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Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant

NCT ID: NCT00242099

Last Updated: 2008-04-16

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-11-30

Brief Summary

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Human herpesvirus-6 (HHV-6) and -7 (HHV-7) infections are common after transplantation. Such infections may predispose transplant patients to other infections, contribute to a recurrence of hepatitis C virus, and affect rejection and function of the transplanted liver. Given the significant clinical impact of these viruses, routine laboratory monitoring may be beneficial by identifying patients who have persistent or high levels of infection. In these patients, immunosuppressive medications could be adjusted, or antiviral medications administered. There are currently no randomized trials that address this important question. This prospective, randomized trial will analyze whether routine laboratory monitoring for HHV-6 and -7 is clinically useful, and whether it would improve overall outcomes in transplant recipients.

Detailed Description

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Conditions

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Transplant

Keywords

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liver transplant HHV-6 HHV-7 Human Herpesvirus-6 Human Herpesvirus-7

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Monitoring - blood samples drawn to test for HHV-6 and HHV-7

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female patients who fulfill the following criteria are eligible for inclusion:

* Recipients of a liver transplant
* Able to give written informed consent
* Are willing and able to comply with the protocol
* Age \>= 18 years

Exclusion Criteria

The following patients are not eligible for inclusion in the study:

* Patients unwilling or unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Atul Humar, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Deepali Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Fernandez-Ruiz M, Kumar D, Husain S, Lilly L, Renner E, Mazzulli T, Moussa G, Humar A. Utility of a monitoring strategy for human herpesviruses 6 and 7 viremia after liver transplantation: a randomized clinical trial. Transplantation. 2015 Jan;99(1):106-13. doi: 10.1097/TP.0000000000000306.

Reference Type DERIVED
PMID: 25073037 (View on PubMed)

Other Identifiers

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PSI-04-53

Identifier Type: -

Identifier Source: secondary_id

04-0760-AE

Identifier Type: -

Identifier Source: org_study_id