Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
NCT ID: NCT03059446
Last Updated: 2022-02-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
167 participants
INTERVENTIONAL
2017-02-14
2021-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cenicriviroc (CVC) 150 mg
Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
Cenicriviroc
Cenicriviroc immediate release tablets
Interventions
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Cenicriviroc
Cenicriviroc immediate release tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of:
* Histopathological progression to cirrhosis
* Model for end-stage liver disease (MELD) score ≥ 15
* Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic)
* Hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture).
Exclusion Criteria
* Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's disease, hemochromatosis, or iron overload, or Alpha-1 antitrypsin (A1AT) deficiency.
18 Years
75 Years
ALL
No
Sponsors
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Tobira Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eduardo B Martins
Role: STUDY_DIRECTOR
Allergan
Locations
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Digestive Health Specialists of the Southeast - Dothan
Dothan, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Franco Felizarta, MDv
Bakersfield, California, United States
University of California, San Diego (UCSD)
La Jolla, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
University of California, San Diego (UCSD) - Medical Center
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
Upland Clinical Research
Upland, California, United States
Island View Gastroenterology Associates
Ventura, California, United States
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, United States
Advanced Medical Research
Port Orange, Florida, United States
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Kansas Medical Clinic PA
Topeka, Kansas, United States
Delta Research Partners, Llc
Bastrop, Louisiana, United States
Tandem Clinical Research LLC
Marrero, Louisiana, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, United States
Digestive Health Specialists
Tupelo, Mississippi, United States
University of Buffalo - Erie County Medical Center
Buffalo, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, United States
Wake Research Associates, LLC - Raleigh
Raleigh, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Consultants for Clinical Research - Cincinnati
Cincinnati, Ohio, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
ClinSearch LLC
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Digestive Health Research
Lebanon, Tennessee, United States
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas, United States
The Texas Liver Institute
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Royal Brisbane Hospital and Women's Hospital
Herston, Queensland, Australia
Central Adelaide Local Health Network Inc - Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
University Hospital Erasmus (Brussels)
Brussels, , Belgium
UCL Saint Luc Bruxelles
Brussels, , Belgium
Antwerp University Hospital (UZA)
Edegem, , Belgium
CHU Angers
Angers, , France
Hopital Saint Antoine
Paris, , France
Purpan CHU Toulouse
Toulouse, , France
Uniklinik RWTH Aachen
Aachen, , Germany
Charite - University Hospital Berlin - Campus Virchow - Hospital
Berlin, , Germany
Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
Cologne, , Germany
Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
Hamburg, , Germany
Universitaetsklinikum Heidelberg - Innere Medizin IV
Heidelberg, , Germany
Eugastro GmbH
Leipzig, , Germany
University Hospital Giessen and Marburg GmbH
Marburg, , Germany
Prince of Wales Hospital
Shatin, , Hong Kong
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
Milan, , Italy
AOU Policlinico Paolo Giaccone di Palermo
Palermo, , Italy
ID Clinic
Mysłowice, , Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw, , Poland
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Nottingham NHS Treatment Centre
Nottingham, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004754-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3152-201-002
Identifier Type: -
Identifier Source: org_study_id
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