A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Mavyret

• Registration Number: NCT03523871
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-05-10
• Study Start: 2018-05-12
• Study First Posted: 2018-05-14
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Results First Submitted: 2021-08-09
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Results First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post Lung Transplant Patients	Mavyret	The lung transplantation will be performed per standard of care techniques,and all post-transplant management of the transplanted organ, including immunosuppression, will be carried out per standard of care.

Primary Outcome Measures

Name	Time	Method
Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C	24 Months	Surveillance for the development of hepatitis C viremia post-transplant
Number of Patients With Sustained Virologic Response After Treatment	24 Months	HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States