Status:
COMPLETED
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Hepatitis C Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 week...
Eligibility Criteria
Inclusion
- Age \> 18, with chronic genotype 1 HCV infection
- HCV treatment-naive
- HCV RNA \> 10,000 IU/mL at screening
- Screening laboratory values within defined 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
- Presence of cirrhosis
- Coinfection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
647 Patients enrolled
Trial Details
Trial ID
NCT01851330
Start Date
May 1 2013
End Date
March 1 2014
Last Update
November 16 2018
Active Locations (52)
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1
Birmingham, Alabama, United States
2
La Jolla, California, United States
3
Los Angeles, California, United States
4
Palo Alto, California, United States