title: Open-Label Extension Study of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

summary: The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.

location_country:
Germany
Poland
Portugal
Hungary
United Kingdom
Mexico
Belgium
United States
Spain
Czechia
Canada
Ukraine
Russian Federation
France

location_facility: Hospital Senhora da Oliveira - Guimarães, E.P.E

location_facility: Vital Prospects Clinical Research Institute PC - CRN

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: University of Missouri Health Care System

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Centro Hospitalar do Algarve - Hospital de Portimao

location_facility: Stredomoravska nemocnicni a.s. - odstepny zavod Nemocnice Prostejov

location_facility: State Institution Institute of Otolaryngology n.a. Prof. O.S.

location_facility: Nouvel Hopital Civil; Pole de Pathologie Thoracique

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Municipal Institution "City Clinical Hospital #3"

location_facility: CHUS - H. Clinico U. de Santiago; Servicio de Farmacia

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

location_facility: Municipal Health Care Institution Regional clinical specialized dispensary of radiation protection

location_facility: Central Clinical Hospital With Polyclinic of President Administration of RF

location_facility: Allergy Associates Research Center LLC - CRN

location_facility: Charie Campus Mitte; Hals, Nasen, Ohrenheilkunde

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

location_facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: Banner University of Arizona Medical Center

location_facility: Synexus Affiliate - Clinic Med s.j. Bialystok

location_facility: Fakultni nemocnice Hradec Kralove, Chirurgicka klinika

location_facility: Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro; Servicos Farmaceuticos

location_facility: Medical University of South Carolina Hospital

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Bayer

summary:
FORT-2 is designed to evaluate safety, efficacy, RP2D and PK of rogaratinib in combination with atezolizumab in patients with untreated FGFR-positive urothelial carcinoma. The study originally comprised two separate parts: Phase 1b (Part A) and Phase 2 (Part B). The study parts differ in design, objectives, and treatment.

The primary objectives of this Phase 1b study (Part A) are to determine the safety, tolerability, RP2D and pharmacokinetics of rogaratinib in combination with atezolizumab in these patients.

The primary objective of the Part B is to compare progression-free survival (PFS) according to RECIST v1.1 of rogaratinib in combination with atezolizumab over placebo in combination with atezolizumab in untreated patients with FGFR-positive locally advanced or metastatic urothelial carcinoma.

Of note, patients who participate in Part A are not allowed to participate in Part B.

Part B will be initiated once the data from Part A supports continuation of the study, even if this occurs prior to primary completion of Part A. The sponsor may decide not to continue the study as a whole after completion of Part A if the data do not support further development.

Part B of the study will no longer be conducted.

ReferenceType: derived

ReferenceCitation: Grunewald S, Politz O, Bender S, Heroult M, Lustig K, Thuss U, Kneip C, Kopitz C, Zopf D, Collin MP, Boemer U, Ince S, Ellinghaus P, Mumberg D, Hess-Stumpp H, Ziegelbauer K. Rogaratinib: A potent and selective pan-FGFR inhibitor with broad antitumor activity in FGFR-overexpressing preclinical cancer models. Int J Cancer. 2019 Sep 1;145(5):1346-1357. doi: 10.1002/ijc.32224. Epub 2019 Mar 13.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Hospital General Universitario de Valencia

location_facility: Barbara Ann Karmanos Cancer Institute - Detroit

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

status: Active, not recruiting

title: An International, Multicenter, Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab as First-line Treatment in Cisplatin-ineligible Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

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

study_completion_date_type: Anticipated

location_country:
Germany
Italy
Japan
Austria
United States
Korea, Republic of
Spain
France

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema

acronym: APeX-S

summary: This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

ReferenceCitation: Riedl MA, Neville D, Cloud B, Desai B, Bernstein JA. Shared decision-making in the management of hereditary angioedema: An analysis of patient and physician perspectives. Allergy Asthma Proc. 2022 Sep 1;43(5):397-405. doi: 10.2500/aap.2022.43.220050. Epub 2022 Jul 12.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Oceanside Publications Inc.

ReferenceCitation: Farkas H, Stobiecki M, Peter J, Kinaciyan T, Maurer M, Aygoren-Pursun E, Kiani-Alikhan S, Wu A, Reshef A, Bygum A, Fain O, Hagin D, Huissoon A, Jesenak M, Lindsay K, Panovska VG, Steiner UC, Zubrinich C, Best JM, Cornpropst M, Dix D, Dobo SM, Iocca HA, Desai B, Murray SC, Nagy E, Sheridan WP. Long-term safety and effectiveness of berotralstat for hereditary angioedema: The open-label APeX-S study. Clin Transl Allergy. 2021 Jun;11(4):e12035. doi: 10.1002/clt2.12035.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

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

repository_normalized: HAL

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

unpaywall_oa_status: gold

lead_sponsor: BioCryst Pharmaceuticals

location_country:
Germany
Poland
New Zealand
Australia
Serbia
France
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
North Macedonia
Italy
United Kingdom
Austria
Korea, Republic of
Spain
South Africa
Israel

location_facility:
Study Center
Study center

status_simplified: Completed


title: A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

summary:
This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and G/R CHOP or Pola-R-CHP in participants with untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts:

Part I: Dose finding in participants with r/r NHL; test use of G vs R in Cycle 1
Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with untreated DLBCL (>18 years of age with an age-adjusted International Prognostic Index (IPI) of 2-5). Glofitamab will be studied in combination with R-CHOP and Pola-R-CHP.

design_allocation: Randomized

enrollment_type: Anticipated

lead_sponsor: Hoffmann-La Roche

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

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

location_facility: West Virginia University; Health Sciences Center

location_facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: UO Ematologia, Ospedale S.Maria delle Croci

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

location_facility: Universitätsklinikum Erlangen, Translational Research Center (TRC), Medizin 5

location_facility: Universitätsklinikum Würzburg; Studienzentrale Hämatologie/Onkologie

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: Hopital Hotel Dieu Et Hme; Clinique Hematologie

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

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz


title: A Phase 1/2 Study of Relatlimab (Anti-LAG-3 Monoclonal Antibody) Administered in Combination With Both Nivolumab (Anti-PD-1 Monoclonal Antibody) and BMS-986205 (IDO1 Inhibitor) or in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

summary: The purpose of this study is to demonstrate the safety and preliminary activity with triple combinations of relatlimab in combination with nivolumab and BMS-986205, or in combination with nivolumab and ipilimumab in immunotherapy-naive and pretreated populations across select advanced tumor types.

