Phase 2
Completed N=114
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
Source: ClinicalTrials.gov NCT02251717 ↗Enrolled (actual)
114
Serious AEs
11.4%
Results posted
Nov 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 100.0; 100.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
100.0; 100.0 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
1.8; 0 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Virologic Failure |
0; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02251717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.