001)

location_facility: Princess Margaret Cancer Centre ( Site 0202)

location_facility: Instituto de Oncologia de Rosario ( Site 2105)

location_facility: Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1202)

location_facility: Inselspital Universitaetsspital Bern ( Site 1705)

location_facility: Universitaetsklinikum Frankfurt ( Site 0306)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0403)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1403)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)

title: A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)

summary: The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.


status: Terminated

lead_sponsor: Millendo Therapeutics SAS

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

acronym: ZEPHYR

location_facility: Children's Hospitals and Clinics of Minnesota-Minneapolis

location_facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

location_facility: New York Presbyterian Morgan Stanley Children's Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital General Universitario de Alicante

location_facility: University of California - Irvine Medical Center

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: University of Texas Southwestern Medical Center

title: A Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi Syndrome

summary: This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS).


lead_sponsor: Nektar Therapeutics

location_country:
Italy
United States
Mexico
Netherlands
Germany
Spain
Finland
France
Greece
Israel
Belgium
Argentina
Australia
Portugal
Russian Federation
Canada
United Kingdom
Turkey

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Helsingin Yliopistollinen Keskussairaala - PPDS

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.

location_facility: Winship Cancer Institute, Emory University

location_facility: San Francisco VA Medical Center - NAVREF - PPDS

location_facility: Laura And Isaac Perlmutter Cancer Center

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Instituto Médico Especializado Alexander Fleming

location_facility: Innovative Clinical Research Institute, LLC

location_facility: Ankara University Medical Faculty - PPDS

location_facility: CAIPO Centro para la atención integral del paciente oncológico

location_facility: Southeastern Regional Medical Center - CTCA - PPDS

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Hôpital Privé TOULON/HYERES Sainte Marguerite

location_facility: Health Pharma Professional Research S.A de C.V.

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

location_facility: Fundacion Instituto Valenciano de Oncologia

ipd_sharing: Undecided

title: A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

summary: The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.


title: A Phase 1, Open-Label, Dose Finding Study of CC-95251, A Monoclonal Antibody Directed Against SIRPa, Alone and in Combination With Cetuximab or Rituximab in Subjects With Advanced Solid and Hematologic Cancers

summary: Study CC-95251-ST-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Parts B and C), first-in-human clinical study of CC-95251 in subjects with advanced cancers.

lead_sponsor: Celgene

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

location_facility: Derriford Hospital, University Hospitals Plymouth NHS Trust

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Istituto di Ematologia L. e A. Seragnoli-Azienda Ospedaliero Universitaria Policlinico S. Orsola M

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Washington University School of Medicine

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Providence Cancer Center/Earle A. Chiles Res. Inst.

location_facility: University of Pittsburgh Medical Center - Cancer Pavilion

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Rocky Mountain Cancer Centers, LLP [Aurora-COAU]

location_facility: NYU Langone Laura and Isaac Perlmutter Cancer Center

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: South Texas Accelerated Research Therapeutics

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Hospital Universitario Vall D hebron - PPDS


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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Netherlands
Germany
France
Czechia
Hungary
Belgium
Argentina
Spain
United States
United Kingdom

acronym: CONTRAIL I

title: A 12-month, Open-label, Multicenter, Randomized, Safety, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of an Anti-CD40 Monoclonal Antibody, CFZ533 vs. Standard of Care Control, in Adult de Novo Liver Transplant Recipients With a 12-month Additional Follow-up and a Long-term Extension (CONTRAIL I)

summary: The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 dose regimens in liver transplant recipients.


lead_sponsor: BeiGene

location_country:
Italy
Spain
France
Japan
Poland
Puerto Rico
Russian Federation
China
Turkey
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: The Second Hospital of Anhui Medical University

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

location_facility: Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.

location_facility: Hospital Regional Universitario de Malaga

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Tianjin Medical University General Hospital

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: General Hospital of Shenyang Military Region

location_facility: Osaka International Cancer Institute - Clinical Oncology

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Daping Hospital of The 3rd Military University

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: The First Affiliated Hospital of Bengbu Medical College

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

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: The Affiliated Hospital of Qingdao University

location_facility: FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Saitama Medical University International Medical Center

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Thomas Jefferson University Hospital - Central

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

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: RBIH "Ivanovo Regional Oncological Dispensary"

location_facility: SBIH " Volgograd Regional Clinical Oncological Dispensary # 1"

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Hiroshima City Hiroshima Citizens Hospita

