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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.

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].

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Liver Cirrhosis Non-alcoholic Fatty Liver Disease Drug: Cenicriviroc Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : November 27, 2029
Estimated Study Completion Date : July 1, 2030


Arm Intervention/treatment
Experimental: Cenicriviroc
Cenicriviroc (CVC) 150 mg tablet once daily in the morning with food until CVC is commercially available or the study is terminated.
Drug: Cenicriviroc
Cenicriviroc 150 mg tablet once daily in the morning with food.
Other Name: CVC




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059446


Locations
Show Show 83 study locations
Sponsors and Collaborators
Tobira Therapeutics, Inc.
Investigators
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Study Director: Eduardo B Martins Allergan
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Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03059446    
Other Study ID Numbers: 3152-201-002
2016-004754-15 ( EudraCT Number )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
TAK-652
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents