Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

• Status: Completed
• Trial end date: 2016-06-16
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Key Inclusion Criteria:

• Genotype 1 or 4 chronic HCV infection

• Have received a kidney transplant more than 6 months before the Baseline visit

• Cirrhosis determination

• Screening laboratory parameters within defined thresholds

• Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner

• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain -resolved skin cancers)

• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

• Planned or anticipated second kidney transplant

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