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: SBIH of Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The First Hospital of China Medical University

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: University of California Davis Health System

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

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

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

location_facility: The First Hospital of Lanzhou University

location_facility: The First Affiliated Hospital of Guilin Medical University

location_facility: Xiangya Hospital Central South University

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Chinese PLA General Hospital Medical School of Chinese PLA

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary"

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

summary: This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line (1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.


lead_sponsor: MEI Pharma, Inc.

location_country:
Italy
Austria
Switzerland
Germany
France
Poland
Australia
Belgium
New Zealand
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Belfast Health and Social Care Trust - Belfast City Hospital

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Centro di Riferimento Oncologico di Aviano (CRO) IRCCS

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: The Catholic University of Korea-Seoul St. Marys Hospital

location_facility: Lewisham and Greenwich University Hospital Lewisham

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Centre for Haematology, Imperial College London

location_facility: Centre Hospitalier Universitaire (CHU) de Poitiers - Hôpital de la Miletrie

location_facility: Hospital Universitario Quiron Salud Madrid

location_facility: C H de la Cote Basque, Service d'Hematologie

location_facility: Norfolk and Norwich University Hospital NHS Foundation Trust

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori I.R.S.T.

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Investigative Clinical Research of Indiana LLC

location_facility: National Taiwan University Hospital NTUH

location_facility: IRCCS Regina Elena National Cancer Institute

title: A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)

summary: This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy


title: Open-label, Multicentre, Phase Ib Dose-escalation Study of MEN1611, a PI3K Inhibitor Combined With Trastuzumab With or Without Fulvestrant, in Subjects With PIK3CA Mutated HER2 Positive Locally Recurrent Unresectable (Advanced) or Metastatic (a/m) Breast Cancer Progressed to Anti-HER2 Based Therapy

summary: The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic HER2-positive breast cancer

lead_sponsor: Menarini Group

location_country:
Italy
France
Belgium
Spain
United States
United Kingdom

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Azienda Ospedaliero Universitaria Mater Domini


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor Rilzabrutinib (PRN1008) in Moderate to Severe Pemphigus

summary: This is a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (Blinded Treatment Period) followed by an Open-Label Extension Period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the Open-Label Extension Period, eligible patients may continue in a Long Term Extension Period of 48 weeks.

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

lead_sponsor: Principia Biopharma, a Sanofi Company

location_country:
Italy
Brazil
Serbia
Germany
Croatia
Bulgaria
France
Greece
Israel
Poland
Argentina
Australia
Spain
Turkey
United States
United Kingdom
Canada
Taiwan
Ukraine

location_facility: Central Recruiting (Principia Biopharma)


title: A Phase III, Open-label Study of Once Daily BI 201335 240 mg for 24 Weeks in Combination With Pegylated interferon-a (PegIFN) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN / RBV Treatment

summary: The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

ReferenceType: derived

ReferenceCitation: Foster GR, Ferenci P, Asselah T, Mantry P, Dufour JF, Bourlière M, Forton D, Maevskaya M, Wright D, Yoshida EM, García-Samaniego J, Oliveira C, Wright M, Warner N, Sha N, Quinson AM, Stern JO. Open-label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1-infected patients who failed placebo plus peginterferon and ribavirin. J Viral Hepat. 2016 Mar;23(3):227-31. doi: 10.1111/jvh.12485. Epub 2015 Nov 17.

name: Department of Hepatology; Barts and the London School of Medicine and Dentistry; Queen Mary University of London; London UK

family: Foster

full_name: G. R. Foster

given: G. R.

sequence: first

name: Department of Medicine III; University Hospital Vienna; Vienna Austria

family: Ferenci

full_name: P. Ferenci

given: P.

sequence: additional

name: Service d'Hépatologie, AP-HP; University Paris-Diderot and INSERM U773, CRB3; Hôpital Beaujon; Clichy France

family: Asselah

full_name: T. Asselah

given: T.

name: Department of Hepatology; The Liver Institute at Methodist Dallas Medical Center; Dallas TX USA

family: Mantry

full_name: P. Mantry

name: Department of Hepatology; University Clinic for Visceral Surgery and Medicine and University of Bern; Bern Switzerland

family: Dufour

full_name: J.-F. Dufour

name: Département d'Hépato-gastroentérologie; Hôpital Saint Joseph; Marseille France

family: Bourlière

full_name: M. Bourlière

given: M.

name: Department of Gastroenterology and Hepatology; St George's Hospital; London UK

family: Forton

full_name: D. Forton

given: D.

