Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
Completed · Phase 2
Conditions studied: Chronic HCV Infection
In brief
This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).
Key facts
- Study ID
- NCT01984294
- Run by
- Gilead Sciences
- People needed
- 101
- Starts
- 2013-10-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2018-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18, with chronic genotype 1 HCV infection
- Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen
- HCV RNA > 10,000 IU/mL at Screening
- Presence of compensated cirrhosis
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
You may not qualify if…
- Pregnant or nursing female or male with pregnant female partner
- Co-infection 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
Where it is running
- Study site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.