Status:
COMPLETED
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis C Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, ...
Detailed Description
Part 1: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily with weight-based RBV for 12 weeks. Participants will be randomized in equal proportions to: no PEG (Arm 1), PEG for 4 week...
Eligibility Criteria
Inclusion
- Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL
- Not co-infected with HIV
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion
- History of any other clinically significant chronic liver disease
- Pregnant or nursing female or male with pregnant female partner
- History of significant drug allergy to nucleoside/nucleotide analogs.
- Participation in a clinical study within 3 months prior to first dose
- Positive result for significant drug use at Screening
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT01260350
Start Date
December 1 2010
End Date
December 1 2013
Last Update
November 17 2014
Active Locations (2)
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1
Auckland Clinical Studies Ltd.
Auckland, New Zealand
2
Christchurch Clinical Studies Trust
Christchurch, New Zealand