name: Hepatology Department; First Moscow State Medical University; Moscow Russia

family: Maevskaya

full_name: M. Maevskaya

name: Central Texas Clinical Research; Austin TX USA

family: Wright

full_name: D. Wright

name: University of British Columbia; Vancouver BC Canada

family: Yoshida

full_name: E. M. Yoshida

given: E. M.

name: Liver Unit; Hospital Universitario La Paz/Carlos III CIBERehd; Madrid Spain

family: García-Samaniego

full_name: J. García-Samaniego

given: J.

name: Department of Radiology; Hospital Infante D. Pedro; Aveiro Portugal

family: Oliveira

full_name: C. Oliveira

given: C.

name: Wellcome Trust Clinical Research Facility; Southampton UK

full_name: M. Wright

family: Warner

full_name: N. Warner

given: N.

name: Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield CT USA

family: Sha

full_name: N. Sha

family: Quinson

full_name: A.-M. Quinson

family: Stern

full_name: J. O. Stern

given: J. O.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Viral Hepatitis

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Boehringer Ingelheim

location_country:
Austria
United States
Switzerland
Spain
Germany
France
Japan
Romania
Belgium
Russian Federation
Portugal
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: 1220.48.1006 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0081 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8204 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1005 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3203 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0011 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.7001 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0065 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3201 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3312 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4914 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4911 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3303 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3316 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8119 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8206 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3503 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8121 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3305 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3410 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4901 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3411 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8201 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0017 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3412 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3509 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3502 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8113 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4407 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3501 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0087 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3409 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1012 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0078 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0029 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3311 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0063 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8117 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8802 China Medical University Hospital

location_facility: 1220.48.0013 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0039 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3304 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4404 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8116 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8207 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8205 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1016 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0095 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0023 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0058 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8118 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1009 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8114 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1007 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4913 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8106 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0012 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4302 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0018 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3204 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0071 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0091 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0027 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3301 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.7004 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0066 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4409 Boehringer Ingelheim Investigational Site


title: Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

summary:
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients.

The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.

ReferenceCitation: Bilton D, Pressler T, Fajac I, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Liu K, McGinnis JP 2nd, Eagle G, Gupta R, Konstan MW; CLEAR-108 Study Group. Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis. J Cyst Fibros. 2020 Mar;19(2):284-291. doi: 10.1016/j.jcf.2019.08.001. Epub 2019 Aug 23.

family: Bilton

full_name: Diana Bilton

given: Diana

family: Pressler

full_name: Tacjana Pressler

given: Tacjana

family: Fajac

full_name: Isabelle Fajac

given: Isabelle

family: Clancy

full_name: John Paul Clancy

given: John Paul

family: Sands

full_name: Dorota Sands

given: Dorota

family: Minic

full_name: Predrag Minic

given: Predrag

family: Cipolli

full_name: Marco Cipolli

given: Marco

family: Galeva

full_name: Ivanka Galeva

given: Ivanka

family: Solé

full_name: Amparo Solé

given: Amparo

family: Quittner

full_name: Alexandra L. Quittner

given: Alexandra L.

family: Liu

full_name: Keith Liu

given: Keith

family: McGinnis

full_name: John P. McGinnis

given: John P.

suffix: II

family: Eagle

full_name: Gina Eagle

given: Gina

family: Gupta

full_name: Renu Gupta

given: Renu

family: Konstan

full_name: Michael W. Konstan

given: Michael W.

family: Renner

full_name: Sabine Renner

given: Sabine

family: Knoop

full_name: Christiane Knoop

given: Christiane

family: Malfroot

full_name: Anne Malfroot

given: Anne

family: Dupont

full_name: Lieven Dupont

given: Lieven

family: Desager

full_name: Kristine Desager

given: Kristine

family: De Baets

full_name: Frans De Baets

given: Frans

family: Bosheva

full_name: Miroslava Bosheva

given: Miroslava

family: Nedkova

full_name: Vania Nedkova

given: Vania

location_country:
Italy
Austria
Sweden
Serbia
Netherlands
Germany
France
Bulgaria
Greece
Poland
Slovakia
Hungary
Belgium
Ireland
Spain
Denmark
Canada
United Kingdom


title: A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

ReferenceCitation: Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.

