Expanding the Pool in Lung Transplantation

  • STATUS
    Recruiting
  • End date
    Feb 1, 2026
  • participants needed
    20
  • sponsor
    Pablo Sanchez
Updated on 10 February 2021
epclusa

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.

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).

Details
Condition Lung transplant, Hepatitis C, Hepatitis C virus, lung transplantation
Treatment Epclusa
Clinical Study IdentifierNCT03377478
SponsorPablo Sanchez
Last Modified on10 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Hepatitis C virus or Lung transplant or Hepatitis C?
Do you have any of these conditions: Hepatitis C virus or lung transplantation or Hepatitis C or Lung transplant?
Do you have any of these conditions: lung transplantation or Hepatitis C virus or Lung transplant or Hepatitis C?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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