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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis

In brief

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.

Key facts

Study ID

NCT03028740

Run by

Tobira Therapeutics, Inc.

People needed

1778

Starts

2017-04-05

Expected to finish

2021-03-09

Last updated by the study team

2022-03-10

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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
• Hemoglobin A1c (HbA1c) >10% at Screening
• Serum albumin <3.5 gram (g)/deciliter (dL) at Screening
• Estimated glomerular filtration rate (eGFR) < 50 mL/minute (min)/1.73 meter (m)\^2 according to the Modification of Diet in Renal Disease (MDRD) equation
• Platelet count <100,000/millimeter (mm)\^3
• Total bilirubin >1.5 milligram (mg)/dL
• International normalized ratio (INR) >1.3
• Model of end stage liver disease (MELD) score >12
• Weight reduction, defined as ≥7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (including gastric banding and sleeve surgery)
• History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
• Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
• Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
• Females who are pregnant or breastfeeding
• Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (eg, interleukins, interferons, cyclosporine, tacrolimus) except for vaccines or short-term corticosteroids
• Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or sodium-glucose cotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Participants on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, participants need to be on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).

Where it is running

• 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
• Hope Clinical Research — Canoga Park, California, United States
• GW Research — Chula Vista, California, United States
• eStudySite — Chula Vista, California, United States
• Southern California Research Center — Coronado, California, United States
• Citrus Valley Gastroenterology — Covina, California, United States
• TriWest Research Associates — El Cajon, California, United States
• University of San Francisco, Fresno Medical Education Program — Fresno, California, United States
• Fresno Clinical Research Center (FCRC) — Fresno, California, United States
• National Research Institute — Huntington Park, California, United States
• University of California San Diego — La Jolla, California, United States
• eStudySite — La Mesa, California, United States
• Om Research — Lancaster, California, United States
• Southern California Kaiser Permanente, Los Angeles Medical Center — Los Angeles, California, United States
• GastroIntestinal Biosciences — Los Angeles, California, United States
• Global Research Institute — Los Angeles, California, United States
• Summit Internal Medicine — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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