family: Delafont

full_name: Bruno Delafont

given: Bruno

name: KJC Statistics Ltd; Bramhall Cheshire UK

family: Carroll

full_name: Kevin Carroll

given: Kevin

family: Vilain

full_name: Claire Vilain

given: Claire

family: Pham

full_name: Emmanuel Pham

given: Emmanuel

journal_name: Pharmaceutical Statistics

lead_sponsor: Ipsen

location_country:
Italy
France
Czechia
Poland
Slovakia
Hungary
Belgium
Russian Federation
United States

location_facility: Southwestern Medical Center at Dallas University of Texas

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: Rancho Los Amigos National Rehabilitation Center

location_facility: National Institute for Medical Rehabilitation

location_facility: Associated Neurologist of Southern CT, PT

location_facility: Parkinson's Disease & Movement Disorders Center of Boca Raton


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

summary: This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.

lead_sponsor: PellePharm, Inc.

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

location_facility: Hospital of the University of Pennsylvania

location_facility: Clinical Trials Unit - The Skin Care Centre

location_facility: University of Miami Miller School of Medicine

location_facility: Hospital Universitiario Virgen de la Macarena

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University of Utah Midvalley Dermatology

location_facility: Klinik und Poliklinik fur Dermatologie und Allergologie

location_facility: Stanford University, Department of Dermatology

location_facility: University of Michigan, Dept of Dermatology

location_facility: Maastricht University Medical Center - Dept of Dermatology

location_facility: University of Minnesota, Department of Dermatology

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Ospedale Vanvitelli-University della Campania-Dermatologia Edificio 9


ipd_sharing_description: Please refer data queries to DataSharing@biogen.com.

lead_sponsor: Biogen

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

acronym: NOVA

location_facility:
Reseach Site
Research Site

title: A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

summary:
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) in participants who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of EID in participants who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.

Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.


title: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)

summary: The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.

lead_sponsor: ADC Therapeutics S.A.

location_facility: Centre Hospitalier Universitaire De Poitier - Hopital De La Miletrie - Hopital Jean Bernard

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: University of California Irvine Health Chao Family Comprehensive Cancer Center

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

location_facility: Centre Hospitalier Universitaire de Rennes Hôpital Pontchailou

location_facility: IRCCS istituto Clinico Humanitas U.O. di Oncologia ed Ematologia

location_facility: The Blood and Marrow Transplant Group of Georgia

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Azienda Unita Sanitaria Locale de Ravenna

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Georgia Cancer Center at Augusta University

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Abertawe Bro Morgannwg University Health Board


title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy at Risk of Progressing to End-stage Renal Disease (NefIgArd)

acronym: Nefigard

summary: The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

ReferenceType: background

ReferenceCitation: Fellström BC, Barratt J, Cook H, Coppo R, Feehally J, de Fijter JW, Floege J, Hetzel G, Jardine AG, Locatelli F, Maes BD, Mercer A, Ortiz F, Praga M, Sørensen SS, Tesar V, Del Vecchio L; NEFIGAN Trial Investigators. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. 2017 May 27;389(10084):2117-2127. doi: 10.1016/S0140-6736(17)30550-0. Epub 2017 Mar 28.

lead_sponsor: Calliditas Therapeutics AB

location_country:
Italy
Sweden
Spain
Germany
Finland
France
Czechia
Greece
Korea, Republic of
Poland
Belgium
Argentina
Australia
Belarus
Turkey
United States
United Kingdom
Canada
Taiwan

location_facility: Leicester General Hospital, John Walls Renal Unit, Gwendolen Rd

location_facility: CISSS de la Monteregie-Centre-Hopital Charles LeMoyne, Room E-304, 3120 Taschereau Blvd

location_facility: Fakultni nemocnice Brno, Interni gastroenterologicka klinika, Jihlavska 20

location_facility: Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu

location_facility: Renal Disease Research Institute, 1250 Eighth Av. #135

location_facility: Western Health, Western Hospital-Sunshine Hospital, 176 Furlong Rd, Level 3, WHCRE Building

location_facility: Uppsala University Hospital, Dept of Nephrology, ing 30, plan 5

location_facility: Grodno Regional Clinical Hospital, 52 Bulvar Leninskogo Komsomola

location_facility: Uniwersyteckie Centrum Kliniczne-Szpital Gdanskiego Uniwersytetu Medycznego

location_facility: National Cheng Kung University Hospital, No 138 Sheng Li Rd

location_facility: Stanford University Medical Center, 777 Welch Rd

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik II, Pauwelsstrasse 30

location_facility: Sahlgrenska University Hospital, Njurmottagningen, Vita Stråket 12

