A Study of TMC435 plus Pegylated Interferon alfa-2a and Ribavirin in Participants with Chronic HCV Infectio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

-treatment-naïve (previously untreated) with confirmed chronic Hepatitis C Virus (HCV) infection
- liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening
-liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis without or with few septa)
- genotype 1 HCV infection (confirmed at screening)
- Before screening, a woman must be either not of childbearing potential: postmenopausal (> 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy OR of childbearing potential and practicing two different highly effective methods of birth control (including at least one barrier method) consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies: e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence (when this is in line with the preferred and usual lifestyle of the participant) Note: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin 2 highly effective methods of birth control, as described above
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use two different highly effective methods of birth control (including at least one barrier method). A man who is sexually active with a woman of childbearing potential and has had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. All men must also not donate sperm during the study and for 6 months (or longer if dictated by local regulations) after the last dose of RBV
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 146
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Participants who have been previously exposed to anti-HCV treatment, including any approved or investigational direct-acting antiviral (DAA) therapy
- Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson?s disease, ?1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
- Participant is infected with hepatitis B virus (hepatitis B surface antigen [HBsAg] positive) or human immunodeficiency virus (HIV-1 or HIV-2) (HIV-1 or HIV-2 antibody test positive at screening)
- Participant is infected with non-genotype 1 HCV
- Participant has advanced liver disease equivalent to Metavir status F3-F4 (bridging fibrosis or cirrhosis)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To determine the efficacy of TMC435 plus PegIFNalfa-2a and RBV when administered for 12 weeks in treatment-naïve subjects with chronic genotype 1 HCV infection, as measured by the proportion of subjects with sustained virologic response 12 weeks after planned end of treatment (SVR12).<br>- To assess the safety and tolerability of TMC435 plus PegIFNalfa-2a and RBV when administered for 12 weeks in treatment-naïve subjects with the chronic genotype 1 HCV infection;Secondary Objective: See section 2.1 - Objectives - Major Secondary Objectives, p33 of the Clinical Trial Protocol;Primary end point(s): The number of participants with sustained virologic response 12<br>weeks after planned end of treatment (SVR12).;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method

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