Study Stopped
This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.
Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
2 other identifiers
interventional
167
11 countries
71
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 \[NCT03028740\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2017
Typical duration for phase_2
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2017
CompletedStudy Start
First participant enrolled
February 14, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2021
CompletedResults Posted
Study results publicly available
February 2, 2022
CompletedFebruary 2, 2022
September 1, 2021
3.9 years
February 3, 2017
January 4, 2022
January 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (AE)
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.
Day 1 until the study was terminated (up to approximately 4 years)
Study Arms (1)
Cenicriviroc (CVC) 150 mg
EXPERIMENTALCenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (71)
Digestive Health Specialists of the Southeast - Dothan
Dothan, Alabama, 36305, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Adobe Clinical Research, LLC
Tucson, Arizona, 85712, United States
Franco Felizarta, MDv
Bakersfield, California, 93301, United States
University of California, San Diego (UCSD)
La Jolla, California, 92037, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
University of California, San Diego (UCSD) - Medical Center
San Diego, California, 92093, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Upland Clinical Research
Upland, California, 91786, United States
Island View Gastroenterology Associates
Ventura, California, 93003, United States
University of Miami - Schiff Center for Liver Diseases
Miami, Florida, 33136, United States
Advanced Medical Research
Port Orange, Florida, 32127, United States
Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
Tampa, Florida, 33606, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, 52242, United States
Kansas Medical Clinic PA
Topeka, Kansas, 66606, United States
Delta Research Partners, Llc
Bastrop, Louisiana, 71220, United States
Tandem Clinical Research LLC
Marrero, Louisiana, 70072, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland, 21202, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, 55114, United States
Digestive Health Specialists
Tupelo, Mississippi, 38801, United States
University of Buffalo - Erie County Medical Center
Buffalo, New York, 14215, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710, United States
Wake Research Associates, LLC - Raleigh
Raleigh, North Carolina, 27612, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research - Cincinnati
Cincinnati, Ohio, 45249, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
ClinSearch LLC
Chattanooga, Tennessee, 37421, United States
Gastro One
Germantown, Tennessee, 38138, United States
Digestive Health Research
Lebanon, Tennessee, 37090, United States
The University of Texas - Health Science Center & Medical School at Houston
Houston, Texas, 77030, United States
The Texas Liver Institute
San Antonio, Texas, 78215, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Virginia Commonwealth University Medical College of Virginia
Richmond, Virginia, 23249, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Royal Brisbane Hospital and Women's Hospital
Herston, Queensland, 4029, Australia
Central Adelaide Local Health Network Inc - Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
University Hospital Erasmus (Brussels)
Brussels, 1070, Belgium
UCL Saint Luc Bruxelles
Brussels, 1200, Belgium
Antwerp University Hospital (UZA)
Edegem, 2650, Belgium
CHU Angers
Angers, 49933, France
Hopital Saint Antoine
Paris, 75012, France
Purpan CHU Toulouse
Toulouse, 31059, France
Uniklinik RWTH Aachen
Aachen, 52074, Germany
Charite - University Hospital Berlin - Campus Virchow - Hospital
Berlin, 13353, Germany
Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
Cologne, 50937, Germany
Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
Hamburg, 20246, Germany
Universitaetsklinikum Heidelberg - Innere Medizin IV
Heidelberg, 69120, Germany
Eugastro GmbH
Leipzig, 4103, Germany
University Hospital Giessen and Marburg GmbH
Marburg, 35043, Germany
Prince of Wales Hospital
Shatin, Hong Kong, Hong Kong
Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122, Italy
AOU Policlinico Paolo Giaccone di Palermo
Palermo, 90127, Italy
ID Clinic
Mysłowice, 41-400, Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw, 50-349, Poland
Fundacion de Investigacion de Diego
San Juan, 927, Puerto Rico
Hospital Universitario Vall d'Hebron
Barcelona, 8022, Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, 8026, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Nottingham NHS Treatment Centre
Nottingham, NG7 2UH, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Eduardo B Martins
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2017
First Posted
February 23, 2017
Study Start
February 14, 2017
Primary Completion
January 5, 2021
Study Completion
January 5, 2021
Last Updated
February 2, 2022
Results First Posted
February 2, 2022
Record last verified: 2021-09