location_facility: University Hospital of Larissa Medical School, Nefrology Clinic, Mezourlo

location_facility: Centre Hospitalier Universitaire de Liege, Nephrology Dept. Domaine Universitaire de Sart-Tilman

location_facility: Istituti Clinici Scientifici Maugeri Spa-Societa Benefit, Div. di Nephrologia ed Emodialist, Via S. Maugeri 10

location_facility: ASST di Lecco, Presidio Ospedaliero Alessandro Manzoni, Via dell´Eremo 9/11

location_facility: CHUQ-L'Hotel Dieu de Quebec, 11 côte du Palais

location_facility: Southeastern Nephrology Associates-Wilmington, 1302 Medical Center Drive

location_facility: Vancouver Coastal Health Authority, Gordon and Leslie Diamond Health Care Centre, 5 th floor, Diamond Building

location_facility: Hospital Clinic Barcelona, Escalera 12, Planta 5, Calle Villaroel 170

location_facility: Universitaetsklinikum Regensburg, Abteilung für Nephrologie, Franz-Josef-Strauss Allee 11

location_facility: Hippokration General Hosp of Thessaloniki, Nephrology Clinic, 49 Konstantinoupoleos Str

location_facility: Cliniques Universitaires Saint-Luc, Nephrology Dept, Av. Hippocrate 10

location_facility: Lapeyronie Hospital, Univ Hospital Montpellier, 371 Av. du Doyen Gaston Giraud

location_facility: Tampere University Hospital, P O Box 2000, Munuaiskeskus, Erakennus, 1. kerros

location_facility: Hospital Privado-Centro Medico de Cordoba, Naciones Unidas 346, Nefrologia piso 1

location_facility: Northwestern University the Feinberg School of Medicine, 633 North St. Clair

location_facility: Istanbul University Cerrahpasa, Medical Faculty-Dept of Internal Disease, Fatih-Cerrahpasa, Kocamustafapasa Caddesi No 53

location_facility: China Medical University Hospital, No 2 Yude Rd

location_facility: Dong-A University Hospital, Won Suk An, 26 Daesingongwon-Ro Seogu

location_facility: Ospedale San Carlo Borromeo, Via Pio II, 3

location_facility: Fakultni nemocnice Hradec Kralove, Sokolska 581

location_facility: Mountain Kidney & Hypertension Assoc, 10 McDowell St

location_facility: Erciyes University Faculty of Medicine,Semiha Kibar Organ Nakli ve Dyaliz Hastanesi, Kosk Mah. prof dr Turhan Feyziogly Cad. no 42

location_facility: Hospital Universitario Fundacion Alcorcon, C/Budapest 1

location_facility: Kaohsiung Medical Univ Chung-Ho Memorial Hospital

location_facility: Hospital Maisonneuve-Rosemont, CNIB 3rd Floor, 1929 Bayview Avenue

location_facility: Los Angeles Biomedical Research Institute at HUMC, 1124 W. Carson Street

location_facility: Oregon Health & Science University, 3181 SW Sam Jackson Park Rd

location_facility: University General Hospital of Patras, Rio

location_facility: 4-th N.E. Savchenko City Clinical Hospital, 110, R. Luxemburg str.

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Oddzial Kliniczny Nefrologiczny, Hipertensjologii i Chorob Wewnetrznych, ul. Zolnierska 18

location_facility: Queen Elizabeth University Hosp-Glasgow, Glasgow Clin Research Facility 5th floor, Institute of Neurosciences

location_facility: University of Alabama at Birmingham, 1720 2nd Ave South

location_facility: University Hospital Erasmus (Brussels), Recherche Clinique Nephrologie Transplantation, Route de Lennik 808

location_facility: Interior Health-Kelowna General Hosp (IH KGH), 2268 Pandosy Str.

location_facility: University of Minnesota, 717 Delaware St. SE

location_facility: Nephrology Associates, P.C., 28 White Bridge Rd

location_facility: University General Hospital of Ioannina, Nephrology Clinic, Leof. Stavros Niarchou

location_facility: Hospital Universitario Vall d´Hebron, Passeig Vall d´Hebron 119-129

location_facility: Toronto General Hospital, University Health Network, 200 Elizabeth St, 8 N-849

location_facility: Clinical Research Consultants, LLC, 3930 Washington St

location_facility: Chung-Ang University Hospial, 102 Heukseok-ro, Dongiak-gu

location_facility: Metro South Hospital and Health Service via Princess Alexandra Hospital, Dept of Nephrology, 199 Ipswich Rd.

