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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03059446
Recruitment Status : Enrolling by invitation
First Posted : February 23, 2017
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Tobira Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date September 3, 2020
Actual Study Start Date  ICMJE February 14, 2017
Estimated Primary Completion Date November 27, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
Number of Participants with Treatment-emergent Adverse Events (AE) [ Time Frame: Day 1 until the drug is commercially available or the study is terminated (Approximately 2 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 this treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Participants With Nonalcoholic Steatohepatitis
Official Title  ICMJE Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Nonalcoholic Steatohepatitis
  • Liver Cirrhosis
  • Non-alcoholic Fatty Liver Disease
Intervention  ICMJE Drug: Cenicriviroc
Cenicriviroc 150 mg tablet once daily in the morning with food.
Other Name: CVC
Study Arms  ICMJE Experimental: Cenicriviroc
Cenicriviroc (CVC) 150 mg tablet once daily in the morning with food until CVC is commercially available or the study is terminated.
Intervention: Drug: Cenicriviroc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)
560
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2017)
200
Estimated Study Completion Date  ICMJE July 1, 2030
Estimated Primary Completion Date November 27, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 cirrhoses
  • 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 encephalophathy (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-antitrypsis (A1AT) deficiency.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   France,   Germany,   Hong Kong,   Israel,   Italy,   New Zealand,   Poland,   Puerto Rico,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03059446
Other Study ID Numbers  ICMJE 3152-201-002
2016-004754-15 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tobira Therapeutics, Inc.
Study Sponsor  ICMJE Tobira Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eduardo B Martins Allergan
PRS Account Tobira Therapeutics, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP