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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
167

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tobira Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Liver Cirrhosis

Clinical Trials on Cenicriviroc

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings