acronym: SMART-C

lead_sponsor: Kirby Institute

summary:
The aim of this study is to determine if treatment monitoring schedule for chronic HCV patients treated with glecaprevir (300mg)/pibrentasvir (120mg) can be simplified.

Data has shown that direct acting antiviral (DAA) regimen of glecaprevir (300mg)/pibrentasvir (120mg), a protease inhibitor and NS5A inhibitor respectively , provides key features for HCV treatment simplification.

Eligible participants (naïve pre-cirrhosis chronic HCV patients) will be randomized (1:2) to the standard or simplified monitoring arm and will receive treatment for 8 weeks.

One post treatment visit will be conducted 12 weeks after the final dose of study medication to evaluate the proportion of patients with undetectable HCV RNA at this timepoint (SVR12).

ReferenceCitation: Dore GJ, Feld JJ, Thompson A, Martinello M, Muir AJ, Agarwal K, Mullhaupt B, Wedemeyer H, Lacombe K, Matthews GV, Schultz M, Klein M, Hezode C, Mercade GE, Kho D, Petoumenos K, Marks P, Tatsch F, Dos Santos AGP, Gane E; SMART-C Study Group. Simplified monitoring for hepatitis C virus treatment with glecaprevir plus pibrentasvir, a randomised non-inferiority trial. J Hepatol. 2020 Mar;72(3):431-440. doi: 10.1016/j.jhep.2019.10.010. Epub 2019 Oct 23.

evidence: open (via free pdf)

repositories_institution: University of Zurich - Zurich Open Repository and Archive

location_facility: Center for HIV and Hepatogastroenterology

location_facility: New York University Langone Medical Center

location_facility: zibp - Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Imperial College Healthcare NHS Trust (St Mary's Hospital)

location_facility: CIM-Centrum fuer Interdisziplinaere Medizin GmbH

title: A Phase IIIb, Open-label, Multicentre, International Randomised Controlled Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir (300mg)/Pibrentasvir (120mg) in Chronic HCV Treatment naïve Patients Without Cirrhosis

ipd_sharing_description: No individual participant data will be shared. The results of the project will be presented at scientific meetings, and published in peer reviewed scientific literature. Sharing of data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We plan to make our results available to the community of scientists interested in recently acquired hepatitis C, community organisations representing the affected communities and participants. We also welcome collaboration with others who could make use of data and samples.

location_country:
Germany
New Zealand
United Kingdom
Australia
Switzerland
United States
Canada
France


type: EudraCT Number

title: Incidence of Squamous Cell Carcinoma and Other Skin Neoplasia in Subjects With Actinic Keratosis Treated With Ingenol Disoxate Gel 0.018% or 0.037%, or Vehicle Gel

summary:
One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial.

In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: LEO Pharma

location_country:
Germany
United Kingdom
United States
Spain
Canada
France

location_facility: Center for Dermatology Clinical Research, Inc.

location_facility: Contour Dermatology & Cosmetic Surgery Center

location_facility: Research Institute of the Southeast, LLC

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: AboutSkin Dermatology and DermSurgery, PC

location_facility: Suzanne Bruce and Associates, P.A., The Center for Skin Research

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

summary: The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Italy
Poland
Israel
Argentina
Norway
Australia
Romania
Netherlands
Switzerland
Belgium
United States
Spain
Chile
Canada
France

location_facility: Humanitas-U.O di Oncologia medica ed Ematologia

location_facility: Istituto Nazionale Tumori Fondazione Pascale

intervention_type: Biological

status_simplified: Ongoing


acronym: Study of LN-145 in the treatment of Patients with cervical cancer

lead_sponsor: Iovance Biotherapeutics, Inc.

summary: Prospective, multicenter, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (LN-145) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma

location_facility: University of Florida Health Cancer Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: University of South Florida H. Lee Moffitt Cancer Center and Research Institute

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: St. Joseph's Hospital and Medical Center Center For Women's Health

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: University of Oklahoma Health Sciences Center

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne - Centre Pluridisciplinaire d'Oncologie

status: Recruiting

title: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Recurrent, Metastatic or Persistent Cervical Carcinoma

source: euctr

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
Netherlands
Switzerland
United States
Spain
France

ipd_sharing: No


title: A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Primary Immune Thrombocytopenia

summary: The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia.

status: Completed

ReferenceType: result

ReferenceCitation: Newland AC, Sanchez-Gonzalez B, Rejto L, Egyed M, Romanyuk N, Godar M, Verschueren K, Gandini D, Ulrichts P, Beauchamp J, Dreier T, Ward ES, Michel M, Liebman HA, de Haard H, Leupin N, Kuter DJ. Phase 2 study of efgartigimod, a novel FcRn antagonist, in adult patients with primary immune thrombocytopenia. Am J Hematol. 2020 Feb;95(2):178-187. doi: 10.1002/ajh.25680. Epub 2019 Dec 10.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ipd_sharing: Undecided

lead_sponsor: argenx

sponsor_collaborators:
argenx
Quintiles, Inc.

location_country:
Germany
Poland
Hungary
United Kingdom
Austria
Belgium
Spain
Czechia
Ukraine
France

location_facility:
Valencia
Mont-Godinne
Ivano-Frankivsk
Paris
Berlin
Lublin
Brno
Wien
London
Bordeaux
Debrecen
Nyiregyhaza
Opole
A Coruna
Tubingen
Praha
Nikolaev
Vienna
Kaposvar
Gyula
Barcelona
Hanover
Uzhgorod
Budapest
Dnipro
Grenoble
Wroclaw
Pecs
Leuven
Madrid

status_simplified: Completed


summary: The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.

sponsor_collaborators:
Bristol-Myers Squibb
Janssen Biotech, Inc.

title: Phase 1/2 Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab Combined With Daratumumab in Participants With Advanced or Metastatic Solid Tumors

location_country:
Germany
Italy
Australia
Switzerland
United States
Spain
Canada
Puerto Rico
France


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.

ReferenceType: derived

ReferenceCitation: Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Ferrari MD, Reuter U, Goadsby PJ, Paiva da Silva Lima G, Mondal S, Wen S, Tenenbaum N, Pandhi S, Lanteri-Minet M, Stites T. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2022 Mar;93(3):254-262. doi: 10.1136/jnnp-2021-327480. Epub 2021 Nov 29.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

ReferenceCitation: Goadsby PJ, Reuter U, Lanteri-Minet M, Paiva da Silva Lima G, Hours-Zesiger P, Fernandes C, Wen S, Tenenbaum N, Kataria A, Ferrari MD, Klatt J. Long-Term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. 2021 Apr 28;96(22):e2724-35. doi: 10.1212/WNL.0000000000012029. Online ahead of print.

repository_institution: Leiden University - Leiden Repository

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Lanteri-Minet M, Goadsby PJ, Reuter U, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021 May;92(5):466-472. doi: 10.1136/jnnp-2020-324396. Epub 2021 Jan 5.

ReferenceCitation: Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.

oa_host_type: repository

repository_institution: King's College London - Research Portal

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: Elsevier

title: A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous 140 mg AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed 2-4 Prophylactic Treatments (LIBERTY)

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:
Finland
Germany
Italy
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
Czechia
France

ipd_sharing: Yes


lead_sponsor: AstraZeneca

summary: This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.

ReferenceCitation: Choueiri TK, Heng DYC, Lee JL, Cancel M, Verheijen RB, Mellemgaard A, Ottesen LH, Frigault MM, L'Hernault A, Szijgyarto Z, Signoretti S, Albiges L. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218. Erratum In: JAMA Oncol. 2020 Sep 1;6(9):1473.

publisher_dissemination: American Medical Association

ReferenceCitation: Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.

oa_host_type: closed

repositories_concat: closed

sponsor_collaborators:
AstraZeneca
Hutchinson MediPharma (HMP)

title: A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)

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

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

location_country:
Italy
Brazil
United States
Korea, Republic of
Ukraine
Russian Federation
France


acronym: TRACE

lead_sponsor: Actelion

summary: The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.

