A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects With Advanced Liver Disease

Janssen-Cilag International NV0 个研究点目标入组 110 人开始时间: 2014年10月16日最近更新: 2016年6月13日

试验速览

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•- Participant must have chronic Hepatitis C virus (HCV) genotype 1b infection confirmed at Screening
•- Participant must have HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL) at Screening - Participant must have documented advanced fibrosis or compensated liver cirrhosis at Screening (METAVIR F3 or F4)
•- Participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [CT] scan or magnetic resonance imaging [MRI]) within 6 months prior to the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma
•- Participant must have a body mass index (BMI) greater than or equal to (>=) 18 Kilogram per meter^2 (kg/m^2)
•- Participant must be treatment naive (that is, have not received prior treatment for HCV with any approved or investigational drug)
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•- Participant has co-infection with HCV of a genotype other than genotype 1b
•- Participant has the presence of genetic variants coding for the NS5A-Y93H and/or L31M/V amino acid substitutions at Screening
•- Participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy)
•- Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson’s disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
•- Participant has any other uncontrolled clinically significant disease or clinically significant findings during Screening that in the opinion of the investigator could compromise the Participants' safety or could interfere with the Participant participating in and completing the study
•- Participant has co-infection with human immunodeficiency virus (HIV) type 1 or 2 (positive HIV-1 or HIV-2 antibody test at Screening)
•- Participant has received a solid organ transplant

发起方