Expanding the Pool in Lung Transplantation

• Status: Active, not recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To perform a study (20 patients) utilizing Hepatitis C positive (HCV Ab+/NAT -) donor lungs for hepatitis C negative recipients with post-operative surveillance and treatment only if a recipient infection occurs.

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

Details

• Lead Sponsor: Pablo Sanchez
• Treatments: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Inclusion Criteria:

• Patients who sign the informed consent for this study

• Patients whom agree to receive a PHS high risk organ

• Patients listed for heart transplantation

• Age 18-65

Exclusion Criteria:

• Patients who do not sign informed consent for this study

• HIV Seropositivity

• HBV Seropositivity (HBcAb and/or HBsAg positive)

• Abnormal liver enzymes - 3 times the normal liver function values (Bilirubin, INR, AST, ALT)

• Acute or chronic renal insufficiency (creatinine clearance <50 ml/min) or history of dialysis

• Patients on ECMO

• Respiratory insufficiency requiring mechanical respiratory support (ventilator, BiPAP)

• Liver insufficiency

• Prior history of hepatitis C

• Allergy to Sofosbuvir/velpatasvir

• Pregnancy