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Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor

Primary Purpose

Hepatitis C, Hepatitis C Virus Infection, Response to Therapy of

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
glecaprevir/pibrentasvir (GLE/PIB)
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis C

Eligibility Criteria

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

Inclusion Criteria:

  • adults aged 18 years or greater
  • participants actively listed for heart, lung and/or kidney transplant
  • participants have already consented to receive HCV-viremic organs as part of the institution's clinical practice protocol (involves education and informed consent), and are able to sign informed consent for this research study.

Exclusion Criteria:

  • participants who have a prior history of HCV infection regardless of treatment status, pre-existing human immunodeficiency virus (HIV) or hepatitis B virus (HBV) infection
  • participants who are not able to sign informed consent for this research study
  • participants who have not agreed to accept HCV+ organs as part of the UCSD clinical practice protocol
  • participants who are listed for a liver transplant (either as a single organ or combined organ transplant).

Sites / Locations

  • University of California San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

Outcomes

Primary Outcome Measures

Percentage of participants with Sustained Virological Response
The primary outcome is the percentage of patients sustained virological response (SVR) at day 91 after completion of a 7-day course of GLE/PIB.

Secondary Outcome Measures

Percentage of participants with treatment-related Serious Adverse Events
Safety and tolerability of the 7-day GLR/PIB course. Safety and tolerability will be assessed by documenting Serious Adverse Events (based on NIH criteria) for the duration of the study. Safety assessments will occur through review of the medical record of the patient, review of laboratory parameters and open-ended questions at the in-person assessments.

Full Information

First Posted
September 28, 2020
Last Updated
May 23, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04596475
Brief Title
Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor
Official Title
Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor to HCVNegative Organ Transplant Recipient - Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
April 21, 2022 (Actual)
Study Completion Date
April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This trial will be done in participants who undergo transplantation of heart, kidney or lung at University of California, San Diego (UCSD) and receive a hepatitis C infected donor organ. In this trial, the plan is to start hepatitis C treatment just before transplant surgery and treat for a short one-week course to see if hepatitis C infection can be prevented in the transplant recipient. The plan is to perform this trial in 10 participants and if successful, the next step is to try to make it standard of care as prevention of infection is better than treating hepatitis C after discharge from transplant surgery (which is usually a 12 week standard treatment).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hepatitis C Virus Infection, Response to Therapy of

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
glecaprevir/pibrentasvir (GLE/PIB)
Intervention Description
The study intervention consists of a single daily dose of GLE/PIB 100/40 mg (one dose consists of 3 tablets) administered orally; or crushed and administered via a feeding tube if participant is unable to swallow by mouth, for example in the immediate post-operative period. First dose will be administered in the pre-operative period within 4 hours of surgery followed by once daily doses for 7 days total.
Primary Outcome Measure Information:
Title
Percentage of participants with Sustained Virological Response
Description
The primary outcome is the percentage of patients sustained virological response (SVR) at day 91 after completion of a 7-day course of GLE/PIB.
Time Frame
91 days
Secondary Outcome Measure Information:
Title
Percentage of participants with treatment-related Serious Adverse Events
Description
Safety and tolerability of the 7-day GLR/PIB course. Safety and tolerability will be assessed by documenting Serious Adverse Events (based on NIH criteria) for the duration of the study. Safety assessments will occur through review of the medical record of the patient, review of laboratory parameters and open-ended questions at the in-person assessments.
Time Frame
91 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults aged 18 years or greater participants actively listed for heart, lung and/or kidney transplant participants have already consented to receive HCV-viremic organs as part of the institution's clinical practice protocol (involves education and informed consent), and are able to sign informed consent for this research study. Exclusion Criteria: participants who have a prior history of HCV infection regardless of treatment status, pre-existing human immunodeficiency virus (HIV) or hepatitis B virus (HBV) infection participants who are not able to sign informed consent for this research study participants who have not agreed to accept HCV+ organs as part of the UCSD clinical practice protocol participants who are listed for a liver transplant (either as a single organ or combined organ transplant).
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31521479
Citation
Aslam S, Yumul I, Mariski M, Pretorius V, Adler E. Outcomes of heart transplantation from hepatitis C virus-positive donors. J Heart Lung Transplant. 2019 Dec;38(12):1259-1267. doi: 10.1016/j.healun.2019.08.019. Epub 2019 Aug 24.
Results Reference
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PubMed Identifier
31353243
Citation
Bethea ED, Gaj K, Gustafson JL, Axtell A, Lebeis T, Schoenike M, Turvey K, Coglianese E, Thomas S, Newton-Cheh C, Ibrahim N, Carlson W, Ho JE, Shah R, Nayor M, Gift T, Shao S, Dugal A, Markmann J, Elias N, Yeh H, Andersson K, Pratt D, Bhan I, Safa K, Fishman J, Kotton C, Myoung P, Villavicencio MA, D'Alessandro D, Chung RT, Lewis GD. Pre-emptive pangenotypic direct acting antiviral therapy in donor HCV-positive to recipient HCV-negative heart transplantation: an open-label study. Lancet Gastroenterol Hepatol. 2019 Oct;4(10):771-780. doi: 10.1016/S2468-1253(19)30240-7. Epub 2019 Jul 26.
Results Reference
background
PubMed Identifier
30378723
Citation
Kwong AJ, Wall A, Melcher M, Wang U, Ahmed A, Subramanian A, Kwo PY. Liver transplantation for hepatitis C virus (HCV) non-viremic recipients with HCV viremic donors. Am J Transplant. 2019 May;19(5):1380-1387. doi: 10.1111/ajt.15162. Epub 2018 Nov 26.
Results Reference
background
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
background
PubMed Identifier
31652392
Citation
Gupta G, Yakubu I, Bhati CS, Zhang Y, Kang L, Patterson JA, Andrews-Joseph A, Alam A, Ferreira-Gonzalez A, Kumar D, Moinuddin IK, Kamal L, King AL, Levy M, Sharma A, Cotterell A, Reichman TW, Khan A, Kimball P, Stiltner R, Baldecchi M, Brigle N, Gehr T, Sterling RK. Ultra-short duration direct acting antiviral prophylaxis to prevent virus transmission from hepatitis C viremic donors to hepatitis C negative kidney transplant recipients. Am J Transplant. 2020 Mar;20(3):739-751. doi: 10.1111/ajt.15664. Epub 2019 Nov 15.
Results Reference
background
PubMed Identifier
32362393
Citation
Aslam S, Grossi P, Schlendorf KH, Holm AM, Woolley AE, Blumberg E, Mehra MR; working group members. Utilization of hepatitis C virus-infected organ donors in cardiothoracic transplantation: An ISHLT expert consensus statement. J Heart Lung Transplant. 2020 May;39(5):418-432. doi: 10.1016/j.healun.2020.03.004. Epub 2020 Mar 19.
Results Reference
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Prevention of Transmission of Hepatitis C Virus (HCV) From HCV-Viremic Organ Donor

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