AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH
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The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.
Condition or disease
Drug: CenicrivirocDrug: Placebo
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. Subjects from Part 1 will continue into Part 2 and additional subjects 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.
Superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy [ Time Frame: Measurements at Baseline and 12 months ]
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis
Superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ]
Secondary Outcome Measures :
Effect of CVC compared to placebo on liver histology at Month 60 relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage AND no worsening of steatohepatitis [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ]
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female subjects 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
Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides
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 mU/mL at Screening.
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
AST > 200 IU/L in males and females at Screening
ALT > 250 IU/L in males and > 200 IU/L in females at Screening
HbA1c > 10% at Screening
Serum albumin < 3.5 g/dL
Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
Platelet count < 100,000/mm3
Total bilirubin > 1.5 mg/dL
International normalized ratio (INR) > 1.3
Model of end stage liver disease (MELD) score > 12
Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
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
Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, or a thiazolidinedione (TZD) for less than 6 months of stable therapy prior to the Screening liver biopsy