title: A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins

summary: This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.

ReferenceCitation: Moriarty PM, Jacobson TA, Bruckert E, Thompson PD, Guyton JR, Baccara-Dinet MT, Gipe D. Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial. J Clin Lipidol. 2014 Nov-Dec;8(6):554-561. doi: 10.1016/j.jacl.2014.09.007. Epub 2014 Sep 19.

ReferenceCitation: Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, Bruckert E, Jacobson TA, Kopecky SL, Baccara-Dinet MT, Du Y, Pordy R, Gipe DA; ODYSSEY ALTERNATIVE Investigators. Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial. J Clin Lipidol. 2015 Nov-Dec;9(6):758-769. doi: 10.1016/j.jacl.2015.08.006. Epub 2015 Aug 29.

family: Moriarty

full_name: Patrick M. Moriarty

given: Patrick M.

family: Thompson

full_name: Paul D. Thompson

given: Paul D.

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

family: Guyton

full_name: John R. Guyton

given: John R.

family: Bergeron

full_name: Jean Bergeron

given: Jean

family: Zieve

full_name: Franklin J. Zieve

given: Franklin J.

family: Bruckert

full_name: Eric Bruckert

given: Eric

family: Jacobson

full_name: Terry A. Jacobson

given: Terry A.

family: Kopecky

full_name: Stephen L. Kopecky

given: Stephen L.

family: Baccara-Dinet

full_name: Marie T. Baccara-Dinet

given: Marie T.

family: Du

full_name: Yunling Du

given: Yunling

family: Pordy

full_name: Robert Pordy

given: Robert

family: Gipe

full_name: Daniel A. Gipe

given: Daniel A.

journal_name: Journal of Clinical Lipidology

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

repository_normalized: HAL

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

ReferenceCitation: Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, Bruckert E, Jacobson TA, Baccara-Dinet MT, Zhao J, Donahue S, Ali S, Manvelian G, Pordy R. Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial. J Clin Lipidol. 2020 Jan - Feb;14(1):88-97.e2. doi: 10.1016/j.jacl.2020.01.001. Epub 2020 Jan 13.

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

name: Li Ka Shing Knowledge Institute; St Michael's Hospital; University of Toronto; Toronto ON Canada

name: Department of Clinical Endocrinology and Nutrition (IBIMA); Hospital Virgen de la Victoria; University of Málaga; CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn); Instituto de Salud Carlos III; Málaga Spain

name: Sidney Kimmel Medical College; Thomas Jefferson University; Philadelphia PA USA

name: Biostatistics and Programming Department; Sanofi, Chilly-Mazarin France

name: Regeneron Pharmaceuticals, Inc.; Tarrytown NY USA

name: Baylor College of Medicine; Houston TX USA

ReferenceCitation: Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov - Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. Erratum in: J Clin Lipidol. 2020 Sep - Oct;14(5):742.

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. Epub 2016 Oct 24.

location_country:
Italy
Austria
France
Israel
Norway
United States
United Kingdom
Canada


type: EudraCT Number

title: PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

acronym: PSMAfore

summary:
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the rPFS or death compared to a change in ARDT in mCRPC participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings.

Approximately 450 participants will be randomized (225 per treatment group).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Austria
Sweden
Switzerland
Netherlands
France
Czechia
Poland
Slovakia
Belgium
Spain
United States
United Kingdom

location_facility: Dana-Farber Cancer Institute Dana-Farber Cancer Institute_

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Nebraska Cancer Specialists Oncology Hematology West

location_facility: Tulane University Health Sciences Center

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

summary: The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.

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

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
France
Czechia
Greece
Poland
Thailand
Hungary
New Zealand
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Szpital Kliniczny im. H. Swiecickiego w Poznaniu; Oddział Onkologii Klinicznej i Doswiadczalnej

location_facility: China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

location_facility: CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ŚW. JANA Z DUKLI; II Oddział Onkologii Klinicznej

location_facility: Washington University School of Medicine

location_facility: Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: Beskidzkie Centrum Onkologii- Szpital Miejski

location_facility: Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine

location_facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont; Onkoradiologiai Kozpont

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Periph. University General Hospital of Heraklion Crete; Oncology Department

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz; Onkoradiológia

location_facility: National Taiwan University Hospital; Oncology

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

intervention_type: Drug


title: A Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

summary: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

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

location_country:
Italy
United States
Brazil
Spain
Germany
France
Czechia
Greece
Israel
Japan
Poland
Ireland
Belgium
Argentina
Russian Federation
China
Canada
United Kingdom
Korea, Republic of
Ukraine

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Oncocentro Serviços Medicos E Hospitalares Ltda

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Hospital Alemao Oswaldo Cruz; Pesquisa Clinica

location_facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico

location_facility: AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica

location_facility: FSI Russian Centre of Radiology and Surgical Technologies

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: St-Petersburg Regional Oncology Dispensary; Oncology

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Universitätsklinikum Jena, Urologische Klinik und Poliklinik

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Saitama Medical University International Medical Center

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: St. Marianna University School of Medicine Hospital

location_facility: University College London NHS Foundation Trust

location_facility: Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

location_facility: Centre D'Oncologie de Gentilly; Oncology


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

lead_sponsor: UCB Biopharma SRL

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

source: euctr

title: A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease

summary: The purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of disease progression over 12 and 18 months in participants diagnosed with early-stage Parkinson's Disease.


type: Other Identifier

title: MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY

summary: The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

design_allocation: Non-Randomized

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:
United States
Germany
France
Japan
Poland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

location_facility: Indiana Blood and Marrow Transplantation-Clinic

location_facility: University of Iowa Hospitals and Clinics

location_facility: CHU de Quebec - Université Laval - Hotel Dieu de Quebec

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

location_facility: McGill University Health Centre - Glen Site

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy

location_facility: Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu

location_facility: Winship Cancer Institute @ Emory University Hospital Midtown

location_facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: UC Irvine Health - Chao Family Comprehensive Cancer Center

location_facility: Indiana Blood and Marrow Transplantation-Administrative Offices

location_facility: Winship Cancer Institute, Emory University

location_facility: CHU de Poitiers, Pôle Régional de Cancérologie

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

location_facility: Loyola University Chicago performing research at Loyola University Medical Center

location_facility: Hospital Universitario Quironsalud Madrid

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

location_facility: Baylor University Medical Center, Baylor Scott & White

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: Ochsner Medical Center - Jefferson Highway

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: Barwon Health, University Hospital Geelong

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont


ReferenceType: derived

ReferenceCitation: Fust K, Maschio M, Kohli M, Singh S, Pritchard DM, Marteau F, Myrenfors P, Feuilly M. A Budget Impact Model of the Addition of Telotristat Ethyl Treatment to the Standard of Care in Patients with Uncontrolled Carcinoid Syndrome. Pharmacoeconomics. 2020 Jun;38(6):607-618. doi: 10.1007/s40273-020-00896-5.

family: Fust

full_name: Kelly Fust

given: Kelly

sequence: first

family: Maschio

full_name: Michael Maschio

given: Michael

sequence: additional

family: Kohli

full_name: Michele Kohli

given: Michele

family: Singh

full_name: Simron Singh

given: Simron

family: Pritchard

full_name: D. Mark Pritchard

given: D. Mark

family: Marteau

full_name: Florence Marteau

given: Florence

family: Myrenfors

full_name: Peter Myrenfors

given: Peter

family: Feuilly

full_name: Marion Feuilly

given: Marion

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PharmacoEconomics

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Dillon JS, Kulke MH, Hörsch D, Anthony LB, Warner RRP, Bergsland E, Welin S, O'Dorisio TM, Kunz PL, McKee C, Lapuerta P, Banks P, Pavel M. Time to Sustained Improvement in Bowel Movement Frequency with Telotristat Ethyl: Analyses of Phase III Studies in Carcinoid Syndrome. J Gastrointest Cancer. 2021 Mar;52(1):212-221. doi: 10.1007/s12029-020-00375-2.

family: Dillon

full_name: Joseph S. Dillon

given: Joseph S.

family: Kulke

full_name: Matthew H. Kulke

given: Matthew H.

family: Hörsch

full_name: Dieter Hörsch

given: Dieter

family: Anthony

full_name: Lowell B. Anthony

given: Lowell B.

family: Warner

full_name: Richard R. P. Warner

given: Richard R. P.

family: Bergsland

full_name: Emily Bergsland

given: Emily

family: Welin

full_name: Staffan Welin

given: Staffan

family: O’Dorisio

full_name: Thomas M. O’Dorisio

given: Thomas M.

family: Kunz

full_name: Pamela L. Kunz

given: Pamela L.

family: McKee

full_name: Chad McKee

given: Chad

family: Lapuerta

full_name: Pablo Lapuerta

given: Pablo

family: Banks

full_name: Phillip Banks

given: Phillip

family: Pavel

full_name: Marianne Pavel

given: Marianne

repository_institution: Uppsala University - Uppsala University Publications

ReferenceCitation: Hudgens S, Ramage J, Kulke M, Bergsland E, Anthony L, Caplin M, Öberg K, Pavel M, Gable J, Banks P, Yang QM, Lapuerta P. Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome. J Patient Rep Outcomes. 2019 Oct 26;3(1):64. doi: 10.1186/s41687-019-0153-y.

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

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Cella D, Beaumont JL, Hudgens S, Marteau F, Feuilly M, Houchard A, Lapuerta P, Ramage J, Pavel M, Hörsch D, Kulke MH. Relationship Between Symptoms and Health-related Quality-of-life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR. Clin Ther. 2018 Dec;40(12):2006-2020.e2. doi: 10.1016/j.clinthera.2018.10.008. Epub 2018 Nov 24.

ReferenceCitation: Weickert MO, Kaltsas G, Hörsch D, Lapuerta P, Pavel M, Valle JW, Caplin ME, Bergsland E, Kunz PL, Anthony LB, Grande E, Öberg K, Welin S, Lombard-Bohas C, Ramage JK, Kittur A, Yang QM, Kulke MH. Changes in Weight Associated With Telotristat Ethyl in the Treatment of Carcinoid Syndrome. Clin Ther. 2018 Jun;40(6):952-962.e2. doi: 10.1016/j.clinthera.2018.04.006. Epub 2018 May 1.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

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

acronym: TELESTAR (Telotristat Etiprate for Somatostatin Analogue Refractory Carcinoid Syndrome)

location_facility:
Lexicon Invetigational Site
Lexicon Investigational Site

title: A Phase 3, Randomized, Placebo-controlled, Parallel Group, Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of Telotristat Etiprate (LX1606) in Patients With Carcinoid Syndrome Not Adequately Controlled by Somatostatin Analog (SSA) Therapy

summary: The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.


title: A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations

summary: The purpose of this study is to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 genetic aberrations (GA).

ipd_sharing: No

lead_sponsor: Basilea Pharmaceutica

location_country:
Italy
Brazil
Spain
Germany
France
Poland
Belgium
Argentina
Australia
Russian Federation
Turkey
United States
United Kingdom
Korea, Republic of

location_facility: Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

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

location_facility: Baskent University Adana Application and Research Center

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

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

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

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

location_facility: Seoul National University Bundang Hospital

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

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

location_facility: Liga Norte-Rio-Grandense Contra o Câncer

location_facility: SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Fundación Favaloro para la Docencia e Investigación Médica

location_facility: Chonnam National University Hwasun Hospital

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

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

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan


title: A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid

summary: Study to determine the effect of the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF) in patients with Primary Biliary Cholangitis (also known as PBC).

ReferenceType: background

ReferenceCitation: Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906.

