UPMC
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT03377478
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Pittsburgh, Pennsylvania, 15213, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
Other names: Procedure, Sofosbuvir/velpatasvir
Time frame: at 2 years
Incidence of HCV Viremia
Time frame: at 2 years
Rate of HCV seroconversion
Time frame: at 2 years
Assessment of Hepatic function
Time frame: at 2 years
Survival rates
Time frame: at 2 years
The incidence of rejection
Time frame: at 2 years
Time on waitlist will be assessed
Pablo Sanchez
Other
Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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