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

Phase 1

• Conditions: Hepatitis C Virus (HCV) genotype-1 infection; MedDRA version: 16.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-004905-29-IT
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-30
• Last Update Posted: 7 January 2019

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, a1-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