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

Stopped early · Phase 2

Conditions studied: Nonalcoholic Steatohepatitis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease

In brief

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 \[NCT03028740\].

Key facts

Study ID

NCT03059446

Run by

Tobira Therapeutics, Inc.

People needed

167

Starts

2017-02-14

Expected to finish

2021-01-05

Last updated by the study team

2022-02-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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
• University of Miami - Schiff Center for Liver Diseases — Miami, Florida, United States
• Advanced Medical Research — Port Orange, Florida, United States
• Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• Kansas Medical Clinic PA — Topeka, Kansas, United States
• Delta Research Partners, Llc — Bastrop, Louisiana, United States
• Tandem Clinical Research LLC — Marrero, Louisiana, United States
• Tulane University Medical Center — New Orleans, Louisiana, United States
• Mercy Medical Center - Baltimore, Maryland — Baltimore, Maryland, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Minnesota Gastroenterology, P.A. — Saint Paul, Minnesota, United States
• Digestive Health Specialists — Tupelo, Mississippi, United States
• Digestive Health Specialists of the Southeast - Dothan — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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