Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency

Completed · Phase 2

Conditions studied: HCV Infection

In brief

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).

Key facts

Study ID

NCT01958281

Run by

Gilead Sciences

People needed

38

Starts

2013-10-07

Expected to finish

2017-10-19

Last updated by the study team

2018-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — San Francisco, California, United States
• Study site — Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Detroit, Michigan, United States
• Study site — Rochester, New York, United States
• Study site — San Antonio, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Grafton, Auckland, New Zealand
• Study site — Christchurch, New Zealand
• Study site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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