Overview

Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease

Status:
Completed
Trial end date:
2019-02-14
Target enrollment:
0
Participant gender:
All
Summary
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 HCV infection who are on dialysis for ESRD.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Sofosbuvir
Criteria
Key Inclusion Criteria:

- Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/
nonlactating females aged 18 years or older who are on dialysis for ESRD, including
adults with HIV coinfection 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.