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

Tobira Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Liver Cirrhosis

Non-alcoholic Fatty Liver Disease

Nonalcoholic Steatohepatitis

Treatments

Drug: Cenicriviroc

Study type

Interventional

Funder types

Industry

Identifiers

NCT03059446

2016-004754-15 (EudraCT Number)

3152-201-002

Details and patient eligibility

About

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].

Enrollment

167 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.