NCT01958281

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

A Phase 2b, Open-Label Study of 200 mg or 400 mg Sofosbuvir+RBV for 24 Weeks in Genotype 1 or 3 and Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 Weeks in Genotype 1 or 4 HCV Infected Subjects With Renal Insufficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	SOF	Tablet(s) administered orally once daily
DRUG	RBV	200 mg tablet administered orally once daily
DRUG	LDV/SOF	90/400 mg fixed-dose combination (FDC) tablet administered orally once daily

Timeline

• Start date: 2013-10-07
• Primary completion: 2017-07-18
• Completion: 2017-10-19
• First posted: 2013-10-09
• Last updated: 2018-08-08
• Results posted: 2018-08-08

Locations

10 sites across 3 countries: United States, New Zealand, Puerto Rico

Regulatory

• FDA-regulated drug study