Transplanting Hepatitis C Positive Organs

Phase 4

Recruiting

• Conditions: Hepatitis C; Awaiting Organ Transplant
• Interventions: Drug: Sofosbuvir/velpatasvir; Other: Monitoring

• Registration Number: NCT03086044
• Lead Sponsor: Brigham and Women's Hospital

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).

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.

Study Timeline

• Study First Submitted: 2016-09-12
• Study Start: 2017-03-01
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCV NAT Positive Donor	Sofosbuvir/velpatasvir	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.
HCV NAT Negative, HCV Ab Positive Donor	Monitoring	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.
HCV NAT Negative, HCV Ab Positive Donor	Sofosbuvir/velpatasvir	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.

Primary Outcome Measures

Name	Time	Method
Graft survival	6 months post-transplant	Functioning allograft not requiring mechanical support
HCV status of the transplant recipient	6 months post-transplant	Sustained virologic response (SVR) 12 weeks after HCV treatment completion in Arm A or at 6 months in Arm B (SVR defined as HCV RNA \< lower limit of quantification)

Secondary Outcome Measures

Name	Time	Method
Treatment related adverse events	6 months post-transplant	Number of treatment related adverse events per patient using direct-acting antiviral HCV regimens in post transplant recipients

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States