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United Kingdom
Australia
Switzerland
United States
Spain
France

location_facility:
Hopital De La Timone
Institut Claudius Regaud
Local Institution - 0003
Local Institution - 0021
Local Institution - 0018
Local Institution - 0011
Local Institution - 0009
Institute Gustave Roussy
Local Institution - 0007
Local Institution - 0005
Local Institution - 0014
Local Institution - 0012
Local Institution - 0020
Local Institution - 0023
Local Institution - 0001
Local Institution - 0022
Local Institution
Local Institution - 0008
Local Institution - 0013
Local Institution - 0004
Local Institution - 0010
Local Institution - 0019
Local Institution - 0006


type: Other Identifier

title: A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

acronym: PODO

summary: The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.

status: Terminated

ReferenceCitation: Beck LH Jr, Berasi SP, Copley JB, Gorman D, Levy DI, Lim CN, Henderson JM, Salant DJ, Lu W. PODO: Trial Design: Phase 2 Study of PF-06730512 in Focal Segmental Glomerulosclerosis. Kidney Int Rep. 2021 Apr 3;6(6):1629-1633. doi: 10.1016/j.ekir.2021.03.892. eCollection 2021 Jun.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ipd_sharing: Yes

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

lead_sponsor: Pfizer

location_country:
Germany
Italy
Poland
Slovakia
United Kingdom
Japan
Mexico
United States
Spain
Czechia
Canada
France

location_facility: University of Alberta - Clinical Investigation Unit

location_facility: The Ohio State University Investigational Drug Services

location_facility: The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University of Alberta - Pharmacy Research Office

location_facility: The Cleveland Clinic - Investigational Drug Pharmacy

location_facility: Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB

location_facility: Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Baylor Scott & White Clinic - Temple South Loop

location_facility: University of Miami Katz Family Division of Nephrology

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

location_facility: CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont

location_facility: University of Cincinnati Gardner Neuroscience Institute

location_facility: Yale University School of Medicine - Yale-New Haven Hospital

location_facility: The Kirklin Clinic of University Alabama Birmingham Hospital

location_facility: Niigata University Medical & Dental Hospital

location_facility: Stanford Health Care Investigational Pharmacy

location_facility: Investigational Drug Service Pharmacy UAB Hosptial

location_facility: The Ohio State University Clinical Research Center

location_facility: University Hospitals Coventry & Warwickshire NHS Trust

location_facility: UCLA Clinical and Translational Research Center

location_facility: Universitätsklinikum Dresden, Medizinische Klinik III, Nephrologie

location_facility: St. George's University Hospitals NHS Foundation Trust

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: University of Miami Hospital and Clinics

location_facility: Vancouver General Hospital/Vancouver Coastal Health

location_facility: UAB Nephrology Research Clinic at Paula Building

location_facility: University of Cincinnati at DCI McMillan Research Unit

location_facility: CarePoint East at The Ohio State University

location_facility: Yale Center for Clinical Investigation Hospital Research Unit

location_facility: St. Paul's Hospital/Providence Health Care

location_facility: Hospital Universitario "Dr Jose Eleuterio Gonzalez"

location_facility: University of Iowa Hospitals and Clinics

location_facility: New York University Grossman School of Medicine - CTSI

location_facility: Boston Medical Center - Interventional Radiology

location_facility: UNC Clinical and Translational Research Center

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Yale Center for Clinical Investigation - Church Street Research Unit

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Yale Nephrology Clinical Research Clinic

status_simplified: Unknown


lead_sponsor: Regeneron Pharmaceuticals

summary: The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

title: A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

location_country:
Germany
Poland
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Taiwan
France


lead_sponsor: Enanta Pharmaceuticals, Inc

summary: A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis

ReferenceCitation: Ratziu V, Rinella ME, Neuschwander-Tetri BA, Lawitz E, Denham D, Kayali Z, Sheikh A, Kowdley KV, Desta T, Elkhashab M, DeGrauw J, Goodwin B, Ahmad A, Adda N. EDP-305 in patients with NASH: A phase II double-blind placebo-controlled dose-ranging study. J Hepatol. 2022 Mar;76(3):506-517. doi: 10.1016/j.jhep.2021.10.018. Epub 2021 Nov 3.

sponsor_collaborators:
Enanta Pharmaceuticals, Inc
ICON Clinical Research
Triangle Biostatistics

location_facility: CHU de Strasbourg - Nouvel Hôspital Civil

location_facility: Jacksonville Center for Endoscopy - Southside ; Borland Groover Clinic

location_facility: Wasatch Peak Family Practice/Radiant Research, Inc

location_facility: Carolinas Center for Liver Disease / Carolinas Health Care System

location_facility: Carolinas Medical Center Transplant Center/Center for Liver Disease

location_facility: University Of Tennessee Health Science Center

location_facility: Jacksonville Center for Clinical Research

location_facility: Mayo Clinic Health System - Franciscan Healthcare

location_facility: UCSD Altman Clinical and Translational Research Institute

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: CHU de Bordeaux - GH Sud - Hoital Haut Leveque

location_facility: Fleming Island Center for Clinical Research

location_facility: Clinical Research Advantage, Inc. / Colorado Springs Family Practice

location_facility: Addenbrookes Hospital (AH)-Cambridge University Hospitals NHS Foundation Trust

location_facility: Swedish Medical Center-Swedish Organ Transplant and Liver Center

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc

location_facility: University of Pittsburgh Medical Center - Center for Liver Diseases

location_facility: University of Washington / Harborview Medical Center

location_facility: Chronic Viral Illness Service McGill University Health Center/Royal Victoria

location_facility: WestGlen Gastrointestinal Consultants, PA

location_facility: NYU Langone Medical Center - The Center for Musculoskeletal Care (CMC)

location_facility: Southern California Transplantation Institute Research Foundation

location_facility: Research Associates of South Florida, LLC

location_facility: Feinberg School of Medicine Northwestern University

location_facility: Advanced Gastroenterology Associates, LLC

title: A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

location_country:
New Zealand
United Kingdom
United States
Canada
Puerto Rico
France


lead_sponsor: Genzyme, a Sanofi Company

summary:
Primary Objective:

-To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by the frequency of bleeding episodes.

Secondary Objectives:

To evaluate the efficacy of fitusiran compared to on-demand treatment with factor concentrates, as determined by:

The frequency of spontaneous bleeding episodes.
The frequency of joint bleeding episodes.
Health-related quality of life (HRQOL) in participants >=17 years of age.
To determine the frequency of bleeding episodes during the onset period.
To determine the safety and tolerability of fitusiran.

ReferenceCitation: Del Pozo Martin Y. 2021 ASH annual meeting. Lancet Haematol. 2022 Feb;9(2):e92-e93. doi: 10.1016/S2352-3026(21)00384-7. Epub 2021 Dec 16. No abstract available.

location_facility:
Investigational Site Number 2701
Investigational Site Number 103
Investigational Site Number 9108
Investigational Site Number 9106
Investigational Site Number 8601
Investigational Site Number 9005
Investigational Site Number 8104
Investigational Site Number 8807
Investigational Site Number 8204
Investigational Site Number 3602
Investigational Site Number 0140
Investigational Site Number 8202
Investigational Site Number 3904
Investigational Site Number 6101
Investigational Site Number 102
Investigational Site Number 8801
Investigational Site Number 4407
Investigational Site Number 9109
Investigational Site Number 8201
Investigational Site Number 8605
Investigational Site Number 4905
Investigational Site Number 4402
Investigational Site Number 111
Investigational Site Number 110
Investigational Site Number 8602
Investigational Site Number 9103
Investigational Site Number 9006
Investigational Site Number 8805
Investigational Site Number 8001
Investigational Site Number 8002
Investigational Site Number 9102
Investigational Site Number 9004
Investigational Site Number 9111
Investigational Site Number 3402
Investigational Site Number 8105
Investigational Site Number 3301
Investigational Site Number 6003
Investigational Site Number 8804
Investigational Site Number 119
Investigational Site Number 9104
Investigational Site Number 2702
Investigational Site Number 4906
Investigational Site Number 6103
Investigational Site Number 9003
Investigational Site Number 8808
Investigational Site Number 8005
Investigational Site Number 4401
Investigational Site Number 6002
Investigational Site Number 3305
Investigational Site Number 4501
Investigational Site Number 6004
Investigational Site Number 125
Investigational Site Number 9008
Investigational Site Number 9002
Investigational Site Number 9105
Investigational Site Number 9009
Investigational Site Number 8003
Investigational Site Number 8604
Investigational Site Number 8603
Investigational Site Number 128
Investigational Site Number 3303
Investigational Site Number 6104
Investigational Site Number 4904
Investigational Site Number 9701

title: ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX

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

location_country:
Germany
Australia
Japan
Turkey
France
Hungary
Denmark
United States
Ukraine
India
China
Malaysia
Italy
United Kingdom
Korea, Republic of
Spain
South Africa
Taiwan
Israel


summary:
The primary objectives of the study are:

