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

NCT ID: NCT04508907

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C Kidney Transplant; Complications Heart Transplant Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Pre-emptive Treatment Arm

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

Group Type EXPERIMENTAL

Mavyret

Intervention Type DRUG

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

Interventions

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Mavyret

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

Intervention Type DRUG

Other Intervention Names

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Zetia

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Bashar Aqel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bashar A Aqel

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Phoenix, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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20-001964

Identifier Type: -

Identifier Source: org_study_id