A study to evaluate the effects of the combination of 4 oral antiviral agents for the treatment of patients infected with the Hepatitis C Virus (HCV).

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Genotype 1 Hepatitis C Virus Infection; MedDRA version: 14.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-000944-43-DE
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-06
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Willing and able to provide written informed consent.
2. Male or female, aged from 18 to 70 years old, inclusive.
3. Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
4. Subjects must have a liver biopsy performed = 2 years prior to Screening indicating the
absence of cirrhosis.
5. Monoinfection with HCV GT 1a or 1b.
6. HCV treatment naïve
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1. Pregnant female or male with pregnant female partner.
2. Poorly-controlled diabetes mellitus
3. History of clinically significant hemoglobinopathy
4. History of clinically significant retinal disease
5. History of invasive malignancy diagnosed or treated within 5 years
6. Untreated or significant psychiatric illnesses
7. Co-infection with HBV or HIV
12. Known cirrhosis
13. Chronic liver disease of a non-HCV etiology
14. History of solid organ transplantation
15. Suspicion of hepatocellular carcinoma

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified