Status:
COMPLETED
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype ...
Eligibility Criteria
Inclusion
- Confirmed chronic genotype 1 or 3 HCV infection
- HCV treatment-naive
- Individuals will have cirrhosis status assessment; liver biopsy may be required.
- Screening laboratory values within predefined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion
- Pregnant or nursing female or male with pregnant female partner
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Contraindication to ribavirin therapy
- Excessive alcohol ingestion as defined by protocol
- History of solid organ transplantation
- Current or prior history of clinical hepatic decompensation
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01896193
Start Date
June 1 2013
End Date
June 1 2014
Last Update
May 29 2015
Active Locations (16)
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1
Central Clinical Hospital of the Russian Academy of Sciences
Moscow, Russia
2
Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor
Moscow, Russia
3
Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department
Moscow, Russia
4
City Clinical Hospital 24
Moscow, Russia