ReferenceCitation: Howard LS, Rosenkranz S, Frantz RP, Hemnes AR, Pfister T, Hsu Schmitz SF, Skara H, Humbert M, Preston IR. Assessing Daily Life Physical Activity by Actigraphy in Pulmonary Arterial Hypertension: Insights From the Randomized Controlled Study With Selexipag (TRACE). Chest. 2023 Feb;163(2):407-418. doi: 10.1016/j.chest.2022.08.2231. Epub 2022 Sep 8.

location_facility: Centro Hospitalar e Universitário de Coimbra, Serviço de Cardiologia

location_facility: Royal Hallamshire Hospital, Pulmonary Vascular Medicine

location_facility: University of Texas Health Science Center (San Antonio)

location_facility: Kantonsspital St. Gallen, Klinik für Pneumologie und Schlafmedizin

location_facility: The Royal Free Hospital, Cardiology Department

location_facility: Oslo University Hospital, dept of cardiology

location_facility: Medizinische Universität Innsbruck (MUI), Abt. für Pneumologie, Haus 2

location_facility: Tufts Medical Center, Pulmonary/Critical Care & Sleep

location_facility: Golden Jubilee National Hospital, Scottish Pulmonary Vascular Unit

location_facility: Krankenhaus der Elisabethinen, Servicestelle Klinische Studien

location_facility: Skåne University Hospital, VO Hjärt och Lungmedicin

location_facility: Vanderbilt University Medical Center, Care Medicine

location_facility: Universitaetsspital Zurich, Klinik für Pneumologie C HOER 11

location_facility: Universitätsklinikum Leipzig AöR, Abteilung Pneumologie

location_facility: Freeman Hospital, Cardiothoracic Department

location_facility: Duke University School of Medicine, Duke Pulmonary Vascular Disease center

location_facility: Sahlgrenska University Hospital, Gothenburg

location_facility: Katholisches Klinikum Lünen/Werne GmbH, Haus E

location_facility: CHRU de Lille - Hôpital Albert Calmette, Service de cardiologie

location_facility: University of Cincinnati, Heart, Lung and Vascular Institute

location_facility: Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin

location_facility: Hôpital Bicêtre, ervice de Pneumologie et Réanimation respiratoire

location_facility: University of Pennsylvania, Pulmonary Vascular Disease Program

location_facility: University of Nebraska Medical Center, Pulmonary, Critical Care & Sleep Medicine Division

location_facility: Papworth Hospital, Pulmonary Vascular Disease Unit

title: A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts

primary_purpose: Other

location_country:
Ireland
Germany
Portugal
Norway
United Kingdom
Sweden
Switzerland
Austria
United States
France


title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

summary: The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.

lead_sponsor: Gilead Sciences

sponsor_collaborators:
Gilead Sciences
Galapagos NV

location_country:
Germany
Italy
Hungary
United Kingdom
Austria
Belgium
United States
Canada
France

location_facility: Royal Devon and Exeter Hospital, Department of Gastroenterology

location_facility: Northwestern University Feinberg School of Medicine

location_facility: University of Louisville Clinical Trials Unit

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza

location_facility: University of Miami Crohn's and Colitis Center

location_facility: University of South Florida South Tampa Campus

location_facility: Bugát Pál Kórház, Gasztroenterológiai osztály

location_facility: Center for Interventional Endoscopy - Florida Hospital

location_facility: Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology

location_facility: John Hopkins Gastroenterology and Hepatology Services at the Green Spring Station Clinic

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: CHU Grenoble Alpes - Hopital Michallon (main office)

location_facility: CHU de Rennes - Hôpital Pontchaillou (main office)

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Toronto Digestive Disease Associates Inc.


acronym: Ixora-peds

lead_sponsor: Eli Lilly and Company

summary: The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

ReferenceCitation: Paller AS, Seyger MMB, Magarinos GA, Pinter A, Cather JC, Rodriguez-Capriles C, Zhu D, Somani N, Garrelts A, Papp KA; IXORA-PEDS Investigators. Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis: The IXORA-PEDS Randomized Clinical Trial. JAMA Dermatol. 2022 May 1;158(5):533-541. doi: 10.1001/jamadermatol.2022.0655. Erratum In: JAMA Dermatol. 2022 Aug 17;:null.

repository_institution: Radboud University - Radboud Repository

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

location_facility: University of North Carolina Dermatology and skin Cancer Cen

location_facility: Fundación Estudios Clínicos- Servicio de Dermatología

location_facility: Solutions Through Advanced Research, Inc.

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Universitair Medisch Centrum St Radboud Nijmegen

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Centre hospitalier universitaire Pellegrin

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: SZTE AOK Borgyogyaszati es Allergologiai Klinika

location_facility: Instituto de Neumonología y Dermatología

location_facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology

location_facility: SSM Health Cardinal Glennon Children's Hospital

location_facility: Hospital Univ. Dr. Jose Eleuterio Gonzalez

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

title: Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis

type: Other Identifier

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

location_country:
Germany
Poland
Hungary
Argentina
Netherlands
Mexico
United States
Spain
Czechia
Canada
Puerto Rico
Russian Federation
France


title: Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

acronym: PROMINENT

summary:
The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

nonfatal Myocardial Infarction (MI)
nonfatal ischemic stroke
coronary revascularization; or
Cardio Vascular (CV) death.

ReferenceCitation: Das Pradhan A, Glynn RJ, Fruchart JC, MacFadyen JG, Zaharris ES, Everett BM, Campbell SE, Oshima R, Amarenco P, Blom DJ, Brinton EA, Eckel RH, Elam MB, Felicio JS, Ginsberg HN, Goudev A, Ishibashi S, Joseph J, Kodama T, Koenig W, Leiter LA, Lorenzatti AJ, Mankovsky B, Marx N, Nordestgaard BG, Pall D, Ray KK, Santos RD, Soran H, Susekov A, Tendera M, Yokote K, Paynter NP, Buring JE, Libby P, Ridker PM; PROMINENT Investigators. Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk. N Engl J Med. 2022 Nov 24;387(21):1923-1934. doi: 10.1056/NEJMoa2210645. Epub 2022 Nov 5.

oa_colors: green other

evidence: open (via free article)

repository_institution: Imperial College London - Spiral

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Pradhan AD, Paynter NP, Everett BM, Glynn RJ, Amarenco P, Elam M, Ginsberg H, Hiatt WR, Ishibashi S, Koenig W, Nordestgaard BG, Fruchart JC, Libby P, Ridker PM. Rationale and design of the Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) study. Am Heart J. 2018 Dec;206:80-93. doi: 10.1016/j.ahj.2018.09.011. Epub 2018 Sep 29.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark);mediatum.ub.tum.de

lead_sponsor: Kowa Research Institute, Inc.

sponsor_collaborators:
Kowa Research Institute, Inc.
Brigham and Women's Hospital

location_country:
Germany
Poland
Argentina
Japan
Brazil
Czechia
Canada
France
Colombia
Slovakia
Hungary
Denmark
United States
Ukraine
India
Romania
Puerto Rico
United Kingdom
Netherlands
Mexico
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility: Centro de Investigacion Medico Asistencial S.A.S

location_facility: NZOZ Przychodnia Specjalistyczna H. Rudzki, A. Wittek

location_facility: CNE City Clin Hosp #8 of KCC Dept of Therapy Kharkiv MA of PGE of MOHU

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu"

location_facility: Morgan Medical Management & Consultants Inc.

location_facility: Med Center of Eurolab LLC Policlinic Outpatient Dept O.O.Bogomolets NMU

location_facility: SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU

location_facility: SHI "Perm Regional Hospital of War Veterans"

location_facility: Research Institute of the Carolinas, PLC

location_facility: NSIH "Departmental Hospital on Station Kemerovo of OJSC "Russian Railways"

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

location_facility: Central Arkansas Veterans Healthcare System

location_facility: HUJBB-UFPA - Hospital Universitário João de Barros Barreto - Universidade Federal do Pará

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Kernodle Clinic, Inc., Dept. of the Private Diagnostic Clinic, PLLC

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

location_facility: CI Dnipropetrovsk City Cl Hosp #9 of Dniprop Reg Council SI DMA of MOH of Ukr Ch of Endocrinology

location_facility: Kyiv CH on Railway Transport #2 of Branch Center of Healthcare Public Company Ukr Railway

location_facility: Dr. Nagy Laszlo Kardiologiai Maganrendeles

location_facility: Alta Pharmaceutical Research Center, Inc.

location_facility: State Institution LT Malaya Inst. of Ther. of AMS of Ukraine

location_facility: CI Cherkasy RH of Cherkasy Regional Council

location_facility: Synexus Polska Sp. z o.o. Oddział w Warszawie

location_facility: Lviv Communal 4th City Clinical Hospital

location_facility: Clínica de Endocrinologia e Metabologia Ltda.

location_facility: Lviv Reg St Clin Treatment - Diagnostic Endocrin Center, Dept of Polyclinic, D.Galytskyy Lviv NMU

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Railway Transport Kharkiv CH#1 of Healthcare Center Branch of PJSC Ukrainian Railway

location_facility: CEMEDIC - Centro de Especialidades Medicas

location_facility: South Shore Internal Medicine Associates

location_facility: S.C Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

location_facility: Chattanooga Research and Medicine (CHARM)

location_facility: Specjalistyczna Poradnia Kardiologiczna i Nadciśnienia Tętniczego

location_facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

location_facility: Center of Reconstructive & Restorative Medicine (University Clinic) of Odessa National Medical Uni

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: National Center For Geriatrics And Gerontology

location_facility: Katholisches Krankenhaus "St. Johann Nepomuk"

location_facility: Centro de Atención e Investigación en Factores de Riesgo Cardiovascular Omega S.C.

location_facility: Kardiologicka, interna a sonograficka amb. Kardio-Sanus, sro

location_facility: Veterans Affairs Ann Arbor Healthcare System

location_facility: NZOZ Osrodek Kardiologii Inwazyjnej -Ikardia

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

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

location_facility: Murmansk Regional Clinical Hospital named after Bayandin

location_facility: SIH "Saratov City Clinical Hospital # 2 n.a. V.I. Razumovskiy"

location_facility: Institute of Medical Sciences and SUM Hospital

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares S.C.

location_facility: SPSK Nr 7 SUM w Katowicach Gornoslaskie CM im. prof. Leszka Gieca

location_facility: Captain James A. Lovell Federal Health Care Center

location_facility: Public Central Hospital of Matto Ishikawa

location_facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.

