Recruiting

Hepatitis C Positive Organs

Sponsor:

Brigham and Women's Hospital

Code:

NCT03086044

Conditions

Hepatitis C

Awaiting Organ Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sofosbuvir/velpatasvir

Monitoring

Study Details

Brief summary:

This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).

Conditions

Hepatitis C

Awaiting Organ Transplant

Study ID

NCT03086044

Start date

Mar 1, 2017

Status verified date

Oct, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and women who are age ≥ 18 years
  • Active on either the cardiac, lung, or kidney transplant waiting list
  • Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection

Exclusion Criteria:

  • Hepatitis B NAT or viral load positive
  • Evidence of cirrhosis or clinically significant liver disease

Study Design

Enrollment

148 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HCV NAT Positive Donor

Intervention: 2 week treatment course with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily

Participants who receive allografts from a donor who is HCV NAT positive will receive treatment with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily, beginning on the day of transplant.

experimental: HCV NAT Negative, HCV Ab Positive Donor

Intervention: HCV viral load monitoring

Participants who receive allografts from a donor who is HCV Ab positive and NAT negative will have close serial HCV viral load monitoring and will be treated with a direct acting antiviral, 400mg / velpatasvir 100mg daily, for 6 weeks if HCV viremia develops.

Interventions

Sofosbuvir/velpatasvir

2 weeks of treatment beginning on the day of transplant

Monitoring

Close HCV viral load monitoring Will receive direct acting antiviral treatment with 6 weeks of sofosbuvir/velpatasvir if the recipient develops HCV viremia during the post-transplant HCV viral load testing

Primary outcome measure

  • Graft survival [ Time Frame: 6 months post-transplant ]
  • HCV status of the transplant recipient [ Time Frame: 6 months post-transplant ]

Central Contacts and Locations

Central contacts

Ann Woolley, MD

617-732-5500awoolley@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ann Woolley, MD

617-525-8418awoolley@partners.org

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 12, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2022-10-12.