ReferenceCitation: European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6.

lead_sponsor: Intercept Pharmaceuticals

location_country:
Austria
Sweden
Netherlands
Spain
Croatia
Czechia
France
Greece
Israel
Lithuania
Hungary
Australia
Belgium
Ireland
Norway
Estonia
Germany
United Kingdom
Korea, Republic of

location_facility: Artroscan s.r.o., Gastroenterologicka ambulance

location_facility: Institute of Cellular Medicine, Newcastle University

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: University of Athens - Hippokration General Hospital

location_facility: Hadassah Ein-Karem Medical Center - Liver unit

location_facility: Severance Hospital Yonsei University Health System

location_facility: Consorcio Hospital General Universitario

location_facility: Universitetet i Oslo - Akershus Universitetssykehus (AHUS)

location_facility: Hospital of Lithuanian University of Health Sciences, Kauno Klinikos

location_facility: Department of Medicine and Research Laboratory of Internal Medicine, University Hospital of Larissa

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Fundacio Clinic Per La Recerca Biomedica


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

summary: A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

lead_sponsor: Alector Inc.

location_country:
Italy
United States
Netherlands
Germany
France
Poland
Argentina
Australia
New Zealand
Spain
Canada
United Kingdom

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

location_facility: Alzheimers Research and Treatment Center

location_facility: Columbia University College of Physicians and Surgeons

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Fundacion ACE Instituto Catalan de Neurociencias

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Charité - Universitätsmedizin Berlin (CBF)

location_facility: Greater Manchester Mental Health NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Centro de Psiquiatría Biológica Instituto Senecta

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Synexus Clinical Research US, Inc - The Villages

location_facility: Ospedale S Giovanni Calibita Fatebenefratelli

location_facility: IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

location_facility: AMITA Health Clinical Research Institute

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: True North Clinical Research - New Minas


title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients With Bipolar I Disorder

summary: The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: OPKO Health, Inc.

location_country:
France
Czechia
Bulgaria
Poland
Romania
Spain
Turkey
United States
Canada

status_simplified: Unknown


location_country:
Belgium
Australia
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Hong Kong
Netherlands
Switzerland
Singapore
Puerto Rico
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Israel
New Zealand
Spain

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Children's Hospital Colorado; Center For Cancer/Blood Disorder

location_facility: University of New Mexico; Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie

location_facility: Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU

location_facility: Centre Oscar Lambret; Service de Pediatrie

location_facility: Consultants in Medical Oncology and Hematology

location_facility: Klinik Kinderheikunde I des Zentrums für Kinder- und Jugendmedizin, Universität Heidelberg

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Seoul National University Hospital- Pediatric Site

location_facility: Western Regional Medical Center at Cancer Treatment Centers of America

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Institut de Cancerologie Gustave-Roussy (IGR)

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center

location_facility: Seoul National University Hospital- Adult Site

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: National Cancer Centre; Medical Oncology

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: Aarhus Universitetshospital Skejby; Institut for Klinisk Medicin, Molekylær Medicinsk afdeling

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Taipei Veterans General Hospital; Department of Oncology

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

location_facility: CHUV Lausanne Médecine Oncologie ; Département d'Oncologie médicale - BH09 - Bureau 7

location_facility: University of New Mexico Comprehensive Cancer Center - South Telshore Blvd; Drug Supplies

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Seoul National University Bundang Hospital

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Cancer Treatment Centers of America; Eastern Regional Medical Center

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

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

location_facility: West China Hospital - Sichuan University

location_facility: Christiana Care Health Srvcs; Helen F Graham Can Center

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie

location_facility: National Taiwan University Hospital; Oncology

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Inselspital, Klinik und Poliklinik für Medizinische Onkologie

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: London Health Sciences Centre · Victoria Hospital; Department of Medicine

location_facility: Praxis für Hämatologie, Onkologie und Palliativmedizin

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

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

location_facility: Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

location_facility: Chang Gung Memorial Hospital-Linkou; Dept of Oncology

location_facility: Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica

location_facility: Ospedale Regionale di Bellinzona Medizin Onkologie

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie

location_facility: Northwest Medical Specialties, PLLC; Research Department

location_facility: University of California at San Francisco

title: Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

summary: TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.


title: A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis

acronym: FENhance

summary: A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

location_country:
Italy
Austria
Brazil
Guatemala
India
Mexico
France
Bulgaria
Greece
Korea, Republic of
Poland
Russian Federation
Turkey
Denmark
United States
Canada

location_facility: IBISMED Wielospecjalistyczne Centrum Medyczne

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Unidad de Investigación en Salud; Psiquiatria

location_facility: Federal center of brain research and neurotechnologies

location_facility: Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

location_facility: Gazi University Medical Faculty; Departmant of Neurology.

location_facility: Sydvestjysk Sygehus Esbjerg; Neurologisk Afd., Skleroseklinikken

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Hospital Santa Marcelina; AME - Ambulatório de Especialidades Médicas

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: University General Hospital of Ioannina; Neurology Clinic

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Neuro Institute of New England P.C.; Research

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

location_facility: University of Cincinnati; Department of Neurology

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

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

location_facility: Hôpital Charles Nicolle; Service de Neurologie

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Regional Clinical Hospital N.A. Semashko; Neurology

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases

location_facility: University General Hospital of Larisa; Neurology Clinic

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

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: National Center of Social Significant Disease

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

location_facility: Regional clinical hospital named after prof. S.V. Ochapovsky

location_facility: Sancaktepe Training and Research Hospital; Neurology

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

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

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

location_facility: MUCH - Montreal Neurological Institute & Hospital

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla


title: A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

summary: The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo.

status: Completed

ReferenceCitation: Hughes R, Dalakas MC, Merkies I, Latov N, Léger JM, Nobile-Orazio E, Sobue G, Genge A, Cornblath D, Merschhemke M, Ervin CM, Agoropoulou C, Hartung HP; FORCIDP Trial Investigators. Oral fingolimod for chronic inflammatory demyelinating polyradiculoneuropathy (FORCIDP Trial): a double-blind, multicentre, randomised controlled trial. Lancet Neurol. 2018 Aug;17(8):689-698. doi: 10.1016/S1474-4422(18)30202-3. Epub 2018 Jul 9. Erratum in: Lancet Neurol. 2018 Nov;17(11):933.

