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Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis | Clinical Trials | Clareo Health

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Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis

CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis

NCT02217475•Tobira Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult participants aged between 18-75
•Histological evidence of NASH, based on biopsy, with a Nonalcoholic fatty liver disease Activity Score (NAS) of \>= 4 with at least 1 in each component of NAS
•Histological evidence of liver fibrosis defined as NASH Clinical Research Network (CRN) System Stage 1 to 3
•Meeting any of the 3 major criteria (a, b, c):
•1. Documented evidence of type 2 diabetes mellitus
•2. High body mass index (\> 25 kg/m\^2) with at least one of the following criteria of metabolic syndrome, as defined by the National Cholesterol Education Program:
•* Central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 35 inches (female)
•* Dyslipidemia: Triglycerides ≥ 1.7 mmol/L (150 mg/dL)
•* Dyslipidemia: High-density lipoprotein (HDL)-cholesterol \< 40 mg/dL (male), \< 50 mg/dL (female)
•* Blood pressure ≥ 130/85 mmHg (or currently being treated for hypertension)
+12 more criteria

Exclusion Criteria

•Hepatitis B surface Antigen (HBsAg) positive
•Hepatitis C antibody (HCVAb) positive with the following 2 exceptions:

Locations (91)

Dothan, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Rialto, California, United States

San Diego, California, United States

San Francisco, California, United States

Littleton, Colorado, United States

Miami, Florida, United States

Tampa, Florida, United States

Key Dates

Start Date

September 18, 2014

Primary Completion Date

June 30, 2016

Completion Date

June 22, 2017

Last Updated

May 10, 2019

Enrollment

289

ACTUAL participants

Conditions

Nonalcoholic Steatohepatitis

Interventions

Cenicriviroc

DRUG

Placebo

DRUG

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

NCT02815891

Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis

View study

RECRUITINGNA

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

NCT03587831

NASH - Nonalcoholic Steatohepatitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis

Inclusion Criteria

Exclusion Criteria

A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects

Hepatic Energy Fluxes in NASH and NAS Patients

Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis

LITMUS Imaging Study