Transplanting Hepatitis C Positive Organs

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03086044
• Other study ID #: 2016-P001170
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2017
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Brigham and Women's Hospital
• Contact: Ann Woolley, MD
• Phone: 617-732-5500
• Email: awoolley[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Awaiting Organ Transplant
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft survival	Functioning allograft not requiring mechanical support	6 months post-transplant
Primary	HCV status of the transplant recipient	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)	6 months post-transplant
Secondary	Treatment related adverse events	Number of treatment related adverse events per patient using direct-acting antiviral HCV regimens in post transplant recipients	6 months post-transplant