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

Phase 2

Terminated

• Conditions: Nonalcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
• Interventions: Drug: Cenicriviroc

• Registration Number: NCT03059446
• Lead Sponsor: 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 \[NCT03028740\].

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-03
• Study Start: 2017-02-14
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Primary Completion: 2021-01-05
• Study Completion: 2021-01-05
• Status Verified: 2021-09
• Results First Submitted: 2022-01-04
• Results First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Results First Posted: 2022-02-02
• Last Update Posted: 2022-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cenicriviroc (CVC) 150 mg	Cenicriviroc	Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (AE)	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.

Trial Locations

Locations (71)

Digestive Health Specialists of the Southeast - Dothan; 🇺🇸 Dothan, Alabama, United States

Mayo Clinic Hospital; 🇺🇸 Phoenix, Arizona, United States

Adobe Clinical Research, LLC; 🇺🇸 Tucson, Arizona, United States

Franco Felizarta, MDv; 🇺🇸 Bakersfield, California, United States

University of California, San Diego (UCSD); 🇺🇸 La Jolla, California, United States

Inland Empire Liver Foundation; 🇺🇸 Rialto, California, United States

University of California, San Diego (UCSD) - Medical Center; 🇺🇸 San Diego, California, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States

Upland Clinical Research; 🇺🇸 Upland, California, United States

Island View Gastroenterology Associates; 🇺🇸 Ventura, California, United States

Scroll for more (61 remaining)