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

• Status: Terminated
• Trial end date: 2021-03-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tobira Therapeutics, Inc.
• Treatments: Cenicriviroc; TAK-652

Criteria

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).