To evaluate the long-term safety and tolerability of evinacumab in patients with Homozygous Familial Hypercholesterolemia (HoFH)
To evaluate the long-term safety and tolerability of evinacumab in adolescent patients with HoFH

The secondary objectives of the study are:

To evaluate the effect of evinacumab on lipid parameters in patients with HoFH
To evaluate the effect of evinacumab on lipid parameters in adolescent patients with HoFH
To evaluate the potential development of anti-evinacumab antibodies

location_facility:
Clinical Trial Site
Regeneron Study Site
Clinical Trial Site #2
Rgeneron Study Site
Clinical Trial Site #1

title: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

location_country:
Italy
Australia
Japan
Netherlands
Austria
United States
Greece
South Africa
Czechia
Canada
Ukraine
France


title: A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects With Autosomal Recessive Stargardt Disease

summary: To evaluate the safety and efficacy of Zimura™ (complement factor C5 inhibitor) compared to Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1).

lead_sponsor: IVERIC bio, Inc.

location_country:
Germany
France
Italy
Hungary
United Kingdom
United States
Spain
Israel

location_facility: Centre ophtalmologique des Quinzes Vingts

location_facility: Creteil University Eye Clinic University Paris EST

location_facility: Casey Eye Institute/Oregon Health & Science University

location_facility: Fondazione Policlinico Tor Vergata, UOSD Patologie Retiniche

location_facility: University of Campania Luigi Vanvitelli Eye Clinic

location_facility: University of Debrecen DE KK Szemészeti Klinika

location_facility: Tel-Aviv Sourasky Medical Center, Ichilov Hospital

location_facility: AOU Policlinico Sant'Orsola Malpighi, U.O. Oftalmologia,

location_facility: Jules Stein Eye Institute/ David Geffen School of Medicine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szemeszeti Klinika

location_facility: University of Michigan/Kellogg Eye Center

location_facility: University of Utah John A. Moran Eye Center


lead_sponsor: GE Healthcare

summary: This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

ReferenceCitation: Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31.

publisher_dissemination: Springer-Nature

sponsor_collaborators:
GE Healthcare
Pharmaceutical Product Development, LLC

location_facility: Center Hospitalier Universitaire de Sherbrooke CHUS

location_facility: Vascular Biology and Hypertension Program, University of Alabama at Birmingham

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

location_facility: Cardiology Physicians PA/Red Clay Research LLC

location_facility: VA Greater Los Angeles Health Care System

location_facility: Washington University School of Medicine

location_facility: VA North Texas Health Care System - NAVREF - PPDS

location_facility: Memorial City and Katy Cardiology Associates

location_facility: The Methodist Hospital Research Institute

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: University of Texas Southwestern Medical Center

location_facility: University Of Iowa Hospitals And Clinics

title: A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

primary_purpose: Diagnostic

location_country:
Germany
Finland
Netherlands
Switzerland
United States
Canada
France


title: A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies

acronym: INVICTUS

summary: This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo

ReferenceCitation: Symcox M, Somaiah N. Ripretinib for advanced gastrointestinal stromal tumor: Plain language summary of the INVICTUS study. Future Oncol. 2021 Dec 1;17(36):5007-5012. doi: 10.2217/fon-2021-0803. Epub 2021 Oct 18.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nd

license_normalized: cc-by-nd

publisher_dissemination: Future Science Ltd

ReferenceCitation: Blay JY, Serrano C, Heinrich MC, Zalcberg J, Bauer S, Gelderblom H, Schoffski P, Jones RL, Attia S, D'Amato G, Chi P, Reichardt P, Meade J, Shi K, Ruiz-Soto R, George S, von Mehren M. Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jul;21(7):923-934. doi: 10.1016/S1470-2045(20)30168-6. Epub 2020 Jun 5. Erratum In: Lancet Oncol. 2020 Jul;21(7):e341.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

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

lead_sponsor: Deciphera Pharmaceuticals LLC

location_country:
Finland
Germany
Italy
Poland
United Kingdom
Singapore
Australia
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Maria Sklodowska-Curie Memorial Cancer Center

location_facility: Hospitalario Universitario Virgen del Rocío

location_facility: University of Southern California - Norris


title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

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

location_facility: Winship Cancer Insitute, Emory Crawford Long Hospital

location_facility: Cancer Care - Torrance Memorial Physician Network

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Monter Cancer Center - Center for Advanced Medicine Location

location_facility: The University of Texas MD Anderson Cancer Center-merge

location_facility: Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital


title: A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

summary: The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.

ReferenceType: result

ReferenceCitation: Alexander Röth, Wilma Barcellini, Shirley D'Sa, Yoshitaka Miyakawa, Catherine M Broome, Marc Michel, David J. Kuter, Bernd Jilma, Tor Henrik Anderson Tvedt, Stella Lin, Xiaoyu Jiang, Caroline Reuter, William Hobbs, Sigbjørn Berentsen; Inhibition of Complement C1s with Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Results from the Phase 3 Cardinal Study. Blood 2019; 134 (Supplement_2): LBA-2. doi: https://doi.org/10.1182/blood-2019-132490

ReferenceCitation: Roth A, Barcellini W, Tvedt THA, Miyakawa Y, Kuter DJ, Su J, Jiang X, Hobbs W, Arias JM, Shafer F, Weitz IC. Sutimlimab improves quality of life in patients with cold agglutinin disease: results of patient-reported outcomes from the CARDINAL study. Ann Hematol. 2022 Oct;101(10):2169-2177. doi: 10.1007/s00277-022-04948-y. Epub 2022 Aug 23.

ReferenceCitation: Tvedt THA, Steien E, Ovrebo B, Haaverstad R, Hobbs W, Wardecki M, Tjonnfjord GE, Berentsen SA. Sutimlimab, an investigational C1s inhibitor, effectively prevents exacerbation of hemolytic anemia in a patient with cold agglutinin disease undergoing major surgery. Am J Hematol. 2022 Feb 1;97(2):E51-E54. doi: 10.1002/ajh.26409. Epub 2021 Dec 11. No abstract available.

evidence: open (via free article)

unpaywall_oa_status: bronze

ReferenceCitation: Roth A, Barcellini W, D'Sa S, Miyakawa Y, Broome CM, Michel M, Kuter DJ, Jilma B, Tvedt THA, Fruebis J, Jiang X, Lin S, Reuter C, Morales-Arias J, Hobbs W, Berentsen S. Sutimlimab in Cold Agglutinin Disease. N Engl J Med. 2021 Apr 8;384(14):1323-1334. doi: 10.1056/NEJMoa2027760.