location_facility: Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch

location_facility: LLC Treatment and Diagnostic Center Adonis Plus

location_facility: CPCLIN - Centro de Pesquisas Clínicas Ltda.

location_facility: Delmarva Heart Research Foundation, Inc.

location_facility: AA MRC LLC Ahmed Arif Medical Research Center

location_facility: Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

location_facility: BIH of Omsk region "Clinical Medico-Sanitary Unit # 9

location_facility: Nakakinen Clinic Medical Corporation Kensei-kai

location_facility: Iowa Diabetes and Endocrinology Research Center, PLC

location_facility: Nuevas tecnologías en Diabetes y Endocrinología

location_facility: Vinnytsia RC Highly Special.Endocr.Center Dept of Therapy #2 M.I. Pyrogov NMU

location_facility: KARDIOMED Janczska Kociwska Ostki PodckaRekrzSp

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Synexus Polska Sp. z o.o. Oddział we Wroclawiu

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky

location_facility: Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia

location_facility: Saint-Petersburg SBHI "City outpatient clinic #28"

location_facility: Cincinnati Veterans Affairs Medical Center

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: National Pirogov Memorial Medical University

location_facility: IPCC - Instituto de Pesquisa Clínica de Campinas

location_facility: Poradnia Kardiologiczna Jarosław Jurowiecki

location_facility: MC of PHEI Institute of General Practice - Family Medicine

location_facility: BC Diabetes As Operated by Dr. TG Elliott, Inc.

location_facility: Yaroslavl Regional Clinical Hospital of War Veterans

location_facility: Hospital Privado Centro Medico de Cordoba S.A

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: TSBIH "Krasnoyarsk Interdistrict Clinical Hospital of Emergency Medical Care n.a. N.S. Karpovich

location_facility: Centro de Pesquisa Médica Santa Maria Ltda.

location_facility: FSBI "Research Institute for Cardiology" of Siberian Branch RAMS

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: LMC Clinical Research dba Manna Research Inc. Mirabel

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: Applied Medical Informatics Research Inc.

location_facility: Centro de Investigacion Cardiovascular y Metabolica

location_facility: Sukromna interna a kardiologicka ambulancia

location_facility: SBIH of Novosibirsk Region "Clinical Emergency Hospital #2"

location_facility: Huntington Hospital - Research Department

location_facility: Clinique Médicale St-Louis (Recherche) inc d/b/a/ Centre de Recherche Saint-Louis

location_facility: CEDIC Centro de Investigaciones Clinicas

location_facility: Medical Center of Limited Liability Company Medical Center Concilium Medical

location_facility: Maestri e Kormann Consultoria Medico Científica LTDA

location_facility: Synexus Manchester Clinical Research Centre

location_facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

location_facility: Zentrum fuer Praevention und Rehabilitation

location_facility: SI V.P.Komisarenko Institute of E&M of NAMSU

location_facility: S.C. Diabmed Dr. Popescu Alexandrina S.R.L

location_facility: University Diabetes & Endocrine Consultants

location_facility: Synexus Scotland Clinical Research Centre

location_facility: University of Maryland School of Medicine

location_facility: Synexus Polska sp. z o.o. Oddzial w Poznaniu

location_facility: Shiga University of Medical Science Hospital

location_facility: LMC Clinical Research dba Manna Research Inc. Burlington North

location_facility: SPb SBIH "City Multy-field Hospital # 2"

location_facility: Neurologische Praxis Dr. Schoell & Kollegen

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: Ternopil City Municipal Hospital #2 Dept of Gastroenterology Ternopil I.Ya. Gorbachevskyi SMU

location_facility: MC of Subsidiary Production Unit Med Scient Pract Union Medbud of PJSc Holding Company Kyivmiskbud

location_facility: Z+P MED Egeszsegugyi, Kereskedelmi es Szolgaltato Bt.

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Novant Health - Heart and Vascular Institute

location_facility: Kalispell Regional Medical Center dba Glacier View Research Institute

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Clínica Paulista de Doenças Cardiovasculares Ltda.

location_facility: CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

location_facility: Stratton Veterans Affairs Medical Center - Albany

location_facility: Saul Vizel Professional Medicine Corporation

location_facility: LMC Clinical Research dba Manna Research Inc. Toronto

location_facility: Albert Schweitzer Ziekenhuis, Zwijndrecht

location_facility: OhioHealth Heart & Vascular Physicians (Heartcare, Inc.) - Athens

location_facility: Okinawa Tokushukai Chubu Tokushukai Hospital

location_facility: Northeast Clinical Research of San Antonio

location_facility: Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Kardiologii lek. med. Krzysztof Cymerman

location_facility: Community Hospital of Anderson and Madison County, Inc.

location_facility: CI Ye.Ye.Karabelesh Kherson City Clinical Hosp.

location_facility: TSHI "Altay Territorial Cardiologocal dispensary"

location_facility: Centro Cardiovascular Aristides Sotomayor Santa Lucia S.A.S. - IPS ASTALUC S.A.S. IPS

location_facility: Tokushukai Kishiwada Tokushukai Hospital

location_facility: Fundación Oftalmológica de Santander - FOSCAL

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi

location_facility: Synexus Helderberg Clinical Research Centre

location_facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas

location_facility: Synexus SA - Stanza Clinical Research Centre

location_facility: Centro de Investigacion Medica de Occidente, S.C.

location_facility: Institute of Cardiovascular Diseases Madras Medical Mission

location_facility: L2IP - Instituto de Pesquisas Clínicas Ltda.

location_facility: Eurolatino Natal Pesquisas Médicas Ltda.

location_facility: Department of Medical Services and Rehabilitation of State Joint Stock Holding Company Artem

location_facility: Belgyogyaszati es Kardiologiai Maganrendelo

location_facility: SBIH of Novosibirsk region "City Clinical Hospital # 19"

location_facility: Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

location_facility: Solano y Terront Servicios Médicos Ltda.

location_facility: Instituto de Diabetes, Obesidad y Nutrición S.C.

location_facility: Providence Veteran Administration Medical Center

location_facility: Louis Stokes Cleveland Dept of VA Medical Center

location_facility: Centro de Pesquisa Clínica Maimônides - Maimônides Day Hospital

location_facility: Institut fuer klinische Forschung und Entwicklung Berlin GmbH

location_facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: CHI Kharkiv City Student Hosp Therap dept Nat Pharm Univer

location_facility: Railway Transport Kharkiv CH #1 of Healthcare Center Branch of PJSC Ukr Railway

location_facility: CMI CCH#3 Dep of Ther# w the beds of card profile HSEI of UBSMU

location_facility: Zhytomyr regional clinical hospital n.a. O.F. Gerbachevskyy

location_facility: Hospital Regional Universitario de Malaga

location_facility: FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

location_facility: Spitalul Clinic de Urgenta "Sfantul Pantelimon"

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 KCC

location_facility: GP Dr. Haggenmiller, PD Dr. Michael Jeserich

location_facility: Fortis Flight Lieutenant Rajan Dhall Hospital

location_facility: ZKS-Südbrandenburg -center for clinical studies Südbrandenburg GmbH

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes S.A de C.V

location_facility: Synexus SA Watermeyer Clinical Research Centre

location_facility: AMH Feasterville Family Health Care Center

location_facility: MUDr. Jan KVASNICKA CSc. Angiologie kardiologie a interna

location_facility: Diabetes and Thyroid Center of Fort Worth

location_facility: FSBI North-West Federal Medical Research Center n.a. V.A. Almazov of MoH RF

location_facility: Shri B. D. Mehta Mahavir Heart Institute

location_facility: Fundación Centro de Investigaciones Biomédicas Riescard

location_facility: IMC - Instituto de Moléstias Cardiovasculares Tatuí

location_facility: FSBI "Scientific-research Institute for Complex Problems of cardiovascular disease"

location_facility: FSBSI "Scientific Research Institute of Therapy and Preventive Medicine"

location_facility: Investigacion En Salud Y Metabolismo S.C.

location_facility: Dr. Uwe Böckmann / Birgit Jacobs - Diabeteszentrum Neumünster

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska dr n. med. Agnieszka Karczmarczyk Specjalista Chorob

location_facility: Santa Rosa Cardiology Medical Group, Inc.

location_facility: CI Zapor CCH#10 SI ZMA PGE Ch of therapy clin pharmacol & endocrin

location_facility: SBIH of Arkhangelsk region " First City Clinical hospital n.a. E. E. Volosevich"

location_facility: VA Greater Los Angeles Healthcare System

location_facility: King Edward Memorial Hospital Research Centre

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Supe Heart & Diabetes Hospital & Research Centre

location_facility: Ryubokai Higashi Diabetes and Cardiovascular Clinic

location_facility: SBIH of Moscow "City Clinical Hospital n.a.Bakhrushinykh"

location_facility: SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov" of the MoH of the RF

location_facility: MC Doctor Alex Dept of General Practice-Family Medicine Kharkiv MA of PGE

location_facility: SI V.P.Komisarenko Institute of Endocrinology and Metabolism of NAMSU

location_facility: CI Sumy City Clinical Hospital #1 Dept of Therapy Sumy SU Med Inst

location_facility: Miyanosawa Clinic of Internal Medicine and Cardiology

location_facility: Nemocnica s poliklinikou sv. Barbory Roznava a.s.

location_facility: Jacksonville Center for Clinical Research

location_facility: SEIHPE "Ural SMA of RosZdrav" b.o. LLC "City Hospital #41"

location_facility: Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud

location_facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Schnitzler Cardiovascular Consultants (SCC), PLLC

location_facility: State Budgetary Healthcare Institution Clinical Medical Sani

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. Jana Pawla II

location_facility: Royal Alexandra Hospital, CK Hui Heart Centre

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Synexus Birmingham Clinical Research Centre

location_facility: Joanne F. Liutkus Medicine Professional Corporation

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Toyukai Yutenji Medical Clinic (Yutenji Naika)

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: RCI Chernivtsi Regional Endocrinology Center Policlinic Dept SHEI of UBSMU

location_facility: Ahmedabad Bariatrics and Cosmetics Pvt Ltd.

location_facility: Gemeinschaftspraxis fuer innere Medizin und Diabetologie

location_facility: Transcarpathian Regional Clinical Cardiology Dispansery

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Instituto de Investigaciones Clinicas San Nicolas

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft.- Gyula DRS

location_facility: Centro de Investigacion Clinica del Pacifico, S.A. de C.V.

