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NCT04508907 Clinical Trial

A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04508907
Other study ID # 20-001964
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 10, 2020
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Mayo Clinic
Contact Bashar Aqel
Phone 4803420272
Email aqel.bashar@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mavyret
Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients

Locations
Country Name City State
United States Mayo Clinic in Arizona Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 3 months
Primary Graft and patient survival Study will assess the overall 1 year patient and graft survival. 1 year
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