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Bioverativ, a Sanofi company

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

location_facility: St Olavs Hospital, Avdeling for blodsykdommer

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Univ Ulm, Inst Klin. Transfusions. Immungen

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: U.O.C. Ematologia- Policlinico "A. Gemelli"

location_facility: Hospital Clinci i Provincial de Barcelona

location_facility: New York Medical College at Westchester Medical Center

location_facility: Hospital of the University of Pennsylvania


acronym: U-EXCEL

lead_sponsor: AbbVie

summary: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 166971

location_facility: Nara Medical University Hospital /ID# 169219

location_facility: AGA Clinical Research Associates, LLC /ID# 164769

location_facility: Japanese Red Cross Wakayama Medical Center /ID# 200643

location_facility: Southern California Res. Ctr. /ID# 169655

location_facility: Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908

location_facility: Immanuel Kant Baltic Federal University /ID# 203811

location_facility: Inje University Haeundae Hospital /ID# 202630

location_facility: King's College Hospital NHS Foundation Trust /ID# 169072

location_facility: General Hospital of Thessaloniki Hippokrateio /ID# 208825

location_facility: CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 222110

location_facility: Soroka University Medical Center /ID# 169913

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 168183

location_facility: Mustafa Kemal University Medic /ID# 171336

location_facility: Encore Borland-Groover Clinical Research /Id# 203499

location_facility: Carl R. Meisner Medical Clinic /ID# 201061

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 206154

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207466

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 204081

location_facility: Hoag Memorial Hosp Presbyterian /ID# 222540

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 171401

location_facility: Hiroshima University Hospital /ID# 166014

location_facility: Hadassah Medical Center-Hebrew University /ID# 169928

location_facility: Indianapolis Gastroenterology /ID# 164938

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773

location_facility: Citrus Valley Gastroenterology /ID# 166173

location_facility: Klinicki bolnicki centar Zagreb /ID# 171203

location_facility: Chung-Ang University Hostipal /ID# 207018

location_facility: Wakayama Medical University Hospital /ID# 169482

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 164927

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 167121

location_facility: Clinical Research of West Florida, Inc /ID# 208118

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904

location_facility: Duplicate_Care Access Research /ID# 164794

location_facility: Tokyo Women's Medical University Hospital /ID# 205980

location_facility: China Medical University Hospital /ID# 169791

location_facility: Southern Star Research Institute, LLC /ID# 169755

location_facility: South Eastern Health and Social Care Trust /ID# 205323

location_facility: Hospital Universitario y Politecnico La Fe /ID# 201992

location_facility: Hospital Universitario de Navarra /ID# 202355

location_facility: Advanced Research - Coral Springs /ID# 218021

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245

location_facility: Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842

location_facility: Richmond University Medical Center /ID# 201857

location_facility: Tel Aviv Sourasky Medical Center /ID# 204877

location_facility: Clinical Center University of Sarajevo /ID# 203887

location_facility: The Jikei University Hospital /ID# 167130

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 204088

location_facility: Tokai University Hachioji Hospital /ID# 165967

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 217962

location_facility: Scott Shulman Medicine Professional Corporation /ID# 169066

location_facility: Montefiore Medical Center - Moses Campus /ID# 166193

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564

location_facility: Hospital Clinico Universitario de Valencia /ID# 209657

location_facility: TX Clinical Research Institute /ID# 164896

location_facility: Assaf Harofeh Medical Center /ID# 204872

location_facility: Ottawa Hospital Research Institute /ID# 212414

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990

location_facility: Virginia Mason Medical Center /ID# 164913

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741

location_facility: Hospital Universitari Son Espases /ID# 201998

location_facility: Pauls Stradins Clinical University Hospital /ID# 169519

location_facility: University Clinical Center Tuzla /ID# 210325

location_facility: Johns Hopkins University School of Medicine /ID# 211941

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 168750

location_facility: Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 170120

location_facility: The Dudley Group NHS Foundation Trust /ID# 169069

location_facility: HonorHealth Research Institute - Shea /ID# 164821

location_facility: Kazan State Medical University /ID# 169638

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 206936

location_facility: Plains Clinical Research Center, LLC /ID# 170140

location_facility: Osaka Medical and Pharmaceutical University Hospital /ID# 206326

location_facility: Inselspital, Universitätsspital Bern /ID# 170997

location_facility: Hospital Italiano de Buenos Aires /ID# 215541

location_facility: Inonu Universitesi Turgut Ozal /ID# 201268

location_facility: Istanbul University Istanbul Medical Faculty /ID# 171364

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073

location_facility: Shiga University of Medical Science Hospital /ID# 167129

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 164771

location_facility: Omega Research Maitland, LLC /ID# 203481

location_facility: The First Affiliated Hospital, Sun Yat-sen University /ID# 205228

location_facility: GIRI Gastrointestinal Research Institute /ID# 166975

location_facility: The Royal Wolverhampton NHS Trust /ID# 171382

location_facility: Allegiance Research Specialists /ID# 165346

location_facility: Ctr for Advanced Gastroenterol /ID# 165353

location_facility: Treasure Valley Medical Research /ID# 215032

location_facility: Kaiser Clinica e Hospital Dia /ID# 166865

location_facility: Hospital de Clinicas de Porto Alegre /ID# 166862

location_facility: Zhongshan Hospital Xiamen University /ID# 204984

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645

location_facility: United Medical Doctors - Murrieta /ID# 164945

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 165478

location_facility: Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972

location_facility: Great Lakes Medical Research, LLC /ID# 202010

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010

location_facility: Centex Studies, Inc. - Houston /ID# 201214

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 168184

location_facility: East Tennessee Research Institute /ID# 203613

location_facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 209086

location_facility: Obudai Egeszsegugyi Centrum Kft. /ID# 201892

location_facility: East View Medical Research, LLC /ID# 171176

location_facility: Sapporo Medical University Hospital /ID# 167124

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 200214

location_facility: Air Force Specialized Hospital /ID# 170996

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 203494

location_facility: The First Affiliated Hospital of Nanchang University /ID# 204092

location_facility: Columbia Univ Medical Center /ID# 164782

location_facility: Malopolskie Centrum Kliniczne /ID# 202167

location_facility: Concord Repatriation General Hospital /ID# 171512

location_facility: Republican hospital named after V.A. Baranov /ID# 206488

location_facility: Clinical Research of West Florida, Inc /ID# 205827

location_facility: Taichung Veterans General Hospital /ID# 169790

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 201723

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935

location_facility: Hospital Universitario La Paz /ID# 201994

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762

location_facility: National Hepatology and Tropical Medicine Research Institute /ID# 170989

location_facility: National Hospital Organization Hirosaki General Medical Center /ID# 165961

location_facility: Agaplesion Markus Krankenhaus /ID# 168758

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 214470

location_facility: University Clinical Center Kragujevac /ID# 205859

location_facility: Hometown Urgent Care and Resea /ID# 201291

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091

location_facility: City Clinical Hospital No. 31 /ID# 208868

location_facility: Hospital Universitario Virgen Macarena /ID# 201993

location_facility: Osaka Metropolitan University Hospital /ID# 166015

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547

location_facility: West Tallinn Central Hospital /ID# 202785

location_facility: Vanderbilt University Medical Center /ID# 164946

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 168188

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 164947

location_facility: Delsol Research Management, Ll /Id# 170145

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012

location_facility: Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont /ID# 201724