location_facility: Queen Elizabeth II Health Sciences Centre, 1276 South Park St

location_facility: Fakultni nemocnice Olomouc, I.P. Pavlova 185/6

location_facility: Northshore University Health System, 2650 Ridge Av.

location_facility: Hospital Britanico de Buenos Aires, Pedriel 74

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny, Uniwersytetu Medycznego w Lodzi, ul Pomorska 251

location_facility: Chungnam National University Hospital, 282 Munhwa-ro, Jung-gu

location_facility: Hallym University Sacred Heart Hospital,22 Gwanpyeong-ro 170 beon-gil, Dongan-gu, Anyang-si

location_facility: Box Hill Hospital, Dept of Renal Medicine, Arnold Str 5

location_facility: Chu St Etienne-Hopital Nord, Service de Nephrologie Dialyse Transplantation renale, Av. Albert Raimond

location_facility: Karolinska University Hospital-Huddinge, Njur-KBC M87

location_facility: Washington Nephrology Associates-Washington DC, 730 24th Street NW

location_facility: CHU Grenoble-Hopital Michallon, Service Nephrologie-Hemodialyse-Aphereses-Transplantation Renale, Boulevard de la Chantourne CS 10217

location_facility: Southeastern Nephrology-Whiteville, 800 Jefferson St

location_facility: Hopital Bichat-Claude Bernard, Service de Nephrologie, 46 rue Henri Huchard

location_facility: Allegheny General Hospital, 4800 Friendship Av.

location_facility: Hospital General Universitario Gregorio Maranon, Servicio de Nefrologica, C/Dr. Esquerdo 46

location_facility: Southmead Hospital, Southmead Rd, Westbury-on-Trym

location_facility: Clinico de Nefrologia, Urologia Y Enfermedades Cardiovasculares, Av. Gdor Freyre 3074

location_facility: Columbia Univ Medical Center, Div of Nephrology, 51 Audubon Av

location_facility: University Clinic Munich, LMU-Inner City Medical Polyclinic, Nephrologisches Zentrum, Medizinische Klinik und Poliklinik IV

location_facility: Sonomed Sp. z.o.o. ul. Bandurskiego 98/U12

location_facility: General Hospital of Athens-Laiko, Nephrology Clinic, 17 Agiou Thoma Street

location_facility: Vseobecna fakultni nemocnice v Praze, Klinik nefrologie, U Nemocnice 499/2

location_facility: Seoul St. Mary´s Hospital, 222 Banpo-Daero, Seocho-gu

location_facility: Centre Hospiitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord

location_facility: Universitaetsklinikum Erlangen, Medizinisches Klinik 4, Ulmenweg 18

location_facility: Centre Hospitalier Boulogne sur Mer, 4eme etage Batiment Administratif, Allee Jacques Monod

location_facility: Royal Inland Hospital, Kidney Clinic, 7 South, 311 Columbia Street

location_facility: Universitaetsklinikum Heidelberg-Nephrologie, Renal Clinic, Im Neuenheimer Feld 162

location_facility: University of North Carolina at Chapel Hill, Clinical & Translational Research Centre

location_facility: Gomel Regional Clinical Hospital, 5 Brat'ev Lizukovyh str.

location_facility: University of Kentucky Medical Center, 800 Rose St, Pavillion H 3rd floor

location_facility: Hospital 12 de Octubre, Residencia General (Sotano 1)-Area de Ensayos Clinicos, Avda. Cordoba s/n

location_facility: Westmead Hospital, Dept of Renal Medicine, Hawkesbury Rd.

location_facility: Yale University School of Medicine, 330 Cedar Street

location_facility: Hospital Universitari Arnau de Vilanova, Avenida Alcalde Rovire Roure 80

location_facility: Melbourne Health, Royal Melbourne Hospital, Dept of Nephrology,Grattan Str.

location_facility: University of Manchester, Manchester Royal Infirmary, Oxford Rd

location_facility: Kyungpook National University Hospital, 130 Dongdeok-ro Jung-gu

location_facility: Icahn School of Medicine at Mount Sinai-James J. Peters VA Medical Center, One Gustave L. Levy Place

location_facility: Omega Research Maitland, 7912 Forest City Rd.

