A randomized non-inferiority trial of valganciclovir versus intravenous ganciclovir as preemptive therapy for cytomegalovirus infection in living donor liver transplantation.
Not Applicable
- Conditions
- cytomegalovirus infection after living donor liver transplantation
- Registration Number
- JPRN-C000000295
- Lead Sponsor
- Artificial Organ and Transplantation Division, Tokyo University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients complicated with severe or uncontrollable diarrhea, or malabsorption. 2)Drug allergy to valganciclovir, ganciclovir or other other drugs(acyclovir, and valacyclovir) similar in structures with those two drugs. 3)Patients complicated with severe diseases including other infectious diseases. 4)Pregnat women or women of childbearing potential or brestfeeding 5)Patients who received a graft from ABO incopatible donor. 6)Patients for HIV infection 8)Patients who have symptoms due to cytomegalovirus infection at the onset of positive cytomegalovirus pp65 antigen assay. 9)Patients who are judged as inappropriate by a doctor in attendance for some medical reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is a status of cytomegalovirus pp65 antigenemia assay two weeks after the initiation of treatment. A positive antigenemia test is defined as the presence of more than 5 antigen-positive cells/50000 white blood cells.
- Secondary Outcome Measures
Name Time Method Secondary endpoint are the duration from the initiation of treatment to the acquirement of a negative antigenemia assay test, the rate of conversion to foscarnet, recurrence rate of cytomegalovirus infection during one month after the acquirement of a negative antigenemia assay test, the occurrence rate of rejection episodes to be treated during one year after transplantation, one year survival after transplantation, and the occurrence rate of cytomegalovirus disease.