Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Infectious Disease, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2018 |
| Start Date: | October 7, 2013 |
| End Date: | October 19, 2017 |
A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 and Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 Weeks in Genotype 1 or 4 HCV Infected Subjects With Renal Insufficiency
The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir
(SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and
to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in
participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic
renal insufficiency (impaired kidney function).
(SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and
to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in
participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic
renal insufficiency (impaired kidney function).
Key Inclusion Criteria:
- Cohorts 1 and 2: chronic genotype 1 or 3 HCV infection
- Cohort 3: chronic genotype 1 or 4 HCV infection
- HCV RNA ≥ 10^4 IU/mL at screening
- Screening labs within defined thresholds
- Cirrhosis determination at screening
Key Exclusion Criteria:
- Females who are pregnant or nursing or males who have a pregnant partner
- Prior null response to pegylated interferon (Peg-IFN)+RBV therapy (Cohorts 1 and 2) or
for individuals with cirrhosis, prior treatment failure with IFN-based therapy not
resulting from treatment intolerance (Cohort 3)
- Current of prior history of hepatic decompensation
- Infection with hepatitis B virus (HBV) or HIV
- History of clinically significant illness (including psychiatric or cardiac) or any
other medical disorder that may interfere with individual's treatment and/or adherence
to the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
8
sites
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