A study with four oral anti-Hepatitis drugs in patients with Hepatitis C who have already had at least one round of treatment.

• Conditions: Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection; MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002748-28-DE
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-23
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Male or female, age = 18 years
3. Confirmation of chronic HCV infection
4. Subjects must have a liver biopsy performed = 3 years prior to screening indicating the
absence of cirrhosis
5. Monoinfection with HCV GT 1a or 1b
6. HCV RNA = 104 IU/mL at screening
7. Prior treatment and adherence with one course of pegylated interferon alfa and 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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1. Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up
2. Prior treatment of HCV with any direct-acting antiviral or other interferons (whether approved or experimental)
3. Pregnant or nursing female or male with pregnant female partner
4. History of significant cardiac disease
5. Presence of autoimmune disorders
6. Known cirrhosis
7. Chronic liver disease of a non-HCV etiology
8. Poorly-controlled diabetes mellitus
9. Untreated or significant psychiatric illnesses
10. Severe chronic obstructive pulmonary disease

Study & Design

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