Transplanting Hepatitis C Lungs Into Negative Lung Recipients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    10
  • sponsor
    University of Pennsylvania
Updated on 24 January 2021
FIO2
lung transplant

Summary

This study is being conducted to determine safety and effectiveness of transplanting lungs from Hepatitis C-positive donors into Hepatitis C-negative patients on the lung transplant waitlist, who will then be treated with appropriate direct-acting antiviral (DAA) after transplantation.

Description

Open-labelled pilot clinical trial of Zepatier (Grazoprevir + Elbasvir), Epclusa (Sofosbuvir + Velpatasvir), or another appropriate DAA in at least 10 HCV-negative subjects receiving a lung transplant from a hepatitis C (HCV)-positive donor. Eligible subjects will receive a lung transplant from a deceased-donor, and then will receive treatment after lung transplantation when infection with HCV is confirmed in these lung transplant recipients. Treatment will be complete after 12 weeks for most subjects.

Details
Condition Pulmonary Disease, Lung Disease, pulmonary diseases, lung diseases, pulmonary disorders
Treatment Zepatier, Epclusa
Clinical Study IdentifierNCT03724149
SponsorUniversity of Pennsylvania
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 67 yrs?
Gender: Male or Female
Do you have any of these conditions: Pulmonary Disease or Lung Disease?
Do you have any of these conditions: Lung Disease or pulmonary diseases or Pulmonary Disease or pulmonary disorders or lung diseases?
Detectable HCV RNA
Age 55 years
PaO2/FiO2 300 on FiO2 = 100% and PEEP=5
Cigarette use history 20 pack years
No evidence of cirrhosis
No prior treatment of HCV with a DAA-based therapy
Can be isolated hepatitis B Core IgG positive, but cannot have a detectable HBV Core IgM, HBSAg, and/or HBV DNA (positive HBV NAT test)

Exclusion Criteria

Donation after circulatory death determination (DCDD)
HIV positive
Clear my responses

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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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