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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mavyret
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Post Lung Transplant Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 11, 2018
Last Updated
September 1, 2021
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03523871
Brief Title
A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 12, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post Lung Transplant Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mavyret
Other Intervention Name(s)
pibrentasvir, glecaprevir
Intervention Description
Patients will be on 8 weeks of Mavyret
Primary Outcome Measure Information:
Title
Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C
Description
Surveillance for the development of hepatitis C viremia post-transplant
Time Frame
24 Months
Title
Number of Patients With Sustained Virologic Response After Treatment
Description
HCV serologic testing to evaluate the presence of immunity to HCV or the evidence of prior infection with HCV.
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Angel, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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