Last updated on April 2019

AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nonalcoholic Steatohepatitis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Male and female subjects aged between 18-75 years
  2. Ability to understand and sign a written informed consent form (ICF)
  3. Histological evidence of NASH based on central reading of the Screening biopsy
  4. Histological evidence of Stage 2 to 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides
  5. 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:

  1. Inability to undergo a liver biopsy
  2. Hepatitis B surface antigen (HBsAg) positive
  3. Hepatitis C antibody (HCVAb) positive
  4. Human immunodeficiency virus (HIV)-1 or HIV-2 infection
  5. Prior or planned liver transplantation
  6. Other known causes of chronic liver disease
  7. History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
  8. Alcohol consumption greater than 21 units/week for males or 14 units/week for females
  9. AST > 200 IU/L in males and females at Screening
  10. ALT > 250 IU/L in males and > 200 IU/L in females at Screening
  11. HbA1c > 10% at Screening
  12. Serum albumin < 3.5 g/dL
  13. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
  14. Platelet count < 100,000/mm3
  15. Total bilirubin > 1.5 mg/dL
  16. International normalized ratio (INR) > 1.3
  17. Model of end stage liver disease (MELD) score > 12
  18. Weight reduction through bariatric surgery in the past 5 years or planned during the conduct of the study (including gastric banding)
  19. History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
  20. Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
  21. Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
  22. Females who are pregnant or breastfeeding
  23. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents
  24. 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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