Lung Transplant HCV, Pilot Study

• Status: Active, not recruiting
• Trial end date: 2022-04-17
• Target enrollment: 0
• Participant gender: All

Summary

In this study HCV negative recipients will be transplanted with HCV positive lungs. Investigators will attempt to decrease infectivity rates by performing Normothermic Ex vivo Lung Perfusion (EVLP), which is an approved method of donor lung preservation, assessment and treatment, and could be an excellent platform to reduce/eliminate hepatitis C virus. Patients will be treated by the standard approved direct-acting antivirals (DAAs) if infection occurs. It is planned to enrolled 20 patients from the Lung transplant wait list in this study. Patients will be followed for 6 months. This will be a single center pilot study.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marcelo Cypel; University Health Network, Toronto
• Collaborators: Gilead Sciences; University Health Network, Toronto
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Inclusion Criteria:

• Recipients listed for single or bilateral lung transplant

• HCV Nucleic Acid Amplification Testing (NAT) negative

• Ability to provide written informed consent

Exclusion Criteria:

• Participation in another interventional clinical trial