family: Hughes

full_name: Richard Hughes

given: Richard

family: Dalakas

full_name: Marinos C Dalakas

given: Marinos C

family: Merkies

full_name: Ingemar Merkies

given: Ingemar

family: Latov

full_name: Norman Latov

given: Norman

family: Léger

full_name: Jean-Marc Léger

given: Jean-Marc

family: Nobile-Orazio

full_name: Eduardo Nobile-Orazio

given: Eduardo

family: Sobue

full_name: Gen Sobue

given: Gen

family: Genge

full_name: Angela Genge

given: Angela

family: Cornblath

full_name: David Cornblath

given: David

family: Merschhemke

full_name: Martin Merschhemke

given: Martin

family: Ervin

full_name: Carolyn Marie Ervin

given: Carolyn Marie

family: Agoropoulou

full_name: Catherine Agoropoulou

given: Catherine

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Day

full_name: Timothy Day

given: Timothy

family: Spies

full_name: Judith Spies

given: Judith

family: Roberts

full_name: Leslie Roberts

given: Leslie

family: Van Damme

full_name: Philip Van Damme

given: Philip

family: Van den Bergh

full_name: Peter YK Van den Bergh

given: Peter YK

family: Maertens de Noordhout

full_name: Alain Maertens de Noordhout

given: Alain

family: Dionne

full_name: Annie Dionne

given: Annie

family: Larue

full_name: Sandrine Larue

given: Sandrine

family: Massie

full_name: Rami Massie

given: Rami

family: Melanson

full_name: Michel Melanson

given: Michel

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

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

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Greece
Israel
Japan
Poland
Belgium
Australia
Spain
Canada
United Kingdom


title: Randomized, Double-blind, Phase 3 Study of TAS-102 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

acronym: RECOURSE

summary: The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

ReferenceCitation: Yoshino T, Cleary JM, Van Cutsem E, Mayer RJ, Ohtsu A, Shinozaki E, Falcone A, Yamazaki K, Nishina T, Garcia-Carbonero R, Komatsu Y, Baba H, Argilés G, Tsuji A, Sobrero A, Yamaguchi K, Peeters M, Muro K, Zaniboni A, Sugimoto N, Shimada Y, Tsuji Y, Hochster HS, Moriwaki T, Tran B, Esaki T, Hamada C, Tanase T, Benedetti F, Makris L, Yamashita F, Lenz HJ. Neutropenia and survival outcomes in metastatic colorectal cancer patients treated with trifluridine/tipiracil in the RECOURSE and J003 trials. Ann Oncol. 2020 Jan;31(1):88-95. doi: 10.1016/j.annonc.2019.10.005.

family: Yoshino

full_name: T. Yoshino

given: T.

family: Cleary

full_name: J.M. Cleary

family: Van Cutsem

full_name: E. Van Cutsem

given: E.

family: Mayer

full_name: R.J. Mayer

family: Ohtsu

full_name: A. Ohtsu

given: A.

family: Shinozaki

full_name: E. Shinozaki

family: Falcone

full_name: A. Falcone

family: Yamazaki

full_name: K. Yamazaki

given: K.

family: Nishina

full_name: T. Nishina

family: Garcia-Carbonero

full_name: R. Garcia-Carbonero

given: R.

family: Komatsu

full_name: Y. Komatsu

given: Y.

family: Baba

full_name: H. Baba

given: H.

family: Argilés

full_name: G. Argilés

given: G.

family: Tsuji

full_name: A. Tsuji

family: Sobrero

full_name: A. Sobrero

family: Yamaguchi

full_name: K. Yamaguchi

family: Peeters

full_name: M. Peeters

given: M.

family: Muro

full_name: K. Muro

family: Zaniboni

full_name: A. Zaniboni

family: Sugimoto

full_name: N. Sugimoto

given: N.

family: Shimada

full_name: Y. Shimada

full_name: Y. Tsuji

family: Hochster

full_name: H.S. Hochster

family: Moriwaki

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of Tsukuba - Terrestrial Environment Research Center

ReferenceCitation: Van Cutsem E, Mayer RJ, Laurent S, Winkler R, Grávalos C, Benavides M, Longo-Munoz F, Portales F, Ciardiello F, Siena S, Yamaguchi K, Muro K, Denda T, Tsuji Y, Makris L, Loehrer P, Lenz HJ, Ohtsu A; RECOURSE Study Group. The subgroups of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo with best supportive care in patients with metastatic colorectal cancer. Eur J Cancer. 2018 Feb;90:63-72. doi: 10.1016/j.ejca.2017.10.009. Epub 2017 Dec 21.

ReferenceCitation: Longo-Muñoz F, Argiles G, Tabernero J, Cervantes A, Gravalos C, Pericay C, Gil-Calle S, Mizuguchi H, Carrato-Mena A, Limón ML, Garcia-Carbonero R. Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial. Clin Transl Oncol. 2017 Feb;19(2):227-235. doi: 10.1007/s12094-016-1528-7. Epub 2016 Jul 21.

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

ReferenceCitation: Mayer RJ, Van Cutsem E, Falcone A, Yoshino T, Garcia-Carbonero R, Mizunuma N, Yamazaki K, Shimada Y, Tabernero J, Komatsu Y, Sobrero A, Boucher E, Peeters M, Tran B, Lenz HJ, Zaniboni A, Hochster H, Cleary JM, Prenen H, Benedetti F, Mizuguchi H, Makris L, Ito M, Ohtsu A; RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015 May 14;372(20):1909-19. doi: 10.1056/NEJMoa1414325.

