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

Trial ID or NCT#

NCT03028740

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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).
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Investigator(s)

Paul Kwo
Paul Kwo
Hepatologist, Transplant hepatologist, Gastroenterologist
Professor of Medicine (Gastroenterology and Hepatology)

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Contact

Swati Toppo
650.497.4151

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View on ClinicalTrials.gov