Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03112044 | Lung Transplant HCV, Pilot Study | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 26 | — | — | Sep 19, 2017 | May 31, 2026 | Apr 3, 2025 | 1 | Canada |
Safety of transplantation using HCV positive donors reflected by 6 month survival and being free of HCV by PCR (either due to lack of transmission or as a result of treatment).
| Arm | Type | Description |
|---|---|---|
| HCV+ lung transplant to HCV- recipients | EXPERIMENTAL | HCV+ donor lungs will be treated with Normothermic Ex Vivo Lung Perfusion (EVLP) in order to reduce viral load and minimize risk of HCV transmission. Patients who become viremic defined as at least two consecutive positive samples will receive sofosbuvir/velpatasvir 400 mg/100 mg (Epclusa) for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Sofosbuvir-velpatasvir (400 mg/100 mg) | DRUG | Patients will have standard monitoring with HCV RNA and liver panel assessment at 2 week intervals until HCV is undetectable and then at the end of treatment and 3 and 6 months following its completion. Post-operative transplant care and immunosuppression will be carried on as usual transplant practice at Toronto General Hospital. |
| Ex Vivo Lung Perfusion (EVLP) | DEVICE | Normothermic EVLP is a method of donor lung preservation, assessment, treatment, and repair of injured organs. This method allows donor lungs to be treated for at least 12h under protective physiological conditions. |
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