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:

   - 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

   - Subjects included in Part1 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. Subjects 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 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 at Screening

   - 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, 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 SGLT1 inhibitor, or
   a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver
   biopsy. Subjects 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, subjects need to be on stable therapy for at least 6 months prior to the day
   historical liver biopsy was performed).

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