A 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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mavyret

Drug

Patients will be on 8 weeks of Mavyret

Other names: pibrentasvir, glecaprevir

Primary outcomes

Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C

Time frame: 24 Months

Surveillance for the development of hepatitis C viremia post-transplant
Number of Patients With Sustained Virologic Response After Treatment

Time frame: 24 Months

HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: May 14, 2018
Registry last updated: Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.

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