location_facility: Cleveland Clinic Main Campus /ID# 209231

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579

location_facility: Pusan National University Hospital /ID# 167589

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607

location_facility: The First Hospital of Jilin University /ID# 206868

location_facility: Wake Forest Baptist Medical Center /ID# 164908

location_facility: Aichi Medical University Hospital /ID# 165971

location_facility: Universitatsklinikum Mannheim /ID# 168759

location_facility: National Hospital Organization Takasaki General Medical Center /ID# 167127

location_facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383

location_facility: Vilnius University Hospital Santaros Klinikos /ID# 203286

location_facility: The Sixth Affiliated Hosp Sun /ID# 204077

location_facility: Duplicate_Sjaellands Universitets Hospital /ID# 209445

location_facility: Gastoenterology Group of Rochester /ID# 166177

location_facility: The Second Xiangya Hospital of Central South University /ID# 204082

location_facility: Lahey Hospital and Medical Center /ID# 214726

location_facility: Gastroenterology Consultants PC - Roswell /ID# 218220

location_facility: Universitaetsklinikum Halle (Saale) /ID# 207455

location_facility: Rush University Medical Center /ID# 165497

location_facility: Clinical Hosp Center Zvezdara /ID# 168214

location_facility: Cabinet Particular Policlinic Algomed /ID# 167818

location_facility: CHA University Bundang Medical Center /ID# 167592

location_facility: Yonsei University Health System Severance Hospital /ID# 167590

location_facility: CliniCore International, LLC /ID# 164902

location_facility: Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 204076

location_facility: Coral Sea Clinical Research institute /ID# 212988

location_facility: Kanazawa University Hospital /ID# 169218

location_facility: Hospital Garcia de Orta, EPE /ID# 170241

location_facility: Digestive Disease Center Gastro /ID# 169508

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 164786

location_facility: Toyohashi Municipal Hospital /ID# 200175

location_facility: Advanced Research Institute, Inc /ID# 164921

location_facility: Universitaetsklinikum Frankfurt /ID# 203566

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943

location_facility: Rapid City Medical Center - GI Research /ID# 201735

location_facility: Radboud Universitair Medisch Centrum /ID# 166928

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 169070

location_facility: United Health Services Hospitals, Inc /ID# 217485

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 206994

location_facility: Fukuoka University Chikushi Hospital /ID# 214404

location_facility: General Hospital of Athens Ippokratio /ID# 167045

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 165343

location_facility: Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958

location_facility: Hyogo College of Medicine College Hospital /Id# 165973

location_facility: Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738

location_facility: Yokkaichi Hazu Medical Center /ID# 167196

location_facility: Sisli Etfal Train & Res Hosp /ID# 171334

location_facility: Lenasia Clinical Trial Centre /ID# 205145

location_facility: Hayang University GuriHospital /ID# 167587

location_facility: Nagoya City University Hospital /ID# 165970

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 168189

location_facility: Iwate Medical University Uchimaru Medical Center /ID# 202464

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 168187

location_facility: Clinical Research Trials of Florida, Inc. /ID# 203485

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 216419

location_facility: Policlinico San Martino/Univer /ID# 168191

location_facility: University of Iowa Hospitals and Clinics /ID# 165436

location_facility: Texas Digestive Disease Consultants /ID# 209801

location_facility: Tyler Research Institute, LLC /ID# 168687

location_facility: Gastroenterologie am Mexikoplatz /ID# 203575

location_facility: Sahlgrenska University Hospital /ID# 169171

location_facility: Tzaneio general hospital of Piraeus /ID# 206433

location_facility: MediSphere Medical Research Center /ID# 166175

location_facility: Gazi Universitesi Tip Fakultes /ID# 217444

location_facility: Atlanta Gastroenterology Spec /ID# 164799

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 168044

location_facility: Private Practice Dr MN Rajabally /ID# 169853

location_facility: South Edmonton Gastroenterology Research Clinic /ID# 166978

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 168190

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248

location_facility: Hospital Universitario San Vic /ID# 200029

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104

location_facility: CB Flock Research Corporation /ID# 166185

location_facility: Hospital Privado Univesitario /ID# 169230

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 170119

location_facility: Hospital Provincial del Centenario /ID# 171252

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212423

location_facility: Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 205535

location_facility: Karolinska University Hospital Solna /ID# 224488

location_facility: University of Chicago Medicine /ID# 165503

location_facility: Hospital Clinic de Barcelona /ID# 201990

location_facility: Crystal Pharmacology Research /ID# 166081

location_facility: Velocity Clinical Research - Salt Lake City /ID# 166076

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 201897

location_facility: Kyungpook National University Hospital /ID# 207019

location_facility: QEII - Health Sciences Centre /ID# 169307

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425

location_facility: Hospital Nossa Senhora das Graças /ID# 166863

location_facility: Erciyes University Medical Fac /ID# 171331

location_facility: Clin Res Inst of Michigan, LLC /ID# 170133

location_facility: MNI KRC Kyiv Regional Clinical Hospital /ID# 202454

location_facility: Universitaetsklinikum Erlangen /ID# 203552

location_facility: Medical Research Center of CT /ID# 164926

location_facility: Atrium Health Carolinas Medical Center /ID# 164932

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144

location_facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997

location_facility: Asahikawa Medical University Hospital /ID# 167120

location_facility: University Clinical Center Serbia /ID# 168215

location_facility: The Vancouver Clinic, INC. PS /ID# 164918

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Cisanello /ID# 202421

location_facility: Toyama Prefectural Central Hospital /ID# 217834

location_facility: Hospital Universitario de Salamanca /ID# 206358

location_facility: Texas Digestive Disease Consultants /ID# 209953

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208051

location_facility: Peak Gastroenterology Associates, PC /ID# 170143

location_facility: Niigata University Medical & Dental Hospital /ID# 170045

location_facility: P.A. Bayandin Murmansk Regiona /ID# 169639

location_facility: Healthcare Research Consultant /ID# 166195

location_facility: Digestive Disease Specialists /ID# 201064

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075

location_facility: Faculdade de Medicina do ABC /ID# 208323

location_facility: Toho University Sakura Medical Center /ID# 165963

location_facility: Nemocnice Ceske Budejovice a.s. /ID# 224389

location_facility: Nanfang Hospital of Southern Medical University /ID# 204083

location_facility: London Health Sciences Center /ID# 221038

location_facility: Mentahaz Maganorvosi Kozpont /ID# 201895

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 224301

location_facility: Univ of California San Francis /ID# 164944

location_facility: Quality Clinical Research Inc. /ID# 170137

location_facility: Louisana Research Center, LLC /ID# 164894

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 203910

location_facility: CISSS de Chaudière-Appalaches, Hôpital Hotel-Dieu de Lévis /ID# 166969

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332

location_facility: Hamamatsu University Hospital /ID# 224352

location_facility: Stockport NHS foundation trust /ID# 208719

location_facility: Toronto Digestive Disease Asso /ID# 166972

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181

location_facility: National Taiwan University Hospital /ID# 169792

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 205552

location_facility: Taunton and Somerset NHS Foundation Trust /ID# 209665

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 170849

location_facility: Options Health Research, LLC /ID# 164820

location_facility: CHU Grenoble - Hopital Michallon /ID# 219034

location_facility: Caprock Gastro Research, LLC /ID# 215438

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013

location_facility: Yokohama City University Medical Center /ID# 167128

location_facility: Yamagata University Hospital /ID# 200157

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 207889

location_facility: Gastro Health & Nutrition - Victoria /ID# 167812

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 167044

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182

location_facility: Dayton Gastroenterology, Inc. /ID# 167627

location_facility: Medizinische Universitaet Wien /ID# 169465

location_facility: Digestive Health Associates (DHA) - Farmington Hills /ID# 205793

location_facility: Tokyo Medical And Dental University Hospital /ID# 165965

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

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

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Bosnia and Herzegovina
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
China
Malaysia
Estonia
Puerto Rico
Egypt
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

acronym: HARBOUR

summary: The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL.

