Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
Status:
Completed
Trial end date:
2017-10-19
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 2
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ledipasvir Ledipasvir, sofosbuvir drug combination Ribavirin Sofosbuvir