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

• Status: Terminated
• Trial end date: 2021-01-05
• Target enrollment: 0
• Participant gender: All

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].

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tobira Therapeutics, Inc.
• Treatments: Cenicriviroc

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.