A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/25/2018 |
| Start Date: | May 12, 2018 |
| End Date: | June 2020 |
| Contact: | Cecilia Deterville, MS |
| Email: | Cecilia.Deterville@nyumc.org |
| Phone: | 646-315-3008 |
A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
Patients who are Hepatitis C Negative (HCV negative) and are on the waiting list for a lung
transplant at NYULH who consent to participate in this study will receive a lung transplant
from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the
pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week
treatment course. Patients will be monitored post-transplant for the development of viremia,
and for the time course of clearance of viremia among those who develop viremia.
transplant at NYULH who consent to participate in this study will receive a lung transplant
from a deceased donor that is HCV positive. Patients will initiate treatment for HCV with the
pan-genotypic agent, Mavyret, on the day of surgery and will complete the full 8-week
treatment course. Patients will be monitored post-transplant for the development of viremia,
and for the time course of clearance of viremia among those who develop viremia.
Inclusion Criteria:
Recipient criteria:
- Listed for an isolated lung transplant at NYU Langone Health
- Between 18-70 years of age
- Able to travel to the NYU Langone Health for routine post-transplant visits and study
visits for a minimum of 6 months after transplantation
- No active illicit substance abuse
- Weight at least 40kg
- Women of childbearing potential must agree to use birth control in accordance with
Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to
the increased risk of birth defects and/or miscarriage
- Both men and women must agree to use at least one barrier method after transplant to
prevent any secretion exchange
- Able and willing to provide informed consent
Donor criteria:
- Detectable HCV RNA by nucleic acid test (NAT) or positive anti-HCV antibody
- Donor lung meets standard NYU Langone Health clinical criteria for procurement
Exclusion Criteria:
Recipient criteria:
- HIV positive
- HCV RNA positive or history of previously treated HCV
- Evidence of active hepatitis B infection or on active antiviral treatment for HBV
- Pregnant or nursing (lactating) women
- Use of strong CYP3A inducers
- Requires multi-organ transplant
Donor criteria:
- Confirmed HIV positive
- Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable
Hepatitis B virus DNA)
- Known previously failed treatment for HCV
- Donor age >60 years
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Luis Angel, MD
Phone: 646-315-3008
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