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: University of North Texas Health Science Center

location_facility: Ivano-Frankivsk CCH Dept of Therapy #1 SHEI Ivano-Frankivsk NMU

location_facility: Kardiologicka ambulance MUDr. Ferkl s.r.o.

location_facility: SI National Scientific Centre of Radiation Medicine of NAMSU

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Texas Health Research & Education Institute

location_facility: VA Nebraska-Western Iowa Health Care System

location_facility: Diagnostic Consultative Center II - Sofia OOD

location_facility: Clinique des maladies Lipidiques de Quebec

location_facility: CI Ivano-Frankivsk Reg Cl Card Center Dept of Chronic Ischemic Heart Dis SHEI Ivano-Frank NMU

location_facility: FSHI "MSU of MoIA of RF of Kemerovo Region"

location_facility: Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

location_facility: CMI Dr. Stolea T. Violeta - Medic specialist diabet zaharat, nutritie si boli metabolice

location_facility: Phoenix Veterans Adminstration Health Care System

location_facility: Clinical Research Institute of Arizona, LLC

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: FSBI "Central Clinical Hospital with Polyclinic of the Department for Presidential Affairs of the RF

location_facility: SBIH of Perm territory " City Clinical Hospital # 2 n.a. Fedor Khristoforovich Gral"

location_facility: SI NSC M.D. Strazhesko Institute of Cardiology of NAMSU

location_facility: Hospital Interzonal General de Agudos Dr Jose Penna

location_facility: Hometown Urgent Care & Occupational Health

location_facility: Clearwater Cardiovascular & Interventional Consultants

location_facility: Cline Research Center (Leite PS Consultoria Medica LTDA)

location_facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

location_facility: Regional CH Dept of Endocrinology SHEI Ivano-Frankivsk NMU

location_facility: Southern New Hampshire Diabetes and Endocrinology

location_facility: SBHI "City Polyclinic #2 of Healthcare department of city of Moscow"

location_facility: Houston Methodist Research Institute - CCAT Pearland

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: KCCC of Endocr Dept of General Endocrine Pathology O. O. Bogomolets NMU

location_facility: Iwate Medical University Uchimaru Medical Center Hospital

location_facility: National Cerebral and Cardiovascular Center

location_facility: Inst. Privado de Inv. Clinicas de Cordoba


title: Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

summary: This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 [NCT02217475] or the AURORA study [NCT03028740].

lead_sponsor: Tobira Therapeutics, Inc.

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

location_facility: Johns Hopkins University School of Medicine

location_facility: Universitaetsklinikum Heidelberg - Innere Medizin IV

location_facility: Mercy Medical Center - Baltimore, Maryland

location_facility: Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital

location_facility: Consultants for Clinical Research - Cincinnati

location_facility: University of California, San Diego (UCSD) - Medical Center

location_facility: Central Adelaide Local Health Network Inc - Royal Adelaide Hospital

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.

location_facility: Virginia Commonwealth University Medical College of Virginia

location_facility: The University of Texas - Health Science Center & Medical School at Houston

location_facility: Charite - University Hospital Berlin - Campus Virchow - Hospital

location_facility: Royal Brisbane Hospital and Women's Hospital

location_facility: AOU Policlinico Paolo Giaccone di Palermo

location_facility: Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik

location_facility: Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: University of Buffalo - Erie County Medical Center

location_facility: University Hospital Giessen and Marburg GmbH

location_facility: University of Miami - Schiff Center for Liver Diseases

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Digestive Health Specialists of the Southeast - Dothan


title: Predicting Acute-on-Chronic Liver Failure in Cirrhosis (PREDICT) Study

acronym: PREDICT

summary: The aim of this study is to assess prospectively the critical period prior to the development of Acute-on-Chronic Liver Failure (ACLF) (1), to uncover mechanistic and pathophysiological processes associated with the development and clinical course of ACLF (2) and to identify the precipitating events of ACLF (3).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jansen C, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Jarcuska P, Steib C, Reiberger T, Acevedo J, Gatti P, Shawcross DL, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Danielsen KV, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Kani HT, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia-Lopez E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Praktiknjo M, Curto A, Pitarch C, Putignano A, Moreno E, Bernal W, Aguilar F, Claria J, Ponzo P, Vitalis Z, Zaccherini G, Balogh B, Gerbes A, Vargas V, Alessandria C, Bernardi M, Gines P, Moreau R, Angeli P, Jalan R, Arroyo V; PREDICT STUDY group of the EASL-CLIF CONSORTIUM. PREDICT identifies precipitating events associated with the clinical course of acutely decompensated cirrhosis. J Hepatol. 2021 May;74(5):1097-1108. doi: 10.1016/j.jhep.2020.11.019. Epub 2020 Nov 20.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Elsevier - Scopus

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: LIRIAS (KU Leuven);Pure (Denmark);UCL Discovery;archive.ugent.be;boris.unibe.ch;ddd.uab.cat;irua;scholarlypublications.universiteitleiden.nl

ReferenceCitation: Trebicka J, Fernandez J, Papp M, Caraceni P, Laleman W, Gambino C, Giovo I, Uschner FE, Jimenez C, Mookerjee R, Gustot T, Albillos A, Banares R, Janicko M, Steib C, Reiberger T, Acevedo J, Gatti P, Bernal W, Zeuzem S, Zipprich A, Piano S, Berg T, Bruns T, Bendtsen F, Coenraad M, Merli M, Stauber R, Zoller H, Ramos JP, Sole C, Soriano G, de Gottardi A, Gronbaek H, Saliba F, Trautwein C, Ozdogan OC, Francque S, Ryder S, Nahon P, Romero-Gomez M, Van Vlierberghe H, Francoz C, Manns M, Garcia E, Tufoni M, Amoros A, Pavesi M, Sanchez C, Curto A, Pitarch C, Putignano A, Moreno E, Shawcross D, Aguilar F, Claria J, Ponzo P, Jansen C, Vitalis Z, Zaccherini G, Balogh B, Vargas V, Montagnese S, Alessandria C, Bernardi M, Gines P, Jalan R, Moreau R, Angeli P, Arroyo V; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct pathophysiology. J Hepatol. 2020 Oct;73(4):842-854. doi: 10.1016/j.jhep.2020.06.013. Epub 2020 Jul 13.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

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

repository_institution: Library of the Hungarian Academy of Sciences - Repository of the Academy's Library

location_country:
Germany
Italy
Portugal
Slovakia
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
Spain
Turkey
France

location_facility: Pavol Jozef Sfarik University Kosice/Roosevelt Hospital Bystrica

location_facility: Hospital Clinic y Provencial de Barcelona

location_facility: Derriford Hospital, Plymouth Hospitals Trust


lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

summary: This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.