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

lead_sponsor: Amgen

sponsor_collaborators:
Amgen
Merck Sharp & Dohme LLC

location_country:
Germany
Australia
Netherlands
United States
Spain
France


title: Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir Versus Standard of Care for Treatment of Adenovirus in High-risk Pediatric Allogeneic Hematopoietic Transplant Recipients

acronym: AdAPT

summary: This study was designed to assess the safety, overall tolerability, and antiviral activity of "short course" brincidofovir (BCV) therapy, as compared with current standard of care (SoC), for the treatment of adenovirus (AdV) infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant (HCT) recipients. A virologic response-driven approach to the duration of treatment was to be evaluated, in which subjects randomized to BCV therapy were to be treated until AdV viremia was confirmed as undetectable or until a maximum of 16 weeks of therapy, whichever occurred first. The formulation of BCV used in this study was oral tablet/suspension.

lead_sponsor: Chimerix

location_country:
Ireland
Italy
Germany
Poland
United Kingdom
Netherlands
United States
Spain
France

location_facility: University of Washington-Seattle Childrens Hospital

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Joseph M. Sanzari Childrens Hospital-Regional Cancer Care

location_facility: Charite Universitatsmedizin Berlin, Campus Virchow-Klinikum

location_facility: IHOPe-Institut d'Homatologie et d'Oncologie Pediatrique

location_facility: Universitatsklinik fur Kinder-und Jugendmedizin

location_facility: Great Ormond Street Hospital for Children

location_facility: Newcastle-upon-Tyne Hospitals-Great Childrens Hospital

location_facility: Uniwerstytecki Azpital Kliniczny we Wroclawiu

location_facility: Dr. von Haunersches Kinderspital, Abteilung fur Padiatrische

location_facility: Cincinnati Childrens Hospital Medical Center


title: A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

acronym: DIAMOND-AF

summary: The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

ReferenceType: background

ReferenceCitation: Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.

ReferenceCitation: Kautzner J, Albenque JP, Natale A, Maddox W, Cuoco F, Neuzil P, Poty H, Getman MK, Liu S, Starek Z, Dukkipati SR, Colley BJ 3rd, Al-Ahmad A, Sidney DS, McElderry HT. A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Mar;7(3):352-363. doi: 10.1016/j.jacep.2020.11.009. Epub 2021 Jan 27.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
United States
Czechia
Canada
France

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Institut Klinicke a Experimentalni Mediciny (IKEM)

intervention_type: Device


summary: The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Dermatovenerologicka klinika 3. LF UK a FNKV

location_facility: Dermatovenerologicka klinika VFN a 1. LF UK

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Azienda Ospedaliera Universitaria Senese

title: A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated

location_country:
Germany
Ireland
Italy
Poland
New Zealand
United Kingdom
Australia
Japan
Netherlands
Switzerland
United States
Spain
Greece
Czechia
Canada
France


title: A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Adults With Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, or Allogeneic Hematopoietic Cell Transplant Recipients

summary: The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.

lead_sponsor: Vical

location_country:
Germany
Belgium
United States
Korea, Republic of
Canada
France

location_facility: UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases

location_facility: General Hospital Saint-Jan, Department of Hematology

location_facility: Washington University School of Medicine, Division of Infectious Disease

location_facility: Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology

location_facility: University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology

location_facility: Christiana Care Health Services, Department of Medicine

location_facility: University Hospital Antwerp (UZA), Department of Hematology

location_facility: UCL Mont-Godinne University Hospitals, Department of Hematology

location_facility: Medical College of Georgia at Augusta University

location_facility: Hamilton Health Sciences, Infectious Disease Research

location_facility: Jules Bordet Institute, Department of Infectious Disease

location_facility: University of Alabama at Birmingham Hospital, Division of Infectious Diseases

location_facility: McGill University Health Centre (MUHC), Division of Infectios Diseases

location_facility: The University of Texas Health Science Center, Department of Internal Medicine

location_facility: Grenoble University Hospital Center, Department of Hematology

location_facility: Fred Hutchinson Cancer Research Center (FHCRC)

location_facility: University of Minnesota, Department of Medicine


title: GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

summary: The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).

lead_sponsor: Incyte Corporation

location_country:
United States
Italy
Spain
France

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Winship Cancer Institute of Emory University

location_facility: Washington University School of Medicine

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Anschutz Cancer Pavilion - University of Colorado

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Azienda Ospedaliera San Gerardo Di Monza

location_facility: John Theurer Cancer Center, Hackensack University Medical Center

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Chu Vandoeuvre-Les-Nancy, Hopital Brabois


acronym: POLYP 2

summary:
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments.

Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.

ReferenceCitation: Damask C, Chen M, Holweg CTJ, Yoo B, Millette LA, Franzese C. Defining the Efficacy of Omalizumab in Nasal Polyposis: A POLYP 1 and POLYP 2 Subgroup Analysis. Am J Rhinol Allergy. 2022 Jan;36(1):135-141. doi: 10.1177/19458924211030486. Epub 2021 Aug 12.

publisher_dissemination: SAGE Publications

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.

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

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

repository_institution: University of East Anglia - UEA Digital Repository

ReferenceCitation: Peters AT, Han JK, Hellings P, Heffler E, Gevaert P, Bachert C, Xu Y, Chuang CC, Neupane B, Msihid J, Mannent LP, Guyot P, Kamat S. Indirect Treatment Comparison of Biologics in Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2021 Jun;9(6):2461-2471.e5. doi: 10.1016/j.jaip.2021.01.031. Epub 2021 Feb 4.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven);archive.ugent.be

location_facility: Nouvel Hopital Civil; Pole de Pathologie Thoracique

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Municipal Institution "City Clinical Hospital #3"

