Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Tobira Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Cenicriviroc
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Angela Fuller
650-721-4288
Recruiting