Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects with Liver Fibrosis - CENTAUR

Tobira Therapeutics, Inc.0 个研究点目标入组 252 人开始时间: 2014年11月4日最近更新: 2017年10月2日

适应症

试验速览

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•--Histological evidence of NASH, based on Screening biopsy, with a NAS of ? 4 with at least 1 in each component of NAS
•--Histological evidence of liver fibrosis defined as NASH CRN System Stage 1 to 3, inclusive, based on Screening biopsy
•--Meeting any of the 3 following major criteria (a, b, c):
•a. Documented evidence of type 2 diabetes mellitus (T2DM)
•b. High BMI (> 25 kg/m2) with at least 1 of the following criteria of the metabolic syndrome, as defined by the NCEP:
•i. Central obesity: waist circumference ? 102 cm or 40 inches (male), ? 88 cm or 35 inches (female)
•ii. Dyslipidemia: TG ? 1.7 mmol/L (150 mg/dL)
•iii. Dyslipidemia: HDL-cholesterol < 40 mg/dL (male), < 50 mg/dL (female)
•iv. Blood pressure ? 130/85 mmHg (or treated for hypertension)
•v. Fasting plasma glucose ? 6.1 mmol/L (110 mg/dL)
•c. Bridging fibrosis (NASH CRN Stage 3) and/or definite NASH (NAS ? 5)
•--Agree to have one liver biopsy at Screening, one at Year 1, and one at the end
•of study treatment (Year 2)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 226
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 26

•--Hepatitis B surface antigen (HBsAg) positive
•--Hepatitis C antibody (HCVAb) positive with the following 2 exceptions:
•a. Subjects previously treated for viral hepatitis C with at least a 1-year period since documented sustained virologic response at Week 12 (post-treatment) may be eligible if all other eligibility criteria are met
•b. Subjects with presence of hepatitis C antibody but negative hepatitis C virus RNA without treatment (i.e., spontaneous clearance) may be eligible if all other eligibility criteria are met
•--Prior or planned liver transplantation
•--Other known causes of chronic liver disease, including alcoholic liver disease
•--History 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 (one unit of alcohol is ½ pint of beer [285 mL], 1 glass of spirits
•[25 mL] or 1 glass of wine [125 mL])
•-HIV-1 and HIV-2 infection due to CVC's anti-HIV activity

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