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Expanding the Pool in Lung Transplantation

Primary Purpose

Hepatitis C, Lung Transplant

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Epclusa

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UPMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung Transplant

Arm 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).

Outcomes

Primary Outcome Measures

HCV Viremia

Incidence of HCV Viremia

Seroconversion

Rate of HCV seroconversion

Liver Function Testing

Assessment of Hepatic function

Survival

Survival rates

Secondary Outcome Measures

Rejection

The incidence of rejection

Waitlist

Time on waitlist will be assessed

Full Information

NCT ID

NCT03377478

First Posted

December 14, 2017

Last Updated

December 15, 2022

Sponsor

Pablo Sanchez

1. Study Identification

Unique Protocol Identification Number

NCT03377478

Brief Title

Expanding the Pool in Lung Transplantation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

July 30, 2019 (Actual)

Primary Completion Date

September 21, 2021 (Actual)

Study Completion Date

April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Pablo Sanchez

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Lung Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lung Transplant

Arm Type

Experimental

Arm 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).

Intervention Type

Drug

Intervention Name(s)

Epclusa

Other Intervention Name(s)

Procedure, Sofosbuvir/velpatasvir

Intervention Description

Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.

Primary Outcome Measure Information:

Title

HCV Viremia

Description

Incidence of HCV Viremia

Time Frame

at 2 years

Title

Seroconversion

Description

Rate of HCV seroconversion

Time Frame

at 2 years

Title

Liver Function Testing

Description

Assessment of Hepatic function

Time Frame

at 2 years

Title

Survival

Description

Survival rates

Time Frame

at 2 years

Secondary Outcome Measure Information:

Title

Rejection

Description

The incidence of rejection

Time Frame

at 2 years

Title

Waitlist

Description

Time on waitlist will be assessed

Time Frame

at 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pablo Sanchez, MD

Organizational Affiliation

Assistant Professor of Surgery/University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://druginfo.nlm.nih.gov/drugportal/name/Sofosbuvir

Description

Sofosbuvir

URL

https://clinicaltrials.gov/ct2/info/fdalinks

Description

Drug Information

Learn more about this trial

Expanding the Pool in Lung Transplantation

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