Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
- Conditions
- Nonalcoholic SteatohepatitisNon-alcoholic Fatty Liver DiseaseLiver Cirrhosis
- Interventions
- Registration Number
- NCT03059446
- Lead Sponsor
- Tobira Therapeutics, Inc.
- Brief 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 \[NCT03028740\].
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 167
- Successful completion of both Treatment Period 1 and Treatment Period 2, of the CENTAUR Study (652-2-203), including a Year 2 liver biopsy.
- 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).
- Prior or planned liver transplantation
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cenicriviroc (CVC) 150 mg Cenicriviroc Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (AE) Day 1 until the study was terminated (up to approximately 4 years) An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Universitaetsklinikum Heidelberg - Innere Medizin IV
🇩🇪Heidelberg, Germany
Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
🇩🇪Koeln, Germany
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
🇮🇹Milano, Italy
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
Antwerp University Hospital (UZA)
🇧🇪Edegem, Belgium
Delta Research Partners, Llc
🇺🇸Bastrop, Louisiana, United States
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Tandem Clinical Research LLC
🇺🇸Marrero, Louisiana, United States
Digestive Health Specialists
🇺🇸Tupelo, Mississippi, United States
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Uniklinik RWTH Aachen
🇩🇪Aachen, Germany
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Mayo Clinic Hospital
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Duke University Medical Center (DUMC)
🇺🇸Durham, North Carolina, United States
The University of Texas - Health Science Center & Medical School at Houston
🇺🇸Houston, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Franco Felizarta, MDv
🇺🇸Bakersfield, California, United States
Kansas Medical Clinic PA
🇺🇸Topeka, Kansas, United States
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
University of California, San Diego (UCSD) - Medical Center
🇺🇸San Diego, California, United States
University of California, San Diego (UCSD)
🇺🇸La Jolla, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
🇺🇸Tampa, Florida, United States
Upland Clinical Research
🇺🇸Upland, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Minnesota Gastroenterology, P.A.
🇺🇸Saint Paul, Minnesota, United States
University of Buffalo - Erie County Medical Center
🇺🇸Buffalo, New York, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
ClinSearch LLC
🇺🇸Chattanooga, Tennessee, United States
Digestive Health Research
🇺🇸Lebanon, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Hopital Saint Antoine
🇫🇷Paris, France
The Texas Liver Institute
🇺🇸San Antonio, Texas, 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
Purpan CHU Toulouse
🇫🇷Toulouse, cedex 9, France
Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
🇩🇪Hamburg, Germany
Prince of Wales Hospital
🇭🇰Shatin, Hong Kong
Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
AOU Policlinico Paolo Giaccone di Palermo
🇮🇹Palermo, Italy
University Hospital Giessen and Marburg GmbH
🇩🇪Marburg, Germany
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
ID Clinic
🇵🇱Myslowice, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
🇵🇱Wroclaw, Poland
Charite - University Hospital Berlin - Campus Virchow - Hospital
🇩🇪Berlin, Germany
Digestive Health Specialists of the Southeast - Dothan
🇺🇸Dothan, Alabama, United States
Consultants for Clinical Research - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Wake Research Associates, LLC - Raleigh
🇺🇸Raleigh, North Carolina, United States
Eugastro GmbH
🇩🇪Leipzig, Germany
Advanced Medical Research
🇺🇸Port Orange, Florida, United States
Island View Gastroenterology Associates
🇺🇸Ventura, California, United States
University of Miami - Schiff Center for Liver Diseases
🇺🇸Miami, Florida, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Mercy Medical Center - Baltimore, Maryland
🇺🇸Baltimore, Maryland, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Virginia Commonwealth University Medical College of Virginia
🇺🇸Richmond, Virginia, United States
CHU Angers
🇫🇷Angers Cedex 09, France
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
UCL Saint Luc Bruxelles
🇧🇪Brussel, Belgium
University Hospital Erasmus (Brussels)
🇧🇪Bruxelles, Belgium