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

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00242099
First received: October 18, 2005
Last updated: April 15, 2008
Last verified: February 2005
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00242099     History of Changes
Other Study ID Numbers: 04-0760-AE, PSI-04-53
Study First Received: October 18, 2005
Last Updated: April 15, 2008
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 September 16, 2014