title: Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer

location_country:
Italy
Austria
Sweden
Germany
France
Czechia
Japan
Ireland
Australia
Belgium
Spain
United States
United Kingdom

location_facility: Hospital Clínico Universitario de Valencia

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Institute of Oncology and Rehabilitation Ples

location_facility: Universita Delgi Studi de Genova (UNIGE)- Azienda Ospedaliera. Universitaria "San Martino" (Ospedale San Martino)

location_facility: California Cancer Associates for Research and Excellence

location_facility: Klinika onkologie a radioteraie, Facultni nemocnice Hradec Kralove

location_facility: Medizinische Klinik am Krankenhaus Nordwest GmbH

location_facility: Fondazione IRCCS Instituto Nazionale dei Tumori Milano

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Hickman Cancer Center at Flower Hospital

location_facility: Klinikum der Universität München - Großhadern

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: KKR Sapporo Medical Center TONAN-Hospital

location_facility: Staedtisches Klinikum Muenchen / Klinikum Neuperlach

location_facility: Hospital Universitario Morales Messeguer

location_facility: Hospital General Universitario de Valencia

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Seconda Universita degli Studi de Napoli

location_facility: University College London Hospitals Foundation NHS Trust

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Leuven University Hospital - Campus Gasthuiseberg

location_facility: Uniklinik der Martin-Luther-Universitaet Halle-Wittenberg

location_facility: Kobe City Medical Center General Hospital

location_facility: Hematology/Oncology Associates of Fredericksburg

location_facility: Universitatsklinikum Carl Gustav Carus - Dresden

location_facility: Fundacion Jimenez Diaz - Universidad Autonoma de Madrid

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases


ReferenceCitation: Tadayoni R, Waldstein SM, Boscia F, Gerding H, Gekkieva M, Barnes E, Das Gupta A, Wenzel A, Pearce I; BRIGHTER Study Group. Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study. Ophthalmology. 2017 Dec;124(12):1778-1787. doi: 10.1016/j.ophtha.2017.06.027. Epub 2017 Aug 12. Erratum in: Ophthalmology. 2018 Mar;125(3):463.

family: Tadayoni

full_name: Ramin Tadayoni

given: Ramin

family: Waldstein

full_name: Sebastian M. Waldstein

given: Sebastian M.

family: Boscia

full_name: Francesco Boscia

given: Francesco

family: Gerding

full_name: Heinrich Gerding

given: Heinrich

family: Gekkieva

full_name: Margarita Gekkieva

given: Margarita

family: Barnes

full_name: Elizabeth Barnes

given: Elizabeth

family: Das Gupta

full_name: Ayan Das Gupta

given: Ayan

family: Wenzel

full_name: Andreas Wenzel

given: Andreas

family: Pearce

full_name: Ian Pearce

given: Ian

journal_name: Ophthalmology

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S, Wenzel A, Barnes E, Gekkieva M, Pilz S, Monés J; BRIGHTER study group. Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER. Ophthalmology. 2016 Jun;123(6):1332-44. doi: 10.1016/j.ophtha.2016.02.030. Epub 2016 Mar 30.

family: Priglinger

full_name: Siegfried Priglinger

given: Siegfried

title: Individualized Stabilization Criteria–Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion

location_country:
Italy
Sweden
Switzerland
Netherlands
Spain
United Kingdom
France
Poland
Greece
Slovakia
Hungary
Australia
Ireland
Portugal
Denmark
Canada
Czech Republic

title: A 24-month, Phase IIIb, Open-label, Randomized, Active Controlled, 3-arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy or With Adjunctive Laser Photocoagulation in Comparison to Laser Photocoagulation in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

summary: This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.


title: A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin

acronym: PEDESTAL

summary: The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

ReferenceCitation: Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7. Review.

family: Heim

full_name: Markus H. Heim

given: Markus H.

journal_name: Nature Reviews Immunology

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
Brazil
Switzerland
Germany
France
Czechia
Poland
Israel
Belgium
Russian Federation
Spain
Canada
United Kingdom

location_facility: Infectious Disease Research Institute, Inc.

location_facility: Liver And Intestinal Research Centre (Lair)

location_facility: University Of California, San Francisco/Sf General Hospital

location_facility: Gastrointestinal Research Institute (G.I.R.I.)

location_facility: Va Greater Los Angeles Healthcare System

location_facility: Gastrointestinal Specialists Of Georgia Pc

location_facility: Bon Secours St. Mary'S Hospital Of Richmond, Inc.

location_facility: Birmingham Gastroenterology Associates, P.C.

status_simplified: Completed


title: A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection

acronym: Hallmark QUAD

summary: The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12.

ReferenceCitation: Jensen D, Sherman KE, Hézode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018. Epub 2015 Feb 19.

family: Jensen

full_name: Donald Jensen

given: Donald

family: Sherman

full_name: Kenneth E. Sherman

given: Kenneth E.

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: de Ledinghen

full_name: Victor de Ledinghen

given: Victor

family: Tran

full_name: Albert Tran

given: Albert

family: Elkhashab

full_name: Magdy Elkhashab

given: Magdy

family: Younes

full_name: Ziad H. Younes

given: Ziad H.

family: Kugelmas

full_name: Marcelo Kugelmas

given: Marcelo

family: Mauss

full_name: Stefan Mauss

family: Everson

full_name: Gregory Everson

given: Gregory

family: Luketic

full_name: Velimir Luketic

given: Velimir

family: Vierling

full_name: John Vierling

given: John

family: Serfaty

full_name: Lawrence Serfaty

given: Lawrence

family: Brunetto

full_name: Maurizia Brunetto

given: Maurizia

family: Heo

full_name: Jeong Heo

given: Jeong

family: Bernstein

full_name: David Bernstein

given: David

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Hennicken

full_name: Delphine Hennicken

given: Delphine

family: Mendez

full_name: Patricia Mendez

given: Patricia

family: Hughes

full_name: Eric Hughes

given: Eric

family: Noviello

full_name: Stephanie Noviello

given: Stephanie

location_country:
Italy
United States
Sweden
Switzerland
Mexico
Netherlands
Germany
France
Argentina
Russian Federation
Spain
Denmark
Canada
Korea, Republic of
Taiwan

location_facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: University Of Colorado Denver And Hospital

location_facility: University Of North Carolina At Chapel Hill School Of Med

location_facility: University Of Miami Schiff Center For Liver Diseases


title: Safety and Efficacy of Inhaled Pegylated Adrenomedullin (PEG-ADM) in Patients Suffering From Acute Respiratory Distress Syndrome (ARDS): a Double-blind, Randomized, Placebo-controlled, Multicenter Phase 2a/b Clinical Trial

summary: The study is composed of two parts. In part A of the study two active doses of inhaled pegylated adrenomedullin (PEG-ADM) will be compared regarding safety and efficacy to a substance that has no therapeutic effect (placebo) in order to find an optimal and safe of the study drug. In part B of the study the highest dose that is considered safe and has demonstrated efficacy will be taken forward to collect information how well patients suffering from Acute Respiratory Distress Syndrome (ARDS) respond to treatment with inhaled pegylated adrenomedullin (PEG-ADM) compared to treatment with placebo. ARDS is a type of lung failure that cause fluid to build up in the lungs making breathing difficult or impossible.

