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Sponsors and Collaborators: |
University Health Network, Toronto The Physicians' Services Incorporated Foundation |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00242099 |
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 |
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Transplant |
Procedure: Monitoring - blood samples drawn to test for HHV-6 and HHV-7 |
Phase IV |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female patients who fulfill the following criteria are eligible for inclusion:
Exclusion Criteria:
The following patients are not eligible for inclusion in the study:
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G2N2 |
Principal Investigator: | Atul Humar, MD | University Health Network, Toronto |
Principal Investigator: | Deepali Kumar, MD | University Health Network, Toronto |
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 |
liver transplant HHV-6 HHV-7 Human Herpesvirus-6 Human Herpesvirus-7 |