location_facility:
Teva Investigational Site 58299
Teva Investigational Site 51282
Teva Investigational Site 14655
Teva Investigational Site 37081
Teva Investigational Site 53399
Teva Investigational Site 58282
Teva Investigational Site 51283
Teva Investigational Site 50454
Teva Investigational Site 14641
Teva Investigational Site 32680
Teva Investigational Site 51291
Teva Investigational Site 14626
Teva Investigational Site 32671
Teva Investigational Site 58283
Teva Investigational Site 14652
Teva Investigational Site 14650
Teva Investigational Site 53406
Teva Investigational Site 14639
Teva Investigational Site 14638
Teva Investigational Site 14628
Teva Investigational Site 32675
Teva Investigational Site 80134
Teva Investigational Site 14630
Teva Investigational Site 53400
Teva Investigational Site 58284
Teva Investigational Site 51281
Teva Investigational Site 80131
Teva Investigational Site 58303
Teva Investigational Site 53402
Teva Investigational Site 32673
Teva Investigational Site 51280
Teva Investigational Site 31219
Teva Investigational Site 58291
Teva Investigational Site 54148
Teva Investigational Site 14629
Teva Investigational Site 53408
Teva Investigational Site 51285
Teva Investigational Site 58288
Teva Investigational Site 14636
Teva Investigational Site 58304
Teva Investigational Site 32676
Teva Investigational Site 14627
Teva Investigational Site 50461
Teva Investigational Site 58300
Teva Investigational Site 14624
Teva Investigational Site 37082
Teva Investigational Site 80135
Teva Investigational Site 14653
Teva Investigational Site 54150
Teva Investigational Site 14619
Teva Investigational Site 14648
Teva Investigational Site 53407
Teva Investigational Site 51284
Teva Investigational Site 58290
Teva Investigational Site 31217
Teva Investigational Site 32677
Teva Investigational Site 14622
Teva Investigational Site 14643
Teva Investigational Site 52116
Teva Investigational Site 35228
Teva Investigational Site 80129
Teva Investigational Site 58293
Teva Investigational Site 14644
Teva Investigational Site 54151
Teva Investigational Site 58294
Teva Investigational Site 32679
Teva Investigational Site 35229
Teva Investigational Site 58289
Teva Investigational Site 58287
Teva Investigational Site 14647
Teva Investigational Site 11134
Teva Investigational Site 58301
Teva Investigational Site 32670
Teva Investigational Site 51287
Teva Investigational Site 32682
Teva Investigational Site 80130
Teva Investigational Site 58298
Teva Investigational Site 50459
Teva Investigational Site 58297
Teva Investigational Site 14632
Teva Investigational Site 14625
Teva Investigational Site 50453
Teva Investigational Site 51286
Teva Investigational Site 14640
Teva Investigational Site 80133
Teva Investigational Site 14633
Teva Investigational Site 14621
Teva Investigational Site 53404
Teva Investigational Site 58292
Teva Investigational Site 51288
Teva Investigational Site 50458
Teva Investigational Site 58295
Teva Investigational Site 51289
Teva Investigational Site 14645
Teva Investigational Site 50460
Teva Investigational Site 14631
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title: An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

location_country:
Germany
Poland
Hungary
Israel
Romania
Belgium
United States
Spain
Czechia
Canada
Ukraine
Russian Federation
France


acronym: LIMMITLESS

lead_sponsor: AbbVie

summary: The purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.

ReferenceCitation: Papp KA, Lebwohl MG, Puig L, Ohtsuki M, Beissert S, Zeng J, Rubant S, Sinvhal R, Zhao Y, Soliman AM, Alperovich G, Leonardi C. Long-term efficacy and safety of risankizumab for the treatment of moderate-to-severe plaque psoriasis: interim analysis of the LIMMitless open-label extension trial beyond 3 years of follow-up. Br J Dermatol. 2021 Dec;185(6):1135-1145. doi: 10.1111/bjd.20595. Epub 2021 Sep 21.

repositories_concat: PubMed Central;ddd.uab.cat

repositories_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

publisher_dissemination: Oxford University Press

location_facility: Southern California Dermatology /ID# 154006

location_facility: The Dermatology Center PSC - New Albany /ID# 154075

location_facility: National Hospital Organization Sagamihara National Hospital /ID# 153867

location_facility: Modern Research Associates, PLLC /ID# 154043

location_facility: Icahn School of Medicine at Mount Sinai /ID# 154129

location_facility: Universitaetsklinikum Erlangen /ID# 154093

location_facility: Progressive Clinical Research /ID# 154149

location_facility: Advanced Medical Research, PC /ID# 153999

location_facility: The Jikei University Hospital /ID# 154080

location_facility: The South Bend Clinic Center /ID# 154147

location_facility: Osaka Metropolitan University Hospital /ID# 153869

location_facility: Bakersfield Derma & Skin Cance /ID# 154008

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 169415

location_facility: Nagasaki University Hospital /ID# 170219

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 153884

location_facility: Wilmington Dermatology Center /ID# 154109

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 153486

location_facility: Dermatology Specialists, Inc /ID# 153984

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 154092

location_facility: Michigan Center for Skin Care Research /ID# 153986

location_facility: Nagoya City University Hospital /ID# 153866

location_facility: Klinische Forschung Schwerin GmbH /ID# 154291

location_facility: Northshore University Health System Dermatology Clinical Trials Unit /ID# 154011

location_facility: Derm Clin Res Ctr San Antonio /ID# 153978

location_facility: Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 153917

location_facility: Nihon University Itabashi Hospital /ID# 154081

location_facility: Suzanne Bruce and Associates-Houston /ID# 154026

location_facility: Dermatology Research Institute Inc. /ID# 153850

location_facility: KonKuk University Medical Center /ID# 153483

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 153882

location_facility: Kaiser Permanente Los Angeles /ID# 154079

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 154111

location_facility: Huntington Medical Foundation /ID# 154002

location_facility: Oregon Dermatology and Research Center /ID# 153982

location_facility: Coastal Clinical Research Center of the Carolinas /ID# 154112

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 154293

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153915

location_facility: CCA Braga - Hospital de Braga /ID# 156323

location_facility: University of Alabama at Birmingham - Main /ID# 153983

location_facility: Universitaetsklinikum Tuebingen /ID# 153912

location_facility: Rush University Medical Center /ID# 154099

location_facility: Center for Dermatology Clinical Research /ID# 154009

location_facility: Oregon Medical Res Center PC /ID# 154003

location_facility: Sahlgrenska University Hospital /ID# 154132

location_facility: Klinische Forschung Hamburg GmbH /ID# 154290

location_facility: Minnesota Clinical Study Center /ID# 154015

location_facility: The Guenther Dermatology Research Centre /ID# 153841

location_facility: Dermatology Research Associates /ID# 153977

location_facility: CHU Toulouse - Hopital Larrey /ID# 153951

location_facility: DermaKiel Allergie und Haut Centrum /ID# 201316

location_facility: Seoul National University Bundang Hospital /ID# 153491

location_facility: York Dermatology Clinic and Research Centre /ID# 153860

location_facility: Centre de Recherche dermatologique du Quebec Metropolitain /ID# 153856

location_facility: ISA Interdisciplinary Study Association GmbH /ID# 153907

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 153906

location_facility: Hospital Universitario Infanta Leonor /ID# 154121

location_facility: Eastern Canada Cutaneous Resea /ID# 153870

location_facility: Centro de Dermatologia de Monterrey /ID# 153881

location_facility: Paddington Testing Co., Inc. /ID# 154022

location_facility: Forest Hills Dermatology Group /ID# 154113

location_facility: Medical Corporation Kojinkai Sapporo Skin Clinic /ID# 154083

location_facility: Hokkaido University Hospital /ID# 154285

location_facility: DermResearchCenter of New York, Inc. /ID# 154012

location_facility: Paratus Clinical Research Woden /ID# 154307

location_facility: Total Skin and Beauty Derm Ctr /ID# 154000

location_facility: UNISON Center for Clinical Tri /ID# 153979

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 153916

location_facility: Korea Universtiy Guro Hospital /ID# 153490

location_facility: Hamamatsu University Hospital /ID# 170132

location_facility: Center for Clinical Studies - Houston (Binz) /ID# 154005

location_facility: Progressive Medical Research /ID# 154027

location_facility: Iwate Medical University Hospital /ID# 170843

location_facility: The Centre for Clinical Trials /ID# 153871

location_facility: Leavitt Medical Associates of Florida /ID# 154046

location_facility: Seoul National University Hospital /ID# 153484

location_facility: Universitaetsklinikum Muenster /ID# 153895

location_facility: Medizinische Universitaet Wien /ID# 154302

location_facility: Pusan National University Hospital /ID# 153485

location_facility: Jichi Medical University Hospital /ID# 154286

location_facility: Bellaire Dermatology Associates /ID# 153987

location_facility: CHP, EPE- Hospital Geral de Sa /ID# 153464

location_facility: North Eastern Health Specialists /ID# 154309

location_facility: Gachon University Gil Medical Center /ID# 153489

location_facility: California Dermatology and Research Institute /ID# 154007

location_facility: Coastal Carolina Research Center /ID# 153992

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 153462

location_facility: Universitaetsmedizin Goettingen /ID# 154091

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 153467

location_facility: Taipei Medical University Shuang Ho Hospital /ID# 154134

location_facility: Uniwersyteckie Centrum Kliniczne /ID# 153471

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 153465

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 202490

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 153896

location_facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 156319

location_facility: Chonnam National University Hospital /ID# 153488

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 153948

location_facility: Universitaetsklinik Heidelberg /ID# 153910

location_facility: Dartmouth-Hitchcock Medical Center /ID# 154095

location_facility: Austin Dermatology Associates /ID# 154042

location_facility: Universitaetsklinikum Leipzig /ID# 153909

location_facility: St George Dermatology & Skin Cancer Centre /ID# 154308

location_facility: Hospital General Universitario de Valencia /ID# 154126

location_facility: National Taiwan University Hospital /ID# 154136

location_facility: ActivMed Practices and Research, LLC. /ID# 154044

location_facility: IMTR - Grand Hopital de Charleroi /ID# 154298

location_facility: Hospital Santa Creu i Sant Pau /ID# 154125

location_facility: Tokyo Medical University Hospital /ID# 153874

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 153842

location_facility: KO-MED Centra Kliniczne Lublin /ID# 153469

location_facility: Karolinska University Hospital Solna /ID# 154131

location_facility: Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 154289

location_facility: CMS3 Company for Medical Study /ID# 201318

location_facility: High-Med Przychodnia Specjalistyczna /ID# 153468

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 153892

location_facility: Dermatology Associates of Seattle /ID# 153988

location_facility: National Cheng Kung University Hospital /ID# 154135

location_facility: Synexus Clinical Research US, Inc. /ID# 154127

location_facility: Great Lakes Research Group, Inc. /ID# 153998

location_facility: Northwestern University Feinberg School of Medicine /ID# 153974