ipd_sharing_description:
Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
Austria
Netherlands
France
Czechia
Greece
Israel
Belgium
Russian Federation
Spain
Germany
United Kingdom

location_facility: Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: Sci-Res. Institute of Emergency Care n.a. N.V. Sklifosovsky

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim

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

location_facility: Klinikum der Universität München Grosshadern

location_facility: General Hospital of Athens "Evangelismos"

location_facility: University General Hospital of Heraklion

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: First City Clinical Hospital n.a. E.E. Volosevich

location_facility: SOTIRIA General Hospital of Chest Diseases


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

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

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Malaysia
Greece
Belgium
Australia
Russian Federation
Taiwan
Croatia
France
Japan
Poland
Thailand
Argentina
Korea, Republic of
Colombia
South Africa
Chile
Netherlands
Philippines
Vietnam
Bulgaria
Singapore
China
Germany
United States
Italy
Mexico
Tunisia
Georgia
Spain
Turkey

location_facility: Andreas Syggros Hospital of Cutaneous & Venereal Diseases

location_facility: The First Hospital of Chinese Medical University

location_facility: Chang Gung Medical Foundation (CGMF) - Linkou Bran

location_facility: Hedi Chaker Hospital, Department of Dermatology

location_facility: National Hospital of Dermatology and Venereology

location_facility: Tianjin Medical University General Hospital

location_facility: Second Affiliated Hospital of Xi'an JiaoTong University

location_facility: Sun yet-sen Memorial Hospital, Sun yet-sen Univesity

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: General Hospital of Thessaloniki "Ippokrateio"

location_facility: ,,KANVENI - Scientific/Research National Center of Dermatology and Venereology'' Limited Liability Company

location_facility: Centro de Investigación de Enfermedades Autoinmunes S.C.

location_facility: The limited liability company "Clinic USI 4D"

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Bezmi Alem Valide Sultan Vakif Gureba Egitim ve Arastirma Hastanesi

location_facility: University of Cape Town - Lung Institute

location_facility: Hospital General de Mexico Dr. Eduardo Liceaga

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Washington University School of Medicine

location_facility: FSBEI HE "Kirov State Medical University"

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Psoriahue Medicina Interdisciplinaria S.R.L

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: University Multiprofile Hospital 'Alexandrovska', Sofia

location_facility: Center for Skin Research, Testing and Product Development

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

location_facility: Hospital Clínico de la Universidad de Chile José Joaquín Aguirre

location_facility: Uludag University Medicine Faculty Departmant of Dermatology

location_facility: LTD Israeli-Georgian Medical Research Clinic "Helsicore"

location_facility: Affiliated Hospital of Tianjin institute of Chinese medicine

location_facility: Asociación de Fomento y Sala de primeros auxilios" Alberto Mignaburu"

location_facility: CIREEM SAS (Centro de Investigación en Reumatología y Especialidades Médicas)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Tokyo Medical University Ibaraki Medical Center

title: Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP

summary:
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study. The study is open to people who had GPP flare-ups in the past but whose skin is clear or almost clear when they join the study. The purpose of the study is to test 3 different doses of a medicine called spesolimab and to see whether it helps to prevent GPP flare-ups.

Participants are put into 4 groups by chance. Three groups get different doses of spesolimab. The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any medicine.

Spesolimab and placebo are given as an injection under the skin. Participants are in the study for about 1 year and 4 months. During this time, they visit the study site about 15 times. For the first 11 months, participants get spesolimab or placebo injections every month. At the study visits, the doctors check participants' skin for signs of a new GPP flare-up. The doctors also check the general health of the participants.

If a participant has a GPP flare-up during the study, more visits may be necessary. In case of a flare-up, participants get a dose of spesolimab as an infusion into a vein.


title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination With Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MERMAID-1)

summary: This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery

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

lead_sponsor: AstraZeneca

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Vietnam
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey


ReferenceCitation: Bruggeman LA, Sedor JR, O'Toole JF. Apolipoprotein L1 and mechanisms of kidney disease susceptibility. Curr Opin Nephrol Hypertens. 2021 May 1;30(3):317-323. doi: 10.1097/MNH.0000000000000704. Review.

family: Bruggeman

full_name: Leslie A. Bruggeman

given: Leslie A.

family: Sedor

full_name: John R. Sedor

given: John R.

family: O’Toole

full_name: John F. O’Toole

given: John F.

journal_name: Current Opinion in Nephrology & Hypertension

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

status: Active, not recruiting

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
United States
United Kingdom
Puerto Rico
France

location_facility: King's College Hospital NHS Foundation Trust - Guthrie Clinic

location_facility: UNC Kidney Center Division of Nephrology & Hypertension

location_facility: Renal and Transplant Associates of New England, PC

location_facility: Duke University School of Medicine - Duke Molecular Physiology Institute

location_facility: Kidney and Hypertension Specialists of Miami

location_facility: Université Paris-Descartes / Hôpital Européen Georges Pompidou

location_facility: University of Alabama at Birmingham - The Kirklin Clinic

location_facility: Paragon Health, PC d/b/a Nephrology Center, PC

location_facility: Morehouse School of Medicine, Grady Memorial Hospital

location_facility: The George Washington University Medical Faculty Associates - Kidney Disease & Hypertension

location_facility: Nevada Kidney Disease and Hypertension Centers

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: South Carolina Nephrology and Hypertension Center, Inc.

location_facility: Hopitaux Universitaires Est Parisien - Hopital Tenon

location_facility: Service de Nephrologie - Hopital Universitaire Necker

location_facility: Nephrology and Hypertension Associates, LTD

location_facility: University Hospitals of Leicester NHS Trust - Leicester General Hospital

title: A Phase 2a, Open-label, Single-arm, 2-Part Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis

summary: This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in subjects with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis (FSGS).


