A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipi… (NCT03523871) | Clinical Trial Compass
CompletedPhase 2
A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
United States20 participantsStarted 2018-05-12
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C
Timeframe: 24 Months
2
Number of Patients With Sustained Virologic Response After Treatment