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

NCT02728206 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: GS-US-342-2083
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (2)

• 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

• Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

  Up to Week 4

Secondary Outcomes (3)

• Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

  Posttreatment Week 4

• Percentage of Participants With HCV RNA < LLOQ On Treatment

  Days 3, 5, 7, 14, 21, and 28

• Percentage of Participants With Overall Virologic Failure

  Up to Posttreatment Week 12

Study Arms (1)

SOF/VEL

EXPERIMENTAL

SOF/VEL FDC for 4 weeks starting on the day of or day after the participant's liver transplant

Drug: SOF/VEL

Interventions

SOF/VEL DRUG

400/100 mg FDC tablet administered orally once daily

Also known as: GS-7977/GS-5816, Epclusa®

SOF/VEL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Receiving an HCV-infected liver
• HIV or hepatitis B virus (HBV) co-infected

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Unknown Facility

Auckland, New Zealand

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 5, 2016
• Study Start: June 12, 2016
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: February 6, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

NZ (1)