Expanding the Pool in Lung Transplantation

Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Lung Transplant
• Intervention / Treatment: Drug: Epclusa

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lung Transplant; 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).	Drug: Epclusa; Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.; Other Names: Procedure; Sofosbuvir/velpatasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV Viremia	Incidence of HCV Viremia	at 2 years
Seroconversion	Rate of HCV seroconversion	at 2 years
Liver Function Testing	Assessment of Hepatic function	at 2 years
Survival	Survival rates	at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rejection	The incidence of rejection	at 2 years
Waitlist	Time on waitlist will be assessed	at 2 years

Collaborators and Investigators

• Sponsor: Pablo Sanchez
• Investigators: Principal Investigator: Pablo Sanchez, MD, Assistant Professor of Surgery/University of Pittsburgh

Publications and helpful links

Helpful Links

• Sofosbuvir
• Drug Information

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2019
• Primary Completion (ACTUAL): September 21, 2021
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (ACTUAL): December 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
• Other Study ID Numbers: STUDY19030435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No