Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2019-07-30
2022-04-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
Epclusa
Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
Interventions
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Epclusa
Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients whom agree to receive a PHS high risk organ
* Patients listed for heart transplantation
* Age 18-65
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Pablo Sanchez
OTHER
Responsible Party
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Pablo Sanchez
Assistant Professor
Principal Investigators
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Pablo Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor of Surgery/University of Pittsburgh
Locations
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UPMC
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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Drug Information
Other Identifiers
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STUDY19030435
Identifier Type: -
Identifier Source: org_study_id