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

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Completed
Phase 4

Conditions

Transplant

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00242099
04-0760-AE
PSI-04-53

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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