Transplanting Hepatitis C Positive Organs

NCT ID: NCT03086044

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2023-12-31

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.

Conditions

Hepatitis C; Awaiting Organ Transplant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sofosbuvir/velpatasvir

Intervention Type: DRUG

2 weeks of treatment beginning on the day of transplant

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.

Group Type: EXPERIMENTAL

Sofosbuvir/velpatasvir

Intervention Type: DRUG

2 weeks of treatment beginning on the day of transplant

Monitoring

Intervention Type: OTHER

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

Interventions

Sofosbuvir/velpatasvir

2 weeks of treatment beginning on the day of transplant

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

Epclusa; Sofosbuvir/velpatasvir (Epclusa)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lindsey R. Baden, MD

Associate Professor at Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsey Baden, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ann Woolley, MD

Role: CONTACT

awoolley@bwh.harvard.edu

617-732-5500

Facility Contacts

Ann Woolley, MD

Role: primary

awoolley@partners.org

617-525-8418

References

Woolley AE, Singh SK, Goldberg HJ, Mallidi HR, Givertz MM, Mehra MR, Coppolino A, Kusztos AE, Johnson ME, Chen K, Haddad EA, Fanikos J, Harrington DP, Camp PC, Baden LR; DONATE HCV Trial Team. Heart and Lung Transplants from HCV-Infected Donors to Uninfected Recipients. N Engl J Med. 2019 Apr 25;380(17):1606-1617. doi: 10.1056/NEJMoa1812406. Epub 2019 Apr 3.

Reference Type: DERIVED

PMID: 30946553 (View on PubMed)

Other Identifiers

2016-P001170

Identifier Type: -

Identifier Source: org_study_id