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Transplanting Hepatitis C Positive Organs

Primary Purpose

Hepatitis C, Awaiting Organ Transplant

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sofosbuvir/velpatasvir
Monitoring
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women who are age ≥ 18 years
  • Active on either the cardiac, lung, or kidney transplant waiting list
  • Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection

Exclusion Criteria:

  • Hepatitis B NAT or viral load positive
  • Evidence of cirrhosis or clinically significant liver disease

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HCV NAT Positive Donor

HCV NAT Negative, HCV Ab Positive Donor

Arm Description

Intervention: 2 week treatment course with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily Participants who receive allografts from a donor who is HCV NAT positive will receive treatment with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily, beginning on the day of transplant.

Intervention: HCV viral load monitoring Participants who receive allografts from a donor who is HCV Ab positive and NAT negative will have close serial HCV viral load monitoring and will be treated with a direct acting antiviral, 400mg / velpatasvir 100mg daily, for 6 weeks if HCV viremia develops.

Outcomes

Primary Outcome Measures

Graft survival
Functioning allograft not requiring mechanical support
HCV status of the transplant recipient
Sustained virologic response (SVR) 12 weeks after HCV treatment completion in Arm A or at 6 months in Arm B (SVR defined as HCV RNA < lower limit of quantification)

Secondary Outcome Measures

Treatment related adverse events
Number of treatment related adverse events per patient using direct-acting antiviral HCV regimens in post transplant recipients

Full Information

First Posted
September 12, 2016
Last Updated
October 10, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03086044
Brief Title
Transplanting Hepatitis C Positive Organs
Official Title
Transplanting Organs From Hepatitis C Positive Donors to Hepatitis C Uninfected Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's 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
Yes

5. Study Description

Brief Summary
This is an open-label, pilot safety and efficacy trial for adults who are active on the heart, lung, or kidney transplantation lists and are eligible to receive an organ from an increased risk donor who has evidence of active or prior hepatitis C infection (HCV).
Detailed Description
This is an open label pilot study transplanting organs from Hepatitis C positive donors into HCV uninfected recipients at Brigham and Women's Hospital. Heart, lung and kidney transplant participants will be stratified into two different study arms depending on whether the donor of the organ was HCV nucleic acid amplifications technology (NAT) positive or negative. In the NAT positive arm, the recipients will receive a course of direct acting antivirals (DAA) to begin on the day of transplant. If the donor was HCV antibody (Ab) positive and NAT negative, the recipients will receive close monitoring with serial HCV viral loads (VL) and will only begin treatment with DAA if they develop HCV viremia.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HCV NAT Positive Donor
Arm Type
Experimental
Arm Description
Intervention: 2 week treatment course with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily Participants who receive allografts from a donor who is HCV NAT positive will receive treatment with a direct acting antiviral, sofosbuvir 400mg / velpatasvir 100mg daily, beginning on the day of transplant.
Arm Title
HCV NAT Negative, HCV Ab Positive Donor
Arm Type
Experimental
Arm Description
Intervention: HCV viral load monitoring Participants who receive allografts from a donor who is HCV Ab positive and NAT negative will have close serial HCV viral load monitoring and will be treated with a direct acting antiviral, 400mg / velpatasvir 100mg daily, for 6 weeks if HCV viremia develops.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir/velpatasvir
Other Intervention Name(s)
Epclusa
Intervention Description
2 weeks of treatment beginning on the day of transplant
Intervention Type
Other
Intervention Name(s)
Monitoring
Other Intervention Name(s)
Sofosbuvir/velpatasvir (Epclusa)
Intervention Description
Close HCV viral load monitoring Will receive direct acting antiviral treatment with 6 weeks of sofosbuvir/velpatasvir if the recipient develops HCV viremia during the post-transplant HCV viral load testing
Primary Outcome Measure Information:
Title
Graft survival
Description
Functioning allograft not requiring mechanical support
Time Frame
6 months post-transplant
Title
HCV status of the transplant recipient
Description
Sustained virologic response (SVR) 12 weeks after HCV treatment completion in Arm A or at 6 months in Arm B (SVR defined as HCV RNA < lower limit of quantification)
Time Frame
6 months post-transplant
Secondary Outcome Measure Information:
Title
Treatment related adverse events
Description
Number of treatment related adverse events per patient using direct-acting antiviral HCV regimens in post transplant recipients
Time Frame
6 months post-transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women who are age ≥ 18 years Active on either the cardiac, lung, or kidney transplant waiting list Willing and able to provide written informed consent to receive organs from an increased risk donor with a known transmissible infection Exclusion Criteria: Hepatitis B NAT or viral load positive Evidence of cirrhosis or clinically significant liver disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Woolley, MD
Phone
617-732-5500
Email
awoolley@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Baden, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Woolley, MD
Phone
617-525-8418
Email
awoolley@partners.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30946553
Citation
Woolley AE, Singh SK, Goldberg HJ, Mallidi HR, Givertz MM, Mehra MR, Coppolino A, Kusztos AE, Johnson ME, Chen K, Haddad EA, Fanikos J, Harrington DP, Camp PC, Baden LR; DONATE HCV Trial Team. Heart and Lung Transplants from HCV-Infected Donors to Uninfected Recipients. N Engl J Med. 2019 Apr 25;380(17):1606-1617. doi: 10.1056/NEJMoa1812406. Epub 2019 Apr 3.
Results Reference
derived

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Transplanting Hepatitis C Positive Organs

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