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AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)

AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis

NCT03028740•Tobira Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.

Detailed Description

The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network \[NASH CRN\]) and no worsening of steatohepatitis at Month 12. Participants from Part 1 will continue into Part 2 and additional participants will be newly randomized in Part 2 to determine long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female participants aged between 18-75 years
•Ability to understand and sign a written informed consent form (ICF)
•Histological evidence of NASH based on central reading of the Screening biopsy
•Participants included in Part 1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides. Participants newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period biopsy slides. Historical biopsy can be used, provided the criteria listed on Item 3a above are fulfilled.
•Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥12 months and serum follicle-stimulating hormone (FSH) ≥30 milliunits (mU)/milliliter (mL) at Screening.

Exclusion Criteria

•Inability to undergo a liver biopsy
•Hepatitis B surface antigen (HBsAg) positive
•Hepatitis C antibody (HCVAb) positive
•Human immunodeficiency virus (HIV)-1 or HIV-2 infection
•Prior or planned liver transplantation
•Other known causes of chronic liver disease
•History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
•Alcohol consumption greater than 21 units/week for males or 14 units/week for females
•Aspartate transaminase (AST) \>200 International units (IU)/liter (L) in males and females at Screening
•Alanine transaminase (ALT) \>250 IU/L in males and \>200 IU/L in females at Screening
+14 more criteria

Locations (346)

Summit Internal Medicine

Birmingham, Alabama, United States

Cullman Clinical Trials

Cullman, Alabama, United States

Digestive Health Specialists of the Southeast

Dothan, Alabama, United States

Objective GI D/B/A North Alabama GI Research Center

Madison, Alabama, United States

The Institute for Liver Health

Chandler, Arizona, United States

Adobe Gastroenterology Research, LLC

Tucson, Arizona, United States

Del Sol Research Management, LLC

Tucson, Arizona, United States

Del Sol Research Management LLC

Tucson, Arizona, United States

Arkansas Diagnostic Center

Little Rock, Arkansas, United States

Franco Felizarta MD

Bakersfield, California, United States

Key Dates

Start Date

April 5, 2017

Primary Completion Date

January 12, 2021

Completion Date

March 9, 2021

Last Updated

March 10, 2022

Enrollment

1,778

ACTUAL participants

Conditions

Nonalcoholic Steatohepatitis

Interventions

Placebo

DRUG

Cenicriviroc

DRUG

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NCT02815891

Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis

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RECRUITINGNA

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic 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: March 10, 2022Data 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.

View ClinicalTrials.gov Terms and Conditions

AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)

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

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