NCT03086044

Transplanting Hepatitis C Positive Organs

Transplanting Organs From Hepatitis C Positive Donors to Hepatitis C Uninfected Recipients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.

Conditions

• Hepatitis C
• Awaiting Organ Transplant

Interventions

Type	Name	Description
DRUG	Sofosbuvir/velpatasvir	2 weeks of treatment beginning on the day of transplant
OTHER	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

Timeline

• Start date: 2017-03-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2017-03-22
• Last updated: 2022-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study