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Switzerland
France
Israel
Australia
United States

acronym: Ph 1/2 Substudy of Oncological Treatment(s) in PD-1 Refractory MEL

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022)

location_facility: Hadassah Ein Karem Jerusalem ( Site 1702)

location_facility: Rambam Health Care Campus-Oncology ( Site 1704)

location_facility: The Angeles Clinic and Research Institute ( Site 1009)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 1602)

location_facility: Inova Schar Cancer Institute ( Site 1011)

location_facility: Tasman Oncology Research Pty Ltd ( Site 1403)

location_facility: University of Texas MD Anderson Cancer Center ( Site 1006)

location_facility: Universitaetsspital Zuerich ( Site 1601)

location_facility: West Cancer Center - East Campus ( Site 1014)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 1377)

location_facility: Oregon Health & Science University ( Site 1013)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 1302)

location_facility: University of Pennsylvania Abramson Cancer Center ( Site 1008)

location_facility: Istituto Europeo di Oncologia ( Site 1301)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 1107)

location_facility: Centre Hospitalier Lyon Sud ( Site 1102)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 1012)

location_facility: Providence Saint John's Health Center ( Site 1010)

location_facility: Calvary Mater Newcastle-Medical Oncology ( Site 1404)

location_facility: Melanoma Institute Australia ( Site 1402)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 1355)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1399)

title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02A

summary:
Substudy 02A is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.


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 expert 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.

location_country:
Finland
Malaysia
Greece
Australia
Belgium
Russian Federation
Oman
Taiwan
India
France
Japan
Lithuania
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Chile
Saudi Arabia
Switzerland
Netherlands
Singapore
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Czechia
Israel
Spain
Turkey

location_facility: University of Iowa Hospitals and Clinics Univ of Iowa Hosp & Clinic

location_facility: Weill Cornell Medicine NewYork Presbyterian Hospital

location_facility: Yale University School of Medicine Smilow Cancer Hospital

location_facility: University of Virginia University of Virginia

location_facility: University of Rochester Medical Center Dept.ofUniv.Rochester/JPWilmot

location_facility: Northwestern University Div of Hematology/Oncology

title: A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

summary:
This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator.

The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.


title: Micra AV Transcatheter Pacing System Post-Approval Registry

acronym: Micra AV PAS

summary:
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release.

The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Italy
United States
Serbia
Switzerland
Netherlands
Germany
France
Czechia
Greece
Israel
Malaysia
Norway
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand-Gabriel-Montpied

location_facility: The Ohio State University Wexner Medical Center

location_facility: Azienda Ospedaliera Sepdali Civili di Brescia

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: Universitätsklinikum Jena - Friedrich Schiller Universität

location_facility: Indiana University Health Methodist Research Institute

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

location_facility: University of Pittsburgh Medical Center UPMC Shadyside

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: TidalHealth Peninsula Regional Medical Center

location_facility: University of Kansas Medical Center Research Institute

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Atlantic Health/Morristown Medical Center

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust


ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

name: Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, OR 97213, USA

family: Taylor

full_name: Matthew H Taylor

given: Matthew H

name: Department of Clinical Oncology, Merck & Co. Inc., Kenilworth, NJ 07033, USA

family: Schmidt

full_name: Emmett V Schmidt

given: Emmett V

name: Department of Clinical Research, Eisai Inc., Woodcliff Lake, NJ 07677, USA

family: Dutcus

full_name: Corina Dutcus

given: Corina

family: Pinheiro

full_name: Elaine M Pinheiro

given: Elaine M

name: Biomarker Research Translational Science Department, Eisai Co., Ltd., Tokyo, 112-0002, Japan

family: Funahashi

full_name: Yasuhiro Funahashi

given: Yasuhiro

family: Lubiniecki

full_name: Gregory Lubiniecki

name: The START Center for Cancer Care, San Antonio, TX 78229, USA

family: Rasco

full_name: Drew Rasco

given: Drew

journal_name: Future Oncology

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

intervention_type: Procedure

location_country:
Australia
Denmark
Taiwan
Ukraine
France
Japan
Thailand
Korea, Republic of
Colombia
Chile
Netherlands
Hungary
Puerto Rico
Portugal
China
Germany
United States
United Kingdom
Italy
Brazil
Israel
New Zealand
Spain
Turkey

location_facility: Puerto Rico Medical Research Center LLC ( Site 0523)

location_facility: Yokohama City University Medical Center ( Site 0351)

location_facility: Osaka International Cancer Institute ( Site 0357)

location_facility: Harbin Medical University Cancer Hospital ( Site 0090)

location_facility: Nara Medical University Hospital ( Site 0359)

location_facility: Policlinico Universitario -Agostino Gemelli ( Site 0328)

location_facility: Universitaetsklinikum Leipzig ( Site 0202)

location_facility: Hadassah Ein Karem Jerusalem ( Site 0303)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 0265)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0503)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0609)

location_facility: Ad-Vance Medical Research LLC ( Site 0527)

location_facility: Houston Methodist Research Institute ( Site 0784)

location_facility: University Medical Center New Orleans ( Site 0733)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 0629)

location_facility: Centro Hospitalar de Lisboa Central, EPE - Hosp St. Ant dos Capuchos ( Site 0505)

location_facility: Ramathibodi Hospital, Mahidol University ( Site 0628)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 0648)

location_facility: Penn State Hershey Medical Center ( Site 0766)

location_facility: West China Hospital of Sichuan University ( Site 0119)

location_facility: Odense Universitetshospital ( Site 0160)

location_facility: Arizona Oncology Associates PC- HOPE ( Site 0770)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0744)

location_facility: CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0185)

location_facility: Hospital Clinico San Carlos ( Site 0597)

location_facility: Severance Hospital Yonsei University Health System ( Site 0564)

location_facility: Fundacion de Investigacion de Diego ( Site 0522)

location_facility: Peking Union Medical College Hospital ( Site 0087)

location_facility: Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 0501)

