Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/21/2018 |
| Start Date: | October 2013 |
| End Date: | July 2014 |
A Phase 2, Randomized, Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination With Ribavirin or GS-9669 250 mg or GS-9669 500 mg in Naive or Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
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).
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).
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