location_facility: Prince of Wales Hospital, Nephrology Dept, Parkes 3 West

location_facility: University Hospital of Heraklion, Nephrology Clinic, Diastaurosi Staurakion-Vouton

location_facility: Fakultni nemocnice Kralovske Vinohrady, Linterni klinika, Srobarova 1150/50

location_facility: The Ohio State University (OSU), Wexner Medical Center, 410 West 10th Av.

location_facility: Gloucestershire Royal Hospital, Great Western Rd

location_facility: Brest Regional Hospital, 7 Meditsinskaya str.

location_facility: Universitatsklinik Schleswig-Holstein-Campus Lubek, Medizinische Klinik I, Nephrologie, Ratzeburger Allee 160

location_facility: Western Nephrology and Metabolic Bone Disease, PC-Westerminster, 8410 Decatur St.

location_facility: St James´s University Hospital, Beckett St.

location_facility: Universitetssjukhuset Linköping, Njurmedicinska kliniken

location_facility: General Hospital of Nikaia Ag. Panteleimon, Nephrology Clinic, Mantouvalou 3 Str.

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden, Medizinische Klinik III, Nephrologie, Fetscherstr. 74

location_facility: Kidney Care and Transplant Services of New England, PC, 354 Birnie Av.

location_facility: Ege University Med Faculty Dept of Internal Disease, Div of Nephrology

location_facility: Thomas Jefferson University, 211 S. 9th Street

location_facility: University Hospital Gent, Dept of Medical Nephrology, Corneel Heymanslaan 10

location_facility: Cleveland Clinic, Glickman Urological & Kidney Institute, 9500 Euclid Av.

location_facility: Hospital Universitario Austral, Unidad de Investigacion Clinica, Av. J.D. Peron 1500, piso 4

location_facility: Centre Hospitalier de Valenciennes, Service de Nephrologie-Medecine Interne, Av. Desandrouin BP 379

location_facility: University of Colorado Health Science Center, 1200 East 19th Av.

location_facility: Sanatorio Allende, Hipolito Yrigoyen 384, 2 Piso

location_facility: Austin Health, Dept of Nephrology, 145 Studley Rd.

location_facility: Cukurova University Medical Faculty, Dept of Internal Disease, Div of Nephrology, Balcali

location_facility: Kocaeli University Medical School-Internal Medicine, Nephrology, Umuttepe Yerleskesi

location_facility: Danderyds sjukhus, Njurmedicinska kliniken

location_facility: Helsinki University Central Hospital (HUCH), Nephrology Clinic, Meilahti Triangle Hospital


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
Peru
Mexico
Germany
France
Bulgaria
Japan
Israel
Poland
Slovakia
Hungary
Russian Federation
Spain
Turkey
United States

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Kaiser Permanente Riverside Medical Center

location_facility: Ankara Numune Training and Research Hospital; Department Of Ophthalmology

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

location_facility: National Defense Medical College Hospital

location_facility: Retina Consultants of Southern California

location_facility: Ambulatory - Medical Center for Specialized Medical Assistance - "Eye Clinic Sveta Petka" Ltd

location_facility: Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

location_facility: Beetham Eye Institute, Joslin Diabetes Center

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: University of California, Davis, Eye Center

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia

location_facility: California Eye Specialists Medical group Inc.

location_facility: Instituto Mexicano de Oftalmologia I.A.P.

location_facility: VISSUM Instituto Oftalmológico de Alicante

location_facility: Medical Center for Eye Health - Focus Ltd

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266

location_facility: University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki

location_facility: Hospital Universitario Puerta de Hierro; Servicio de oftalmologia

location_facility: Hospital Clinic Barcelona; Servicio Oftalmologia

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

location_facility: Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: Centre Odeon; Exploration Ophtalmologique

location_facility: University of Utah; Division of Gastroenterology/Hepatology

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Hospital Universitario de Gran Canaria; Servicio de oftalmologia

location_facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Spec. Ophth. Hospital for Active Treatment- Academic Pashev

location_facility: Shiga University Of Medical Science Hospital

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Tokyo Women's Medical University Hospital

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

intervention_type: Procedure


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

lead_sponsor: AstraZeneca

location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Canada
Korea, Republic of
South Africa
Bulgaria
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain

acronym: Expedition

title: A 54-Week, Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)

summary: The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.


title: Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)

summary: This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

ReferenceCitation: Kiladjian JJ, Zachee P, Hino M, Pane F, Masszi T, Harrison CN, Mesa R, Miller CB, Passamonti F, Durrant S, Griesshammer M, Kirito K, Besses C, Moiraghi B, Rumi E, Rosti V, Blau IW, Francillard N, Dong T, Wroclawska M, Vannucchi AM, Verstovsek S. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. Lancet Haematol. 2020 Mar;7(3):e226-e237. doi: 10.1016/S2352-3026(19)30207-8. Epub 2020 Jan 23.