location_facility: Yokohama City University Hospital /ID# 168831

location_facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 153868

location_facility: Psoriasis Treatment Center of Central New Jersey /ID# 154001

location_facility: Epiphany Dermatology of Kansas LLC /ID# 153993

location_facility: NW Arkansas Clinical Trials Center /ID# 154014

location_facility: Windsor Clinical Research, Inc /ID# 153877

location_facility: Universitaetsklinikum Frankfurt /ID# 153891

location_facility: Yamaguchi University Hospital /ID# 156322

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153473

location_facility: The Indiana Clinical Trials Center /ID# 153976

location_facility: Virginia Clinical Research, Inc. /ID# 154016

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 153463

location_facility: New England Research Associates, LLC /ID# 154004

location_facility: Florida Academic Centers Research /ID# 154045

location_facility: North Bay Dermatology Centre /ID# 153845

location_facility: Dermatology Consulting Service /ID# 154010

location_facility: Fukushima Medical University Hospital /ID# 153873

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 154089

location_facility: Dermatology Ottawa Research Centre /ID# 153862

location_facility: Japan Organization of Occupational Health and Society Kanto Rosai Hospital /ID# 169172

location_facility: Kansai Medical University Hospital /ID# 170884

location_facility: Massachusetts General Hospital /ID# 153990

location_facility: St.Luke's International Hospital /ID# 153863

location_facility: Nippon Medical School Hospital /ID# 154084

location_facility: Center for Clinical Studies - Webster TX /ID# 154150

location_facility: MUDr. Blanka Havlickova - dermatovenerologie /ID# 153888

location_facility: Juntendo University Hospital /ID# 200292

title: A Multicenter, Open Label Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS)

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

location_country:
Finland
Germany
Poland
Portugal
Australia
Japan
Sweden
Austria
Belgium
Mexico
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France


lead_sponsor: Pfizer

summary: A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease

ReferenceCitation: Howard J, Ataga KI, Brown RC, Achebe M, Nduba V, El-Beshlawy A, Hassab H, Agodoa I, Tonda M, Gray S, Lehrer-Graiwer J, Vichinsky E. Voxelotor in adolescents and adults with sickle cell disease (HOPE): long-term follow-up results of an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2021 May;8(5):e323-e333. doi: 10.1016/S2352-3026(21)00059-4. Epub 2021 Apr 7.

ReferenceCitation: Minniti CP, Knight-Madden J, Tonda M, Gray S, Lehrer-Graiwer J, Biemond BJ. The impact of voxelotor treatment on leg ulcers in patients with sickle cell disease. Am J Hematol. 2021 Apr 1;96(4):E126-E128. doi: 10.1002/ajh.26101. Epub 2021 Feb 19. No abstract available.

ReferenceCitation: Vichinsky E, Hoppe CC, Ataga KI, Ware RE, Nduba V, El-Beshlawy A, Hassab H, Achebe MM, Alkindi S, Brown RC, Diuguid DL, Telfer P, Tsitsikas DA, Elghandour A, Gordeuk VR, Kanter J, Abboud MR, Lehrer-Graiwer J, Tonda M, Intondi A, Tong B, Howard J; HOPE Trial Investigators. A Phase 3 Randomized Trial of Voxelotor in Sickle Cell Disease. N Engl J Med. 2019 Aug 8;381(6):509-519. doi: 10.1056/NEJMoa1903212. Epub 2019 Jun 14.

oa_host_type: publisher

ReferenceCitation: Metcalf B, Chuang C, Dufu K, Patel MP, Silva-Garcia A, Johnson C, Lu Q, Partridge JR, Patskovska L, Patskovsky Y, Almo SC, Jacobson MP, Hua L, Xu Q, Gwaltney SL 2nd, Yee C, Harris J, Morgan BP, James J, Xu D, Hutchaleelaha A, Paulvannan K, Oksenberg D, Li Z. Discovery of GBT440, an Orally Bioavailable R-State Stabilizer of Sickle Cell Hemoglobin. ACS Med Chem Lett. 2017 Jan 23;8(3):321-326. doi: 10.1021/acsmedchemlett.6b00491. eCollection 2017 Mar 9.

license: publisher-specific-oa

license_normalized: publisher-specific

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: American Chemical Society

location_country:
Italy
Jamaica
United Kingdom
Netherlands
Lebanon
United States
Kenya
Turkey
Oman
Canada
Egypt
France


acronym: Basket Study

lead_sponsor: Rhythm Pharmaceuticals, Inc.

summary: The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight, hunger assessments, and other factors in participants with rare genetic disorders of obesity.

ReferenceCitation: Meyer JR, Krentz AD, Berg RL, Richardson JG, Pomeroy J, Hebbring SJ, Haws RM. Kidney failure in Bardet-Biedl syndrome. Clin Genet. 2022 Apr;101(4):429-441. doi: 10.1111/cge.14119.

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Synexus Clinical Research US, Inc. - Primary Care Associates, PC

location_facility: Synexus Clinical Research US, Inc. - Akron

location_facility: University of Florida College of Medicine

location_facility: Synexus Clinical Research US, Inc. - Chicago

location_facility: Synexus Clinical Research US, Inc. - St. Petersburg

location_facility: Edmond and Lily Safra Children's Hospital

location_facility: Synexus Clinical Research US, Inc. - Cincinnati

location_facility: Synexus Clinical Research US, Inc. - Phoenix Southeast

location_facility: Synexus Clinical Research US, Inc. - San Antonio

location_facility: Hopital Trousseau - Nutrition et Gastroentérologie

location_facility: Service de pédiatrie CHU de la Réunion - Hôpital Félix Guyon

location_facility: Synexus Clinical Research US, Inc. - Columbus

location_facility: Synexus Clinical Research US, Inc. - Simon Williamson Clinic, PC

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Anschutz Health and Wellness Center University of Colorado Anschutz Medical Campus

location_facility: Synexus Clinical Research US, Inc. - Plano

location_facility: Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

location_facility: Precision Medicine for Obesity Research: Gastroenterology & Hepatology Mayo Clinic

location_facility: Division of Endocrinology and Diabetes Children's National Hospital

location_facility: Vanderbilt University School of Medicine

title: Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity

location_country:
Germany
Israel
United Kingdom
Netherlands
United States
Spain
Greece
Canada
France


title: Phase 1 Open-label, Multicenter Study of MK-1454 Administered by Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab for Patients With Advanced/Metastatic Solid Tumors or Lymphomas

summary:
The purpose of this study is to identify a maximum tolerated dose (MTD) or maximum administered dose (MAD) of ulevostinag alone and of ulevostinag in combination with pembrolizumab in participants with advanced/metastatic solid tumors or lymphomas in Part 1, and to evaluate the safety and efficacy of ulevostinag via intratumoral (IT) injection in combination with pembrolizumab in selected solid tumors in Part 2.

Ulevostinag will be administered IT; pembrolizumab (pembro) will be administered via intravenous (IV) infusion. In Part 1, participants will be allocated to one of three treatment arms: ulevostinag monotherapy (cutaneous/subcutaneous [cut/subcut] lesions), ulevostinag +pembro (cut/subcut lesions), or ulevostinag +pembro (visceral lesions).

In Part 2, participants with head and neck squamous cell carcinoma (HNSCC) who are anti-programmed cell death-protein 1 or anti-programmed cell death-ligand 1 (anti-PD-1/PD-L1) refractory or with anti-PD-1/PD-L1 treatment (TrT)-naïve triple-negative breast cancer (TNBC) or with anti-PD-1/PD-L1 TrT-naïve solid tumors with liver metastases/lesions will receive ulevostinag via IT injection at the RP2D determined in Part 1 PLUS pembrolizumab via IV infusion for up 35 cycles (up approximately 2 years).

ReferenceCitation: Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.

publisher_dissemination: MDPI

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
France
United Kingdom
United States
Korea, Republic of
Israel

location_facility: Mary Crowley Cancer Research Center ( Site 0001)

location_facility: The Royal Marsden Foundation Trust ( Site 0031)

location_facility: University of California San Francisco ( Site 0007)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0032)


lead_sponsor: Millennium Pharmaceuticals, Inc.

summary: The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal GvHD in participants who have undergone allo-HSCT.

ReferenceCitation: Floisand Y, Schroeder MA, Chevallier P, Selleslag D, Devine S, Renteria AS, Mohty M, Yakoub-Agha I, Chen C, Parfionovas A, Quadri S, Jansson J, Akbari M, Chen YB. A phase 2a randomized clinical trial of intravenous vedolizumab for the treatment of steroid-refractory intestinal acute graft-versus-host disease. Bone Marrow Transplant. 2021 Oct;56(10):2477-2488. doi: 10.1038/s41409-021-01356-0. Epub 2021 Jun 9.

