Status:
COMPLETED
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotyp...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent
- HCV RNA ≥ 10\^4 IU/mL at screening
- HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
- Classification as treatment naive or treatment experienced
- Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Exclusion
- Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
- Screening ECG with clinically significant abnormalities
- Laboratory results outside of acceptable ranges at Screening
- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
741 Patients enrolled
Trial Details
Trial ID
NCT02201940
Start Date
July 1 2014
End Date
September 1 2015
Last Update
November 15 2018
Active Locations (80)
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1
Little Rock, Arkansas, United States
2
Long Beach, California, United States
3
Los Angeles, California, United States, 90027
4
Los Angeles, California, United States, 90036