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: CHUS - H. Clinico U. de Santiago; Servicio de Otorrinonaringologia

location_facility: Kaiser Permanente - Rancho Cordova Medical Offices

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

location_facility: SI Institute of Otolaryngology n.a. Prof. O.S. Kolomiychenko

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: University of Missouri, ENT and Allergy Center of Missouri

location_facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: Banner University of Arizona Medical Center

location_facility: Central Clinical Hospital With Polyclinic of President Administration of RF

location_facility: Allergy Associates Research Center LLC - CRN

location_facility: Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak

title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Clinical Trial of Omalizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps

location_country:
Finland
Poland
Hungary
Mexico
Belgium
United States
Spain
Ukraine
Russian Federation
France


lead_sponsor: Pharmacyclics Switzerland GmbH

summary: Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

sponsor_collaborators: Janssen Biotech, Inc., including Johnson & Johnson

location_facility: Szpital Specjalistyczny w Brzozowie, Oddział Hematologii Onkologicznej z Klinicznym Oddziałem Przeszczepiania Szpiku

location_facility: Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency

location_facility: Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: CNE CCOHTPC of Cherkasy Regional Council

location_facility: SBI of Ryazan region "Regional Clinical Hospital"

location_facility: TRIO - Comprehensive Cancer Centers of Nevada

location_facility: University of Pennsylvania Abramson Cancer Center

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

location_facility: Azienda Sanitaria Universitaria Integrata Udine

location_facility: CNCE City Clinical Hospital 4 of Dnipro City Council

location_facility: Almazov National Medical Research Centre

location_facility: Hematology and Oncology Masaryk University Hospital Brno

location_facility: John Theurer Cancer Center, Hackensack UMC

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center

location_facility: Northwest Cancer Specialists, Compass Oncology

location_facility: Kyungpook National University Hospital (KNUH)

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: University College Hospitals NHS Foundation Trust

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center

location_facility: Concord Repatriation General Hospital - Haematology Clinical Trials

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of AMSU

location_facility: University of California Los Angeles (UCLA)

location_facility: Norton Medical Plaza II, 3991 Dutchmans Lane

status: Enrolling by invitation

title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

location_country:
Italy
Poland
New Zealand
Hungary
United Kingdom
Australia
Sweden
United States
Korea, Republic of
Spain
Turkey
Taiwan
Czechia
Canada
Ukraine
Russian Federation
France


title: A Phase 2 Study of Pembrolizumab in Combination With Daratumumab (Anti CD38) in Participants With Relapsed Refractory Multiple Myeloma (rrMM)

summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with daratumumab in participants with relapsed refractory multiple myeloma (rrMM). The primary outcome measure for this study is the assessment of Objective Response Rate (ORR) in participants with rrMM.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
France
Sweden
United States
Spain
Canada
Israel

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0106)

location_facility: Hospital Clinico Universitario de Salamanca ( Site 0300)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0303)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 0302)

location_facility: Karolinska Universitetssjukhuset ( Site 0501)

location_facility: Capital Health Queen Elizabeth II Health Sciences Centre ( Site 0101)

location_facility: Hospital Clinico Universitario de Valencia ( Site 0304)

location_facility: Emory University School of Medicine ( Site 0002)

location_facility: Clinica Universitaria de Navarra ( Site 0301)

location_facility: Hopital Maisonneuve-Rosemont [Montreal, Canada] ( Site 0102)

location_facility: Calgary Lab Services - Foothills Medical Centre ( Site 0105)

location_facility: McGill University Health Centre ( Site 0100)

location_facility: CHRU Lille Hospital Claude Huriez ( Site 0200)

location_facility: Skaenes Universitetssjukhus Lund ( Site 0500)

intervention_type: Biological


acronym: ALPINE 2

lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.

location_facility: Johns Hopkins All Children's Hospital Outpatient Care Center

location_facility: Hospital Regional Universitario de Malaga

location_facility: Royal Devon and Exeter Foundation NHS Trust

location_facility: University Hospitals of North Midlands NHS trust Royal Stoke University Hospital

location_facility: Kings College Hospital NHS foundation Trust

location_facility: Barts and the London Children's Hospital

location_facility: University of Mississippi Medical center

location_facility: Schneider Children's Medical Center of Israel

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: General Hospital of Thessaloniki,3rd Dept of Pediatrics

location_facility: Ann & Robert H Lurie Childrens Hospital of Chicago

location_facility: USC Department of Pediatrics/Division of Pediatric Pulmonology

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Hadassah University Hospital Mount Scopus

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: University of California San Francisco (UCSF) - Benioff Children's Hospital

location_facility: University Hospitals of Leicester NHS trust

location_facility: Southampton University Hospitals NHS trust, Southampton General Hospital

location_facility: Azienda Policlinico Umberto - Universita La Sapienza di Roma

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Hopital Universitaire des Enfants Reine Fabiola

title: Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

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


title: A Prospective International Multicenter Phase II Study to Evaluate the Efficacy, Safety and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Previous Therapy With Checkpoint Inhibitor Treatment

acronym: IO-PAZ

summary: The main purpose of this study was to assess the progression-free survival (PFS) based on local investigator assessment of pazopanib in participants with advanced and/or metastatic renal cell carcinoma (mRCC) following prior treatment with immune checkpoint inhibitors (ICI).

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Hungary
Argentina
United Kingdom
Austria
United States
Spain
Chile
Czechia
Canada
France

location_facility:
Roswell Park Cancer Institute
Novartis Investigative Site


acronym: SELECT-AXIS 1

summary: The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).

ReferenceCitation: van der Heijde D, Song IH, Pangan AL, Deodhar A, van den Bosch F, Maksymowych WP, Kim TH, Kishimoto M, Everding A, Sui Y, Wang X, Chu AD, Sieper J. Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis (SELECT-AXIS 1): a multicentre, randomised, double-blind, placebo-controlled, phase 2/3 trial. Lancet. 2019 Dec 7;394(10214):2108-2117. doi: 10.1016/S0140-6736(19)32534-6. Epub 2019 Nov 12.

ReferenceCitation: Deodhar A, van der Heijde D, Sieper J, Van den Bosch F, Maksymowych WP, Kim TH, Kishimoto M, Ostor A, Combe B, Sui Y, Chu AD, Song IH. Safety and Efficacy of Upadacitinib in Patients With Active Ankylosing Spondylitis and an Inadequate Response to Nonsteroidal Antiinflammatory Drug Therapy: One-Year Results of a Double-Blind, Placebo-Controlled Study and Open-Label Extension. Arthritis Rheumatol. 2022 Jan;74(1):70-80. doi: 10.1002/art.41911. Epub 2021 Nov 12.

repository_institution: Leiden University - Leiden Repository

repositories_institution: Ghent University - Ghent University Academic Bibliography

location_facility: Colorado Arthritis Associates /ID# 164444

location_facility: Diagnostic Group Integrated He /ID# 165195

location_facility: Bay Area Arthritis and Osteo /ID# 165023

location_facility: Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 165146

location_facility: Osaka City University Hospital /ID# 165253

location_facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 166202

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 166309

location_facility: Ospedale Sant Orsola Malpighi /ID# 165692

location_facility: Unidade Local De Saude Do Alto Minho /ID# 168310

location_facility: Revita Reumatologiai Rendelo /ID# 164724

location_facility: Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 164741

location_facility: National Hospital Organization Osaka Minami Medical Center /ID# 164365

location_facility: ETYKA-Osrodek Badan Klinicznyc /ID# 165634

location_facility: Instituto Portugues De Reumatologia /ID# 168314

location_facility: Chonnam National University Hospital /ID# 164541

location_facility: CHRU de Montpellier - Hôpital Lapeyronie /ID# 166308

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 165238

location_facility: Arth and Osteo Clin Brazo Valley /ID# 165194

location_facility: National Hospital Organization Asahikawa Medical Center /ID# 164566

