Back to resultsPan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Primary Purpose
Respiratory Failure, Hepatitis C
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Failure focused on measuring Lung disease, Lung Transplant, HCV, Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Met MGH transplant center criteria, listed for lung transplant
- Able to sign informed consent
Exclusion Criteria:
- Pregnant or nursing (lactating) women
- HIV positivity
- Any contra-indication to lung transplantation per center protocol
- For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
- For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Direct Acting Antiviral for HCV
Arm Description
8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)
Outcomes
Primary Outcome Measures
Undetectable Blood HCV RNA Level
Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.
Secondary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events
Safety and tolerability of DAA therapy in the lung transplant recipient monitored by quantifying the number of treatment related adverese events per patient and evaluation clinically significant out of range lab results as compared to baseline/pretreatment values per patient
Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)
Tolerability of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results
Full Information
NCT ID
NCT03625687
First Posted
July 30, 2018
Last Updated
April 4, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03625687
Brief Title
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Official Title
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding, transitioned to standard of care
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
Detailed Description
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve recipient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Hepatitis C
Keywords
Lung disease, Lung Transplant, HCV, Hepatitis C
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Direct Acting Antiviral for HCV
Arm Type
Experimental
Arm Description
8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)
Intervention Type
Drug
Intervention Name(s)
Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks
Other Intervention Name(s)
DAA treatment, Mavyret, Epclusa
Intervention Description
8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)
Primary Outcome Measure Information:
Title
Undetectable Blood HCV RNA Level
Description
Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.
Time Frame
12 weeks post last dose of treatment with DAA
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events
Description
Safety and tolerability of DAA therapy in the lung transplant recipient monitored by quantifying the number of treatment related adverese events per patient and evaluation clinically significant out of range lab results as compared to baseline/pretreatment values per patient
Time Frame
8 weeks
Title
Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)
Description
Tolerability of commercially available DAA therapy in the lung transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant laboratory results
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Met MGH transplant center criteria, listed for lung transplant
Able to sign informed consent
Exclusion Criteria:
Pregnant or nursing (lactating) women
HIV positivity
Any contra-indication to lung transplantation per center protocol
For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond T Chung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anticipate to share coded data with collaborators
IPD Sharing Time Frame
Anticipate data would be available to share within 6 months after the final patient completes the study.
IPD Sharing Access Criteria
Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.
Learn more about this trial
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
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