Expanding the Pool in Lung Transplantation
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|ClinicalTrials.gov Identifier: NCT03377478|
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatits C Lung Transplant||Drug: Epclusa||Phase 1|
The investigators are proposing a proof of concept study 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 100 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: 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).
Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
- HCV Viremia [ Time Frame: at 2 years ]Incidence of HCV Viremia
- Seroconversion [ Time Frame: at 2 years ]Rate of HCV seroconversion
- Liver Function Testing [ Time Frame: at 2 years ]Assessment of Hepatic function
- Survival [ Time Frame: at 2 years ]Survival rates
- Rejection [ Time Frame: at 2 years ]The incidence of rejection
- Waitlist [ Time Frame: at 2 years ]Time on waitlist will be assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377478
|Contact: Jonathan D'Cunha, MD, PhDfirstname.lastname@example.org|
|Contact: Pablo Sanchez, MDemail@example.com|
|United States, Pennsylvania|
|UPMC||Not yet recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Jonathan D'Cunha, MD, PhD 412-648-6315 firstname.lastname@example.org|
|Contact: Pablo Sanchez, MD 412-648-6315 email@example.com|
|Principal Investigator:||Jonathan D'Cunha, MD, PhD||Associate Professor of Surgery/University of Pittsburgh|