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

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central
digitalcommons.wustl.edu

location_facility: Oslo Universitetssykehus - Rikshospitalet

title: An Open-Label, Dose-Finding Study of Vedolizumab IV for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Patients Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

location_country:
France
Norway
Belgium
United States
Sweden


summary: The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs versus standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC).

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

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

title: An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma

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

More information provided by Eli Lilly and Company

location_country:
France
United Kingdom
Australia
Belgium
United States
Spain
Taiwan
Israel


title: The European Paediatric Network for Haemophilia Management and the PedNet Haemophilia Registry

acronym: PedNet

summary:
Rationale:

Haemophilia is a rare disease; to improve knowledge international collaboration is needed. Well-defined clinical data will be collected from complete cohorts in order to prevent selection bias.

Objective:

To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous (treatment-related) determinants of inhibitor development and long term outcome.

ReferenceCitation: van den Berg HM, Gouw SC, van der Bom JG. Factor VIII products and inhibitors in severe hemophilia A. N Engl J Med. 2013 Apr 11;368(15):1457. doi: 10.1056/NEJMc1301995. No abstract available.

ReferenceCitation: Gouw SC, van den Berg HM, Fischer K, Auerswald G, Carcao M, Chalmers E, Chambost H, Kurnik K, Liesner R, Petrini P, Platokouki H, Altisent C, Oldenburg J, Nolan B, Garrido RP, Mancuso ME, Rafowicz A, Williams M, Clausen N, Middelburg RA, Ljung R, van der Bom JG; PedNet and Research of Determinants of INhibitor development (RODIN) Study Group. Intensity of factor VIII treatment and inhibitor development in children with severe hemophilia A: the RODIN study. Blood. 2013 May 16;121(20):4046-55. doi: 10.1182/blood-2012-09-457036. Epub 2013 Apr 3.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Carcao MD, van den Berg HM, Ljung R, Mancuso ME; PedNet and the Rodin Study Group. Correlation between phenotype and genotype in a large unselected cohort of children with severe hemophilia A. Blood. 2013 May 9;121(19):3946-52, S1. doi: 10.1182/blood-2012-11-469403. Epub 2013 Mar 12.

ReferenceCitation: Clausen N, Petrini P, Claeyssens-Donadel S, Gouw SC, Liesner R; PedNet and Research of Determinants of Inhibitor development (RODIN) Study Group. Similar bleeding phenotype in young children with haemophilia A or B: a cohort study. Haemophilia. 2014 Nov;20(6):747-55. doi: 10.1111/hae.12470. Epub 2014 Jun 3.

ReferenceCitation: Fischer K, Ljung R, Platokouki H, Liesner R, Claeyssens S, Smink E, van den Berg HM. Prospective observational cohort studies for studying rare diseases: the European PedNet Haemophilia Registry. Haemophilia. 2014 Jul;20(4):e280-6. doi: 10.1111/hae.12448. Epub 2014 May 2.

ReferenceCitation: Gouw SC, van der Bom JG, Ljung R, Escuriola C, Cid AR, Claeyssens-Donadel S, van Geet C, Kenet G, Makipernaa A, Molinari AC, Muntean W, Kobelt R, Rivard G, Santagostino E, Thomas A, van den Berg HM; PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med. 2013 Jan 17;368(3):231-9. doi: 10.1056/NEJMoa1208024.

ReferenceCitation: Andersson NG, Auerswald G, Barnes C, Carcao M, Dunn AL, Fijnvandraat K, Hoffmann M, Kavakli K, Kenet G, Kobelt R, Kurnik K, Liesner R, Makipernaa A, Manco-Johnson MJ, Mancuso ME, Molinari AC, Nolan B, Perez Garrido R, Petrini P, Platokouki HE, Shapiro AD, Wu R, Ljung R. Intracranial haemorrhage in children and adolescents with severe haemophilia A or B - the impact of prophylactic treatment. Br J Haematol. 2017 Oct;179(2):298-307. doi: 10.1111/bjh.14844. Epub 2017 Jul 12.

ReferenceCitation: Mancuso ME, Fischer K, Santagostino E, Oldenburg J, Platokouki H, Konigs C, Escuriola-Ettingshausen C, Rivard GE, Cid AR, Carcao M, Ljung R, Petrini P, Altisent C, Kenet G, Liesner R, Kurnik K, Auerswald G, Chambost H, Makipernaa A, Molinari AC, Williams M, van den Berg HM; European Pediatric Network for Haemophilia Management (PedNet) the REMAIN (REal life MAnagement of children with INhibitors) Study Group. Risk Factors for the Progression from Low to High Titres in 260 Children with Severe Haemophilia A and Newly Developed Inhibitors. Thromb Haemost. 2017 Dec;117(12):2274-2282. doi: 10.1160/TH17-01-0059. Epub 2017 Dec 6.

publisher_dissemination: Georg Thieme

ReferenceCitation: Andersson NG, Chalmers EA, Kenet G, Ljung R, Makipernaa A, Chambost H; PedNet Haemophilia Research Foundation. Mode of delivery in hemophilia: vaginal delivery and Cesarean section carry similar risks for intracranial hemorrhages and other major bleeds. Haematologica. 2019 Oct;104(10):2100-2106. doi: 10.3324/haematol.2018.209619. Epub 2019 Feb 21.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: van den Berg HM, Fischer K, Carcao M, Chambost H, Kenet G, Kurnik K, Konigs C, Male C, Santagostino E, Ljung R; PedNet Study Group. Timing of inhibitor development in more than 1000 previously untreated patients with severe hemophilia A. Blood. 2019 Jul 18;134(3):317-320. doi: 10.1182/blood.2019000658. Epub 2019 Jun 11. No abstract available.

ReferenceCitation: Male C, Andersson NG, Rafowicz A, Liesner R, Kurnik K, Fischer K, Platokouki H, Santagostino E, Chambost H, Nolan B, Konigs C, Kenet G, Ljung R, Van den Berg M. Inhibitor incidence in an unselected cohort of previously untreated patients with severe haemophilia B: a PedNet study. Haematologica. 2021 Jan 1;106(1):123-129. doi: 10.3324/haematol.2019.239160.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central
publikationen.ub.uni-frankfurt.de

ReferenceCitation: van den Berg HM, Mancuso ME, Konigs C, D'Oiron R, Platokouki H, Mikkelsen TS, Motwani J, Nolan B, Santagostino E; European Pediatric Network for Haemophilia Management (PedNet). ITI Treatment is not First-Choice Treatment in Children with Hemophilia A and Low-Responding Inhibitors: Evidence from a PedNet Study. Thromb Haemost. 2020 Aug;120(8):1166-1172. doi: 10.1055/s-0040-1713097. Epub 2020 Jun 22.

ReferenceCitation: Andersson NG, Wu R, Carcao M, Claeyssens-Donadel S, Kobelt R, Liesner R, Makipernaa A, Ranta S, Ljung R; ICH study group. Long-term follow-up of neonatal intracranial haemorrhage in children with severe haemophilia. Br J Haematol. 2020 Jul;190(2):e101-e104. doi: 10.1111/bjh.16740. Epub 2020 Jun 9. No abstract available.

ReferenceCitation: Platokouki H, Fischer K, Gouw SC, Rafowicz A, Carcao M, Kenet G, Liesner R, Kurnik K, Rivard GE, van den Berg HM. Vaccinations are not associated with inhibitor development in boys with severe haemophilia A. Haemophilia. 2018 Mar;24(2):283-290. doi: 10.1111/hae.13387. Epub 2017 Dec 15.

ReferenceCitation: Khair K, Ranta S, Thomas A, Lindvall K; PedNet study group. The impact of clinical practice on the outcome of central venous access devices in children with haemophilia. Haemophilia. 2017 Jul;23(4):e276-e281. doi: 10.1111/hae.13241. Epub 2017 May 24.

ReferenceCitation: Hashemi SM, Fischer K, Moons KGM, van den Berg HM; PedNet Study group. Validation of the prediction model for inhibitor development in PUPs with severe haemophilia A. Haemophilia. 2016 Mar;22(2):e116-e118. doi: 10.1111/hae.12895. Epub 2016 Feb 8. No abstract available.

