Transplanting Hepatitis C Positive Thoracic Organs

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, pilot safety and efficacy trial for adults who are active on the heart or lung 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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Inclusion Criteria:

• Men and women who are age ≥ 18 years

• Active on either the cardiac or lung 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:

• HIV antibody or HIV NAT positive

• Hepatitis B surface antigen or Hepatitis B NAT or viral load positive

• Evidence of cirrhosis or clinically significant liver disease