Back to resultsA Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients
Primary Purpose
Hepatitis C, Kidney Transplant; Complications, Heart Transplant Infection
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mavyret
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
Inclusion criteria:
- Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection
- Willing to accept and consent for accepting hepatitis C positive graft
Exclusion criteria:
- Existing chronic liver disease (liver cirrhosis)
- Concomitant infection with HIV or Chronic hepatitis B
- Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
- Pregnancy (Pregnant patients do not undergo solid organ transplants)
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: Pre-emptive Treatment Arm
Arm Description
Single arm study were all recipients of HCV viremic organs will receive combination therapy.
Outcomes
Primary Outcome Measures
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs
The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.
Graft and patient survival
Study will assess the overall 1 year patient and graft survival.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04508907
Brief Title
A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients
Official Title
Pilot Study for the Use of Shortened Preemptive Therapy With Glecaprevir/Pibrentasvir (G/P) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is being done to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Kidney Transplant; Complications, Heart Transplant Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Pre-emptive Treatment Arm
Arm Type
Experimental
Arm Description
Single arm study were all recipients of HCV viremic organs will receive combination therapy.
Intervention Type
Drug
Intervention Name(s)
Mavyret
Other Intervention Name(s)
Zetia
Intervention Description
Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients
Primary Outcome Measure Information:
Title
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs
Description
The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.
Time Frame
3 months
Title
Graft and patient survival
Description
Study will assess the overall 1 year patient and graft survival.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Listed kidney, heart, lung and/or pancreas patients who are negative for chronic hepatitis C infection
Willing to accept and consent for accepting hepatitis C positive graft
Exclusion criteria:
Existing chronic liver disease (liver cirrhosis)
Concomitant infection with HIV or Chronic hepatitis B
Patient or any member of patient family or care giver team who does not understand or accept the risk of an acquired HCV infection
Pregnancy (Pregnant patients do not undergo solid organ transplants)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bashar A Aqel
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients
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