Status:
COMPLETED
Expanding the Pool in Lung Transplantation
Lead Sponsor:
Pablo Sanchez
Conditions:
Hepatitis C
Lung Transplant
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 infec...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03377478
Start Date
July 30 2019
End Date
April 1 2022
Last Update
December 16 2022
Active Locations (1)
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1
UPMC
Pittsburgh, Pennsylvania, United States, 15213