Status:
COMPLETED
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
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 genoty...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2016
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT02251717
Start Date
October 14 2014
End Date
June 16 2016
Last Update
November 19 2018
Active Locations (5)
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1
Vienna, Austria
2
Marseille, France
3
Paris, France
4
Hanover, Germany