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico ( Site 0325)

location_facility: USC Norris Comprehensive Cancer Center ( Site 0717)

location_facility: Edwards Comprehensive Cancer Center ( Site 0786)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0267)

location_facility: National Cheng Kung University Hospital ( Site 0608)

location_facility: Zhongshan Hospital Fudan University ( Site 0084)

location_facility: Henry Ford Hospital-GI/Hepatology Research ( Site 0735)

location_facility: The First Hospital of Kunming ( Site 0124)

location_facility: Hiroshima University Hospital ( Site 0360)

location_facility: Administradora Country S.A. ( Site 0137)

location_facility: Charite - Universitaetsmedizin ( Site 0204)

location_facility: Maastricht University Medical Centre ( Site 0440)

location_facility: 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0110)

location_facility: Scripps Clinic Torrey Pines ( Site 0714)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0598)

location_facility: Mountain States Tumor Institute ( Site 0773)

location_facility: The Third Affiliated Hospital of Naval Medical University ( Site 0123)

location_facility: Korea University Guro Hospital ( Site 0573)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0720)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 0669)

location_facility: A.P.H. Paris, Hopital Henri Mondor ( Site 0179)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0441)

location_facility: The University of Tokyo Hospital ( Site 0348)

location_facility: Juntendo University Hospital ( Site 0371)

location_facility: Seoul National University Hospital ( Site 0567)

location_facility: Kaohsiung Medical University Hospital ( Site 0611)

location_facility: Universitaetsklinikum Halle ( Site 0213)

location_facility: Fundacao Dr Amaral Carvalho ( Site 0050)

location_facility: Zhujiang Hospital of Southern Medical University ( Site 0115)

location_facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 0367)

location_facility: Aarhus Universitets hospital ( Site 0175)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0673)

location_facility: The Ohio State University Wexner Medical Center ( Site 0759)

location_facility: University of Cincinnati Medical Center ( Site 0791)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0345)

location_facility: Centro Hospitalar e Universitario de Coimbra ( Site 0502)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0207)

location_facility: Chonnam National University Hwasun Hospital ( Site 0572)

location_facility: University of Iowa Hospital and Clinics ( Site 0729)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0361)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 0571)

location_facility: Shalimov s NI of Surgery and Transplantation ( Site 0671)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0215)

location_facility: Fujian Provincial Cancer Hospital ( Site 0085)

location_facility: National Cancer Center Hospital East ( Site 0347)

location_facility: Hacettepe University Medical Faculty ( Site 0653)

location_facility: Pusan National University Hospital ( Site 0568)

location_facility: University of Kansas Cancer Center ( Site 0731)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 0654)

location_facility: Az Osp di Rilievo Nazionale A. Cardarelli ( Site 0329)

location_facility: Princess Alexandra Hospital ( Site 0006)

location_facility: ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0331)

location_facility: The First Affiliated Hospital of Soochow University ( Site 0120)

location_facility: Nanfang Hospital of Southern Medical University ( Site 0088)

location_facility: Hunan Provincial People's Hospital ( Site 0113)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0607)

location_facility: Kyungpook National University Hospital ( Site 0569)

location_facility: Fudan University Shanghai Cancer Center ( Site 0106)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0365)

location_facility: Guangdong Provincial People s Hospital ( Site 0100)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0043)

location_facility: Centro Hospitalar do Porto, E.P.E. - Hospital Geral de Sto. Antonio ( Site 0504)

location_facility: Seoul National University Bundang Hospital ( Site 0570)

location_facility: The First Affiliated Hospital of Fujian Medical University ( Site 0089)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0650)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0098)

location_facility: Clinica de Oncologia Reichow ( Site 0052)

location_facility: Saitama Medical University Hospital ( Site 0370)

location_facility: National Taiwan University Hospital ( Site 0606)

location_facility: Japanese Red Cross Osaka Hospital ( Site 0356)

location_facility: VA Caribbean Healthcare System ( Site 0524)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0064)

location_facility: Izmir Medical Park Hospital Department of Medical Oncology ( Site 0649)

location_facility: Universitaetsklinikum Freiburg ( Site 0199)

location_facility: Erasmus University Medical Center ( Site 0439)

location_facility: China Medical University Hospital-Surgical Department ( Site 0610)

location_facility: Hospital General Universitario de Valencia ( Site 0595)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0136)

location_facility: OHSU Center for Health & Healing ( Site 0746)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0108)

location_facility: Mengchao Hepatobiliary Hospital of Fujian Medical University ( Site 0121)

location_facility: Kagawa Prefectural Central Hospital ( Site 0364)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0046)

location_facility: Toranomon Hospital Kajigaya ( Site 0369)

location_facility: Medizinische Hochschule Hannover ( Site 0200)

location_facility: Saga-Ken Medical Centre Koseikan ( Site 0363)

location_facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 0180)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 0065)

location_facility: Kanazawa University Hospital ( Site 0354)

location_facility: Jichi Medical University Hospital ( Site 0353)

location_facility: Hospital Universitario Puerta de Hierro ( Site 0596)

location_facility: Chinese People s Liberation Army Army Characteristic Medical Center ( Site 0117)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0694)

location_facility: Konya Necmettin Erbakan University Medical Faculty ( Site 0652)

type: Registry Identifier

title: A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

summary: The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).


title: DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma

acronym: DREAMM 7

summary: This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.

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

lead_sponsor: GlaxoSmithKline

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


title: Prospective, Open-Label Clinical Study of Andexanet Alfa in Patients Receiving FXa (Activated Factor X) Inhibitor Who Require Urgent Surgery

acronym: Annexa-S

summary: Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Austria
Germany
France
Japan
Israel
United States

location_facility: University of Arizona-Banner Health-Phoenix

location_facility: Carolinas Medical Center - Atrium Health

location_facility: Allegehny Health Network Allegheny General Hosptial

location_facility: University of Arizona-Banner Health-Tucson

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Texas Tech Health Sciences Center El Paso

location_facility: Wexner Medical Center at The Ohio State University

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Ascension St. John Clinical Research Institute

location_facility: Japanese Red Cross Nagoya Daini Hospital


title: Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

summary: A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

ipd_sharing: Undecided

lead_sponsor: NGM Biopharmaceuticals, Inc

location_country:
Hong Kong
Germany
France
Poland
Belgium
Australia
Puerto Rico
Spain
United States
United Kingdom