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Clinical Trials/NCT04508907
NCT04508907
Active, not recruiting
Phase 4

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

Mayo Clinic1 site in 1 country200 target enrollmentSeptember 10, 2020
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ConditionsHepatitis CKidney Transplant; ComplicationsHeart Transplant Infection
InterventionsMavyret
DrugsMavyret

Overview

Phase
Phase 4
Intervention
Mavyret
Conditions
Hepatitis C
Sponsor
Mayo Clinic
Enrollment
200
Locations
1
Primary Endpoint
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs
Status
Active, not recruiting
Last Updated
4 months ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2020
End Date
November 1, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bashar Aqel

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Arm 1: Pre-emptive Treatment Arm

Single arm study were all recipients of HCV viremic organs will receive combination therapy.

Intervention: Mavyret

Outcomes

Primary Outcomes

Rate of prevention of HCV viremia in recipients of HCV viremic solid organs

Time Frame: 3 months

The study will assess the percentage of patient who will not become HCV viremic using this preemptive treatment protocol.

Graft and patient survival

Time Frame: 1 year

Study will assess the overall 1 year patient and graft survival.

Study Sites (1)

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