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AURORA: A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NCT03028740)

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.
  • Drug: Cenicriviroc
    1 tablet QD
    • CVC
  • Drug: Placebo
    1 tablet QD
    Ages eligible for Study
    18 Years to 75 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • 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.
    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
    • 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
    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.

    338 locations

    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Start:
    19 April, 2017
    Updated:
    29 November, 2017
    Participants:
    2000
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