Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/28/2019 |
| Start Date: | June 27, 2017 |
| End Date: | February 13, 2019 |
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects With Genotype 1, 4, 5 and 6 Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease
The primary objectives of this study are to evaluate the safety, efficacy and tolerability of
treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic hepatitis C virus (HCV)
infection who are on dialysis for End Stage Renal Disease (ESRD).
treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic hepatitis C virus (HCV)
infection who are on dialysis for End Stage Renal Disease (ESRD).
Key Inclusion Criteria:
- Chronic HCV infected genotype 1, 4, 5, or 6 male and non-pregnant/ non-lactating
females aged 18 years or older who are on dialysis for ESRD, including adults with HIV
co-infection if they are suppressed on a stable, protocol-approved antiretroviral
(ARV) regimens for ≥8 weeks prior to screening.
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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