Expanding the Pool in Lung Transplantation
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/7/2018 |
| Start Date: | April 1, 2019 |
| End Date: | February 1, 2020 |
| Contact: | Jonathan D'Cunha, MD, PhD |
| Email: | dcunhaj@upmc.edu |
| Phone: | 412-648-6315 |
Expanding the Pool in Lung Transplantation: The Use of Hepatitis C Positive Donor Lungs in Hepatitis C Negative Recipients
To perform a study (100 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.
for hepatitis C negative recipients with post-operative surveillance and treatment only if a
recipient infection occurs.
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).
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).
Inclusion Criteria:
- 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 Criteria:
- 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
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