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OpenTrials
Completed

NCT Number: NCT00242099

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

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.

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Key information

Conditions

Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Health Network

Toronto, Ontario, M5G2N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Primary outcomes

  1. Adverse clinic events due to direct or indirect effects.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

The Clinical Utility of Monitoring for Human Herpesvirus-6 (HHV-6) and Human Herpesvirus-7 (HHV-7) After Liver Transplant: A Randomized Trial

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 19, 2005
Registry last updated
Apr 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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