Clinical trial NCT02251717: 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
Official title: A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Keywords: renal transplant
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-09-29
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.


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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Wien
country: Austria
city: Marseille
country: France
city: Paris
country: France
city: Hannover
country: Germany
city: Milan
country: Italy
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Colombo M, Aghemo A, Liu H, Dvory-Sobol H, Hyland RH, Yun C, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients With Chronic Genotype 1 or 4 HCV Infection. Journal of Hepatology. 2016;64 pp S183-S212. (GS 13, oral presentation).
citation: Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15.