Status:
COMPLETED
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.
Eligibility Criteria
Inclusion
- Chronic genotype 2 HCV-infection
- Male or female, age ≥ 20 years
- Body weight ≥ 40 kg
- HCV RNA ≥ 10,000 IU/mL at screening
Exclusion
- Current or prior history of clinically significant illness other than HCV
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01910636
Start Date
February 1 2013
End Date
June 1 2014
Last Update
March 24 2015
Active Locations (19)
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1
Akita, Japan
2
Chiba, Japan
3
Chiyoda-ku, Japan
4
Gifu, Japan