Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir Fixed Dose Combination Administered for Four Weeks in Patients Infected With Chronic HCV in the Peri-Operative Liver Transplantation Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02728206
• Other study ID #: GS-US-342-2083
• Status: Completed
• Phase: Phase 2
• Start date: June 12, 2016
• Est. completion date: January 16, 2018

Study information

• Verified date: February 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 16, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver transplantation

Key Exclusion Criteria:

• Receiving an HCV-infected liver

• HIV or hepatitis B virus (HBV) co-infected

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• SOF/VEL
400/100 mg FDC tablet administered orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event		Up to Week 4
Secondary	Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With HCV RNA < LLOQ On Treatment		Days 3, 5, 7, 14, 21, and 28
Secondary	Percentage of Participants With Overall Virologic Failure	Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA = 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA = 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA < 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.	Up to Posttreatment Week 12