Expanding the Pool in Lung Transplantation

Pablo Sanchez

Status and phase: Completed; Phase 1

Conditions: Lung Transplant; Hepatitis C

Treatments: Drug: Epclusa

Study type: Interventional

Funder types: Other

Identifiers

NCT03377478

STUDY19030435

Details and patient eligibility

About

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.

Full description

The investigators are proposing a study of efficacy, in which positive donors will be used for HCV negative patients. Following lung transplantation patients will undergo HCV antibody, virus PCR, and liver function testing. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Sofosbuvir/velpatasvir therapy.

This initial study would enroll 20 patients and utilize donors that are young, otherwise healthy whom are Hepatitis C antibody positive but Nucleic Acid Amplification Testing (NAT) negative (HCV Ab+/NAT-). The recipients would be limited to those patients who have previously consented to receive a high risk lung transplant, consented to participant in this study, and who are physiologically optimized for transplantation (e.g., low risk for lung transplantation).

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Lung Transplant

Experimental group

Description:

Patients will be transplanted with HCV positive lung. Recipients whom test positive for HCV viremia for 2 consecutive tests at any point will complete 12 weeks of Epclusa (Sofosbuvir/velpatasvir).

Treatment:

Drug: Epclusa