A study with GS-7977 + Ribavirin with or without Peginterferon Alfa-2a for patients with chronic Hepatitis C infection who previously took part in Gilead-sponsored studies for Hepatitis C.

• Conditions: Chronic HCV Infection; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-000571-16-CZ
• Lead Sponsor: Gilead Sciences Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-19
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Willing and able to provide written informed consent
2. Chronic HCV
3. Subject must have participated in a prior Gilead HCV study
4. HCV RNA >LLOQ
5. Screening ECG without clinically significant abnormalities
6. Subjects must have a number of laboratory parameters within defined ranges at screening
7. A female subject is eligible to enter the study if it is confirmed that she is:
a) Not pregnant or nursing
b) Of non-childbearing potential
c) Of childbearing potential but with a negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 visit prior to randomization and agree to one of the described forms of contraception during the course of the study and up to 7 months following cessation of Ribavirin therapy.
8. All male study participants must agree to consistently and correctly use a condom while their female partner agrees to use 1 of the methods of birth control listed in the protocol from the date of screening until 7 months after their last dose of RBV.
9. Male subjects must agree to refrain from sperm donation for at least 7 months after the last dose of RBV.
10. Subject must be of generally good health as determined by the Investigator.
11. Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
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 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Pregnant or nursing female or male with pregnant female partner
2. Current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage).
3. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
4. Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day)
5. Active substance abuse which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study.
6. Use of any prohibited concomitant medications as described in the protocol within 28 days of the Baseline/Day 1 visit

Study & Design

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