ReferenceCitation: Ranta S, Motwani J, Blatny J, Buhrlen M, Carcao M, Chambost H, Escuriola C, Fischer K, Kartal-Kaess M, de Kovel M, Kenet G, Male C, Nolan B, d'Oiron R, Olivieri M, Zapotocka E, Andersson NG, Konigs C. Dilemmas on emicizumab in children with haemophilia A: A survey of strategies from PedNet centres. Haemophilia. 2023 Sep;29(5):1291-1298. doi: 10.1111/hae.14847. Epub 2023 Aug 30.

repositories_institution: University Library Bern - BORIS - Bern Open Repository and Information System

ReferenceCitation: Labarque V, Mancuso ME, Kartal-Kaess M, Ljung R, Mikkelsen TS, Andersson NG. F8/F9 variants in the population-based PedNet Registry cohort compared with locus-specific genetic databases of the European Association for Haemophilia and Allied Disorders and the Centers for Disease Control and Prevention Hemophilia A or Hemophilia B Mutation Project. Res Pract Thromb Haemost. 2023 Jan 10;7(1):100036. doi: 10.1016/j.rpth.2023.100036. eCollection 2023 Jan.

repository_institution: University of Bern - Bern Open Repository and Information System

repositories:
LIRIAS (KU Leuven)
PubMed Central
boris.unibe.ch

repositories_concat: LIRIAS (KU Leuven);PubMed Central;boris.unibe.ch

ReferenceCitation: Fischer K, Carcao M, Male C, Ranta S, Pergantou H, Kenet G, Kartal-Kaess M, Konigs C, Carvalho M, Alvarez MT, Brakenhoff T, Chambost H, van den Berg HM. Different inhibitor incidence for individual factor VIII concentrates in 1076 previously untreated patients with severe hemophilia A: data from the PedNet cohort. J Thromb Haemost. 2023 Mar;21(3):700-703. doi: 10.1016/j.jtha.2022.11.020. Epub 2022 Dec 22. No abstract available.

ReferenceCitation: Ljung R, de Kovel M, van den Berg HM; PedNet study group. Primary prophylaxis in children with severe haemophilia A and B-Implementation over the last 20 years as illustrated in real-world data in the PedNet cohorts. Haemophilia. 2023 Mar;29(2):498-504. doi: 10.1111/hae.14729. Epub 2022 Dec 26.

ReferenceCitation: Schmidt DE, Michalopoulou A, Fischer K, Motwani J, Andersson NG, Pergantou H, Ranta S; PedNet Study Group. Long-term joint outcomes in adolescents with moderate or severe haemophilia A. Haemophilia. 2022 Nov;28(6):1054-1061. doi: 10.1111/hae.14636. Epub 2022 Aug 4.

ReferenceCitation: Alvarez-Roman MT, Kurnik K; PedNet Study Group. Care for children with haemophilia during COVID-19: Data of the PedNet study group. Haemophilia. 2021 Jul;27(4):e537-e539. doi: 10.1111/hae.14286. Epub 2021 Mar 8. No abstract available.

ReferenceCitation: Minna K, Anne M, Beatrice N, Rainer K, Susanna R. Correction of haemostasis can be reduced to four days for CVAD implantation in severe haemophilia A patients: Data from the PedNet study group. Haemophilia. 2021 May;27(3):392-397. doi: 10.1111/hae.14231. Epub 2021 Mar 21.

ReferenceCitation: Andersson NG, Labarque V, Letelier A, Mancuso ME, Buhrlen M, Fischer K, Kartal-Kaess M, Koskenvuo M, Mikkelsen T, Ljung R; PedNet study group. Novel F8 and F9 gene variants from the PedNet hemophilia registry classified according to ACMG/AMP guidelines. Hum Mutat. 2020 Dec;41(12):2058-2072. doi: 10.1002/humu.24117. Epub 2020 Oct 14.

repositories:
LIRIAS (KU Leuven)
PubMed Central
Pure (Denmark)
boris.unibe.ch

repositories_concat: LIRIAS (KU Leuven);PubMed Central;Pure (Denmark);boris.unibe.ch

ReferenceCitation: Jonker CJ, Oude Rengerink K, Hoes AW, Mol PGM, van den Berg HM. Inhibitor development in previously untreated patients with severe haemophilia: A comparison of included patients and outcomes between a clinical study and a registry-based study. Haemophilia. 2020 Sep;26(5):809-816. doi: 10.1111/hae.14100. Epub 2020 Jul 6.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

location_country:
Finland
Germany
Ireland
Czechia
Canada
France
Portugal
Denmark
Switzerland
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel

location_facility: Van Creveld Kliniek University Medical Center Utrecht

location_facility: Department of Paediatric Haematology/oncology - University Hospital Motol

location_facility: Unidad de Coagulopatias Congenitas Hospital Universitario la Fe

location_facility: Service Hématologique Centre Regional Traitement d'Hemophilie Bicetre

location_facility: The National Hemophilia Center Sheba Medical Center, Tel Hashomer

location_facility: Haemophilia Comprehensive Care Centre, Centre for Thrombosis and Haemostasis Children's University Hospital Brno

location_facility: Institut für Experimentelle Hämatologie und Transfusionsmedizin Universitätsklinikum Bonn

location_facility: Haemophilia-Haemostasis Unit St. Sophia Children's Hospital

location_facility: Dr. v. Haunersches Kinderspital University of Munich

location_facility: A. Bianchi Bonomi Hemophilia and Thrombosis Centre IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Department of Pediatrics, Clinic of Coag. Disorders Karolinska Hospital

location_facility: Centre de traitement des hémophiles Hôpital Universitaire Purpan

location_facility: Medical University of Vienna - Department of Paediatrics

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Unidad de Coagulopatías Hospital Universitario La Paz

location_facility: Birmingham Children's Hospital NHS Trust - Department of Haematology

location_facility: University Hospital Frankfurt & Goethe University - Clinical and Molecular Hemostasis, Department of Pediatrics

location_facility: Division of Hematology/Oncology Hôpital St Justine

location_facility: Dept of Paediatric Haematology Our Lady's Children's Hospital for Sick Children Crumlin

location_facility: Inselspital Bern, University Children's Hospital

location_facility: Centro Hospitalar São João, S. Imuno-hemoterapia

location_facility: Hospital General Unidad de Hemofilia 1 Sur Hospitales Universitarios Virgen del Rocio

location_facility: Children's Hospital Helsinki University Hospital

location_facility: Department of Haematology Royal Hospital for Sick Children

location_facility: Department of Pediatrics Århus Kommunehospital Skejby Sygehus

location_facility: Universitäts-Klinik für Kinder- und Jugendheilkunde

location_facility: Division of Haematology/Oncology Hospital for Sick Children

location_facility: Haemophila Center Great Ormond Street Hospital for Children

location_facility: Service of Pediatric Haematology University Hospital Leuven

location_facility: Service d'Hématologie Pédiatrique Hôpital Universitaire La Timone


title: A Phase Ib, Open-label, Multicenter Study of Oral LXH254-centric Combinations in Adult Patients With Advanced or Metastatic KRAS or BRAF Mutant Non-Small Cell Lung Cancer or NRAS Mutant Melanoma

summary: To characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.

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

location_facility: Sarah Cannon Research Institute Tennessee Oncology


title: Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

summary: The objectives of this study are twofold •To evaluate the safety and efficacy of 0.1% AGN-195263 administered twice daily compared to its vehicle in patients with evaporative dry eye (EDE) •To evaluate the systemic pharmacokinetics of 0.1% AGN-195263 administered twice daily in patients with EDE

lead_sponsor: Allergan

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
United States
Spain
Turkey
Taiwan
Czechia
Philippines
France

location_facility: CHU de Bordeaux, Service d'Ophtalmologie

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

location_facility: Gutenberg University Medical School, Dept of Ophthalmology

location_facility: Specjalistyczna Praktyka Lekarska prof. Edward Wylegala

location_facility: Dept. of Ophthalmology Semmelweis University

location_facility: University Hospital of Cologne, Dept of Ophthalmology

location_facility: University of Valladolid, Facultad Medicina

location_facility: Institto de Microcirugia Ocular C/Josep Maria Llado

location_facility: CHU Hopital Morvan (Bat 4) Service Daviel Ophtalmologie

location_facility: Rapallo Hospital, Opthalmology Department

location_facility: University of Debrecen, Dept of Opthalmology, (DE OEC Szemklinika)

location_facility: Clinico de Barcelona Casa de la Maternidad

location_facility: Uniwersyteck Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: University of Szeged Szent-Györgyi Albert Clinical Center, Faculty of Medicine, Dept of Ophthalmology

location_facility: Ospedale San Giuseppe, Universita di Milano

location_facility: University of Pisa, Neurosciences - Section of Ophthalmology

location_facility: Ludwig-Maximilians-University, Dept of Ophthalmology

location_facility: Newcastle University School of Medicine, Dept of Ophthamology


lead_sponsor: GlaxoSmithKline

summary: This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior treatment with at least one line of endocrine therapy. The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK525762 that may be combined safely with fulvestrant. Phase I will follow a modified toxicity probability interval (mTPI) design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded to collect additional safety data. This will be followed by a double-blind, randomized controlled Phase II, to identify the clinical activity of the two study treatments when given in combination. The composition of Phase II will be selected at the end of Phase I.

title: A Phase I/II Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK525762 in Combination With Fulvestrant in Subjects With Hormone Receptor-positive/HER2-negative (HR+/HER2-) Advanced or Metastatic Breast Cancer

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

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


lead_sponsor: Baxalta now part of Shire

summary:
Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study.

The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia.

All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so.

Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: Toronto General Hospital, University Health Network

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Instituto de Neurologia de Curitiba - Hospital Ecoville

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Fondazione Istituto Neurologico Casimiro Mondino

location_facility: Azienda Ospedaliero Universitaria Pisana

title: Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Germany
Italy
Poland
Colombia
Slovakia
United Kingdom
Argentina
Denmark
Brazil
Mexico
United States
Spain
Greece
Turkey
Czechia
Canada
Serbia
France