Overview

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

Status:
Completed
Trial end date:
2018-11-07
Target enrollment:
0
Participant gender:
All
Summary
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Velpatasvir
Criteria
Key Inclusion Criteria:

- Chronic HCV infected, 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) regimen for ≥8 weeks
prior to screening.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.