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

Transplant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242099
• Other study ID #: 04-0760-AE
• Secondary ID: PSI-04-53
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2005
• Last updated: April 15, 2008
• Start date: February 2005
• Est. completion date: November 2007

Study information

• Verified date: February 2005
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Transplant

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse clinic events due to direct or indirect effects.