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

This study has been completed.

First Received: October 18, 2005 Last Updated: April 15, 2008 History of Changes

Sponsors and Collaborators:	University Health Network, Toronto The Physicians' Services Incorporated Foundation
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00242099

Purpose

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.

Condition	Intervention	Phase
Transplant	Procedure: Monitoring - blood samples drawn to test for HHV-6 and HHV-7	Phase IV

MedlinePlus related topics: Liver Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	The Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant: A Randomized Trial

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Adverse clinic events due to direct or indirect effects.

Estimated Enrollment:	160
Study Start Date:	February 2005
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242099

Locations

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G2N2

Sponsors and Collaborators

University Health Network, Toronto

The Physicians' Services Incorporated Foundation

Investigators

Principal Investigator:	Atul Humar, MD	University Health Network, Toronto
Principal Investigator:	Deepali Kumar, MD	University Health Network, Toronto

More Information

No publications provided

Study ID Numbers:	04-0760-AE, PSI-04-53
Study First Received:	October 18, 2005
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00242099 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

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

ClinicalTrials.gov processed this record on May 07, 2009