Back to resultsDAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant
Primary Purpose
End Stage Liver Disease, Hepatitis C
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Treatment with Direct Acting Antiviral tablet
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Liver Disease focused on measuring HCV, Epclusa, ESLD
Eligibility Criteria
Inclusion Criteria:
- Recipient is Age ≥ 18 years
- Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
- HCV naïve
- Able to sign informed consent
Exclusion Criteria:
- Pregnant or nursing (lactating) women
- Human immunodeficiency virus (HIV) positivity
- Need for dual organ transplant
- Any contra-indication to liver transplantation per center protocol
Sites / Locations
- Masschusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination
Arm Description
12 weeks of HCV treatment with medically appropriate direct acting antiviral
Outcomes
Primary Outcome Measures
Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.
Secondary Outcome Measures
Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values
Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient.
Full Information
NCT ID
NCT03208127
First Posted
July 3, 2017
Last Updated
July 27, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03208127
Brief Title
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant
Official Title
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Liver Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Protocol transitioned to standard of care, no funding available to continue support of research work or data analysis
Study Start Date
November 21, 2017 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
June 4, 2021 (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 single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
Detailed Description
Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Liver Disease, Hepatitis C
Keywords
HCV, Epclusa, ESLD
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination
Arm Type
Experimental
Arm Description
12 weeks of HCV treatment with medically appropriate direct acting antiviral
Intervention Type
Drug
Intervention Name(s)
Treatment with Direct Acting Antiviral tablet
Other Intervention Name(s)
DAA
Intervention Description
HCV Treatment for 12 Weeks
Primary Outcome Measure Information:
Title
Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
Description
Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.
Time Frame
12 weeks post treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values
Description
Safety and tolerability of direct acting antiviral therapy in the liver transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating clinically significant out of range laboratory results as compared to baseline/pretreatment values per patient.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recipient is Age ≥ 18 years
Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
HCV naïve
Able to sign informed consent
Exclusion Criteria:
Pregnant or nursing (lactating) women
Human immunodeficiency virus (HIV) positivity
Need for dual organ transplant
Any contra-indication to liver transplantation per center protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Chung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masschusetts 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
Coded data is anticipated to be shared with potential collaborators.
IPD Sharing Time Frame
Anticipated that data from the study will become available within 6 months after the final patient completes the primary study endpoint (12 weeks post treatment)
IPD Sharing Access Criteria
Data would only be shared with Institutional Review Board (IRB) approved collaborators.
Learn more about this trial
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant
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