location_facility: Royal National Hosp for Rheuma /ID# 165147

location_facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 165705

location_facility: Centro Hospitalar Lisboa Ocidental, EPE /ID# 168312

location_facility: Arizona Arthritis & Rheumatolo /ID# 164446

location_facility: Rheumatology Center of San Diego /ID# 166167

location_facility: Corporac Sanitaria Parc Tauli /ID# 165029

location_facility: Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 168107

location_facility: Hospital of the University of Occupational and Environmental Health /ID# 164380

location_facility: Hanyang University Seoul Hospi /ID# 165811

location_facility: Helsinki Univ Central Hospital /ID# 165794

location_facility: Clinical Investigation Specialists - Skokie /ID# 164385

location_facility: St.Luke's International Hospital /ID# 165219

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 165028

location_facility: Juntendo University Hospital /ID# 164738

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 164549

location_facility: Chungnam National University Hospital /ID# 164561

location_facility: Tokushima University Hospital /ID# 165108

location_facility: Saitama Medical University Hospital /ID# 164577

location_facility: CHRU Tours - Hopital Trousseau /ID# 165109

location_facility: Okayama Saiseikai Outpatient Center Hospital /ID# 165595

location_facility: Kyunghee University Hospital at Gangdong /ID# 164569

location_facility: Hospital Parc de Salut del Mar /ID# 165027

location_facility: Japanese Red Cross Okayama Hospital /ID# 164376

location_facility: Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 168313

location_facility: Gachon University Gil Medical Center /ID# 165114

location_facility: Universitair Medisch Centrum Groningen /ID# 165681

location_facility: Norfolk and Norwich Univ Hosp /ID# 165149

location_facility: Charite - Campus Benjamin Franklin Medizinische Klinik - Rheumatologie /ID# 165153

location_facility: Juntendo University Koshigaya Hospital /ID# 165809

location_facility: Kochi Medical School Hospital /ID# 164460

location_facility: University of Alberta - Division of Rheumatology /ID# 165239

location_facility: Clinical Research Ctr Reading /ID# 164876

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis

location_country:
Finland
Germany
Poland
New Zealand
Australia
Japan
Croatia
Czechia
Canada
France
Portugal
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Sweden


lead_sponsor: Castle Creek Pharmaceuticals, LLC

summary: Epidermolysis bullosa simplex (EBS) is a rare genetic skin disease characterized by fragility of the skin and mucous membranes resulting in painful blisters and erosions after minor trauma. The purpose of this study is to compare the efficacy of diacerein 1% ointment to vehicle ointment when applied once-daily for 8 weeks in subjects with EBS.

location_facility: CHU de NICE - Hopital de l'Archet II - Service de Dermatologie

location_facility: Children's Hospital of San Antonio ; Texas Dermatology and Laser Specialists

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: St. Thomas' Hospital - St Johns Institute of Dermatology

location_facility: Medical University of South Carolina (MUSC)

location_facility: University of North Carolina - Chapel Hill

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

title: An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects With Epidermolysis Bullosa Simplex

location_country:
Germany
Israel
United Kingdom
Australia
Netherlands
Austria
United States
France


acronym: RUBATO

lead_sponsor: Actelion

summary: The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.

location_facility: Wojewódzki Szpital Specjalistyczny We Wrocławiu

location_facility: Deutsches Herzzentrum Berlinklinik Für Angeborene Herzfehler

location_facility: The Prince Charles Hospital, Adult Congenital Heart Disease Unit

location_facility: Massachusetts General Hospital Heart Center

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Providence Medical Research Providence Health Care

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

title: Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects

location_country:
Germany
Poland
New Zealand
United Kingdom
Denmark
Australia
United States
China
Taiwan
Czechia
Canada
France


title: A Phase 1 Study of SY-1365, a Selective CDK7 Inhibitor, in Adult Patients With Advanced Solid Tumors

summary:
This study consists of two parts. Part 1 is a dose-escalation/safety evaluation to provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2.

Following the identification of a recommended dose and regimen from Part 1, the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors, and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology.

ReferenceCitation: Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8.

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

ipd_sharing: Undecided

lead_sponsor: Syros Pharmaceuticals

location_country:
United States
Canada
France

location_facility: Women and Infants Hospital of Rhode Island

location_facility: South Texas Accelerated Research Therapeutics

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: University of Texas Southwestern Medical Center


title: A Phase I Open Label Clinical Trial Evaluating the Safety and Anti-Tumor Activity of Autologous T Cells Expressing Enhanced TCRs Specific for Alpha Fetoprotein (AFPᶜ³³²T) in HLA-A2 Positive Subjects With Advanced Hepatocellular Carcinoma (HCC) or Other AFP Expressing Tumor Types

summary:
This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor. Those who did not tolerate or refused other therapies may also participate. The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein (AFP) and find out what effects, if any, they have in subjects with liver cancer or other AFP expressing tumor types. This study is for subjects who have a blood test positive for appropriate HLA-A*02 P Group and have adequate AFP protein in blood or tumor, and whose noncancerous liver tissue has very little AFP protein (Liver only).

The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.

The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion after 3 days of chemotherapy. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose.

Subjects will be hospitalized for at least 1 week after receiving their T cells back and then seen frequently by the Study Physician for the next 6 months. After that, subjects will be seen every three months. If subjects have disease progression or withdraw from the study, they will then be entered into a long-term follow up for safety monitoring. In long-term follow up, subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion and annually for the next 10 years.

lead_sponsor: Adaptimmune

location_country:
United States
Spain
United Kingdom
France

location_facility: Mayo Clinic Clinical Trial Referral Office

location_facility: Winship Cancer Institute - Emory University

location_facility: Washington University - School of Medicine

location_facility: University of Maryland, Greenebaum Cancer Center

intervention_type: Genetic


title: A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis

summary: The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.

ReferenceCitation: Braun J, Kiltz U, Deodhar A, Tomita T, Dougados M, Bolce R, Sandoval D, Lin CY, Walsh J. Efficacy and safety of ixekizumab treatment in patients with axial spondyloarthritis: 2-year results from COAST. RMD Open. 2022 Jul;8(2):e002165. doi: 10.1136/rmdopen-2021-002165.

publisher_dissemination: British Medical Journal

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:
Finland
Germany
Poland
Argentina
Japan
Brazil
Czechia
Canada
France
Hungary
United States
Romania
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centro de Enfermedades del Higado y Aparato Digestivo

location_facility: KH der Barmherzigen Schwestern Wien BetriebsGesmbH

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA

location_facility: Shanahan Rheumatology & Immunotherapy, PLLC

location_facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela

location_facility: Interni a revmatologicka ambulance, Inrea s.r.o.

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Kyunghee University Hospital at Gangdong

location_facility: Investigación y Biomedicina de Chihuahua, SC

location_facility: Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci

location_facility: Unidad de Investigacion en Enfermedades Cronico Degenerative

location_facility: Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

location_facility: CIR Centro de Investigacions Reumatologicas

location_facility: Univ of Texas Health Science Center - Houston

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC

location_facility: Arizona Arthritis & Rheumatology Research

location_facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Articularis Healthcare Group, INC dba Columbia Arthritis Ctr

location_facility: Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: Clinica en Investigación en Reumatologia y Obesidad S.C.


acronym: Asteroid

lead_sponsor: Ultragenyx Pharmaceutical Inc

summary: The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.

sponsor_collaborators:
Ultragenyx Pharmaceutical Inc
Mereo BioPharma

title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804)

location_country:
United Kingdom
Denmark
United States
Canada
France