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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: LDV/SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02251717

2014-002121-35 (EudraCT Number)

GS-US-337-1406

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

LDV/SOF 12 wk

Experimental group

Description:

Participants will receive LDV/SOF FDC for 12 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF 24 wk

Experimental group

Description:

Participants will receive LDV/SOF FDC for 24 weeks.

Treatment:

Drug: LDV/SOF