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

• Status: Completed
• Trial end date: 2016-04-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

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.