SHS_610057 KOWK CALL 17055

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

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

Inclusion Criteria:

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


Exclusion Criteria:

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

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

History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma

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
Phase III
NCT03028740
All Other
Hepatic
Kris Kowdley, M.D.
Allergan
Adel Islam
  • Swedish Medical Center