Clinical trial NCT02350569: Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting
Official title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Keywords: liver transplant
hepatitis C
Gilead
Communicable Diseases
Infection
Liver Diseases
RNA Virus Infections
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-01-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.


Eligibility criteria: Key Inclusion Criteria:

* Willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
* HCV RNA infection with quantifiable virus at screening
* Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
* Currently on the liver transplantation wait list
* Screening electrocardiogram (ECG) without clinically significant abnormalities.
* A negative serum pregnancy test result is required for females

Key Exclusion Criteria:

* Any previous solid organ transplant
* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
* HIV infection or a positive hepatitis B virus surface antigen result
* History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
* Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
* Prior exposure to an HCV non-structural protein (NS)5A inhibitor
* Patients on hemodialysis prior to or at the time of transplantation will be excluded
* Creatinine clearance (CLcr) \< 40 mL/min at screening or \< 40 mL/min on day of transplant
* Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
* Receipt or planned receipt of an organ from an HCV positive donor

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 Prematurely Discontinued Study Drug Due to an Adverse Event
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With Virologic Failure
timeFrame: Up to Posttreatment Week 12
measure: Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28
timeFrame: Days 1, 3, 5, 7, 14, 21, and 28
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Levitsky J, Verna EC, O'Leary JG, Bzowej NH, Moonka DK, Hyland RH, Arterburn S, Dvory-Sobol H, Brainard DM, McHutchison JG, Terrault NA. Perioperative Ledipasvir-Sofosbuvir for HCV in Liver-Transplant Recipients. N Engl J Med. 2016 Nov 24;375(21):2106-2108. doi: 10.1056/NEJMc1611829. No abstract available.