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

family: Zachee

full_name: Pierre Zachee

given: Pierre

family: Hino

full_name: Masayuki Hino

given: Masayuki

family: Pane

full_name: Fabrizio Pane

given: Fabrizio

family: Masszi

full_name: Tamas Masszi

given: Tamas

family: Harrison

full_name: Claire N Harrison

given: Claire N

family: Mesa

full_name: Ruben Mesa

given: Ruben

family: Miller

full_name: Carole B Miller

given: Carole B

family: Passamonti

full_name: Francesco Passamonti

given: Francesco

family: Durrant

full_name: Simon Durrant

given: Simon

family: Griesshammer

full_name: Martin Griesshammer

given: Martin

family: Kirito

full_name: Keita Kirito

given: Keita

family: Besses

full_name: Carlos Besses

given: Carlos

family: Moiraghi

full_name: Beatriz Moiraghi

given: Beatriz

family: Rumi

full_name: Elisa Rumi

given: Elisa

family: Rosti

full_name: Vittorio Rosti

given: Vittorio

family: Blau

full_name: Igor Wolfgang Blau

given: Igor Wolfgang

family: Francillard

full_name: Nathalie Francillard

given: Nathalie

family: Dong

full_name: Tuochuan Dong

given: Tuochuan

family: Wroclawska

full_name: Monika Wroclawska

given: Monika

family: Vannucchi

full_name: Alessandro M Vannucchi

given: Alessandro M

family: Verstovsek

full_name: Srdan Verstovsek

given: Srdan

ReferenceCitation: Kiladjian JJ, Guglielmelli P, Griesshammer M, Saydam G, Masszi T, Durrant S, Passamonti F, Jones M, Zhen H, Li J, Gadbaw B, Perez Ronco J, Khan M, Verstovsek S. Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies. Ann Hematol. 2018 Apr;97(4):617-627. doi: 10.1007/s00277-017-3225-1. Epub 2018 Feb 2.

ReferenceCitation: Verstovsek S, Harrison CN, Kiladjian JJ, Miller C, Naim AB, Paranagama DC, Habr D, Vannucchi AM. Markers of iron deficiency in patients with polycythemia vera receiving ruxolitinib or best available therapy. Leuk Res. 2017 May;56:52-59. doi: 10.1016/j.leukres.2017.01.032. Epub 2017 Jan 31.

ReferenceCitation: Verstovsek S, Vannucchi AM, Griesshammer M, Masszi T, Durrant S, Passamonti F, Harrison CN, Pane F, Zachee P, Kirito K, Besses C, Hino M, Moiraghi B, Miller CB, Cazzola M, Rosti V, Blau I, Mesa R, Jones MM, Zhen H, Li J, Francillard N, Habr D, Kiladjian JJ. Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial. Haematologica. 2016 Jul;101(7):821-9. doi: 10.3324/haematol.2016.143644. Epub 2016 Apr 21.

repository_institution: University of Florence - Florence Research

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Vannucchi AM, Kiladjian JJ, Griesshammer M, Masszi T, Durrant S, Passamonti F, Harrison CN, Pane F, Zachee P, Mesa R, He S, Jones MM, Garrett W, Li J, Pirron U, Habr D, Verstovsek S. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015 Jan 29;372(5):426-35. doi: 10.1056/NEJMoa1409002.

title: Ruxolitinib versus Standard Therapy for the Treatment of Polycythemia Vera

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Japan
Thailand
Hungary
Belgium
Argentina
Australia
China
Russian Federation
Turkey
Canada
United Kingdom
Korea, Republic of


summary: This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

location_country:
Italy
Austria
Brazil
Mexico
Germany
France
Puerto Rico
Spain
United States
United Kingdom
Canada


title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)

summary:
The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up

lead_sponsor: Eli Lilly and Company

location_country:
Malaysia
Greece
Romania
Australia
Russian Federation
Taiwan
Ukraine
India
Croatia
France
Japan
Lithuania
Poland
Slovakia
Argentina
Korea, Republic of
Colombia
South Africa
Bulgaria
Sri Lanka
Hungary
Germany
United States
Brazil
Mexico
New Zealand
Spain

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.