Expanding the Pool in Lung Transplantation

Phase 1

Completed

• Conditions: Lung Transplant; Hepatitis C
• Interventions: Drug: Epclusa

• Registration Number: NCT03377478
• Lead Sponsor: Pablo Sanchez

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-19
• Study Start: 2019-07-30
• Primary Completion: 2021-09-21
• Study Completion: 2022-04-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung Transplant	Epclusa	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).

Primary Outcome Measures

Name	Time	Method
HCV Viremia	at 2 years	Incidence of HCV Viremia
Liver Function Testing	at 2 years	Assessment of Hepatic function
Seroconversion	at 2 years	Rate of HCV seroconversion
Survival	at 2 years	Survival rates

Secondary Outcome Measures

Name	Time	Method
Rejection	at 2 years	The incidence of rejection
Waitlist	at 2 years	Time on waitlist will be assessed

Trial Locations

Locations (1)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States