Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis

January 4, 2022 updated by: Tobira Therapeutics, Inc.

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

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].

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital and Women's Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Central Adelaide Local Health Network Inc - Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
  • Belgium
      • Brussel, Belgium, 1200
        • UCL Saint Luc Bruxelles
      • Bruxelles, Belgium, 1070
        • University Hospital Erasmus (Brussels)
      • Edegem, Belgium, 2650
        • Antwerp University Hospital (UZA)
  • France
      • Angers Cedex 09, France, 49933
        • CHU Angers
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Toulouse, cedex 9, France, 31059
        • Purpan CHU Toulouse
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH Aachen
      • Berlin, Germany, 13353
        • Charite - University Hospital Berlin - Campus Virchow - Hospital
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf - I. Medizinische Klinik und Poliklinik
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg - Innere Medizin IV
      • Koeln, Germany, 50937
        • Uniklinik Koeln, Poliklinik fuer Endokrinologie, Diabetologie und Praeventivmedizin (ZEDP)
      • Leipzig, Germany, 4103
        • Eugastro GmbH
      • Marburg, Germany, 35043
        • University Hospital Giessen and Marburg GmbH
  • Hong Kong
      • Shatin, Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S. Orsola-Malpighi
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
      • Palermo, Italy, 90127
        • AOU Policlinico Paolo Giaccone di Palermo
  • Poland
      • Myslowice, Poland, 41-400
        • ID Clinic
      • Wroclaw, Poland, 50-349
        • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
  • Puerto Rico
      • San Juan, Puerto Rico, 927
        • Fundacion de Investigacion de Diego
  • Spain
      • Barcelona, Spain, 8022
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 8026
        • Hospital de la Santa Creu i Sant Pau Barcelona
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham NHS Treatment Centre
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast - Dothan
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
      • Tucson, Arizona, United States, 85712
        • Adobe Clinical Research, LLC
    • California
      • Bakersfield, California, United States, 93301
        • Franco Felizarta, MDv
      • La Jolla, California, United States, 92037
        • University of California, San Diego (UCSD)
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
      • San Diego, California, United States, 92093
        • University of California, San Diego (UCSD) - Medical Center
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
      • Upland, California, United States, 91786
        • Upland Clinical Research
      • Ventura, California, United States, 93003
        • Island View Gastroenterology Associates
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami - Schiff Center for Liver Diseases
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research
      • Tampa, Florida, United States, 33606
        • Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Kansas Medical Clinic PA
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Delta Research Partners, LLC
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research LLC
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School of Medicine
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center - Baltimore, Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Minnesota Gastroenterology, P.A.
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Digestive Health Specialists
    • New York
      • Buffalo, New York, United States, 14215
        • University of Buffalo - Erie County Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center (DUMC)
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC - Raleigh
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Consultants for Clinical Research - Cincinnati
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch LLC
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Lebanon, Tennessee, United States, 37090
        • Digestive Health Research
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas - Health Science Center & Medical School at Houston
      • San Antonio, Texas, United States, 78215
        • The Texas Liver Institute
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Virginia Commonwealth University Medical College of Virginia
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Cenicriviroc
Cenicriviroc immediate release tablets
Other Names:
  • CVC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (AE)
Time Frame: 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.
Day 1 until the study was terminated (up to approximately 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tobira Therapeutics, Inc.

Investigators

  • Study Director: Eduardo B Martins, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2017

Primary Completion (Actual)

January 5, 2021

Study Completion (Actual)

January 5, 2021

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

February 2, 2022

Last Update Submitted That Met QC Criteria

January 4, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3152-201-002
  • 2016-004754-15 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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