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

Phase 4

Recruiting

• Conditions: Hepatitis C; Kidney Transplant; Complications; Heart Transplant Infection
• Interventions: Drug: Mavyret

• Registration Number: NCT04508907
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Study Start: 2020-09-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1: Pre-emptive Treatment Arm	Mavyret	Single arm study were all recipients of HCV viremic organs will receive combination therapy.

Primary Outcome Measures

Name	Time	Method
Rate of prevention of HCV viremia in recipients of HCV viremic solid organs	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	1 year	Study will assess the overall 1 year patient and graft survival.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States