A randomized non-inferiority trial of valganciclovir versus intravenous ganciclovir as preemptive therapy for cytomegalovirus infection in living donor liver transplantation.

UMIN ID: C000000295

Registered date:14/12/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: cytomegalovirus infection after living donor liver transplantation
• Date of first enrollment: 2005/12/01
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Participated patients will be divided into two groups randomaly. One is oral valganciclovir group and the other is intravenous ganciclovir group. Oral valganciclovir group is treated when patients have a positive cytomegalovirus pp65 antigenemia assasy. For initial treatment, administration of oral valganciclovir (900mg/body/12hr) is continued until one week after pp65 antigenemia assay turns negative. Then, for maintenance therpy, oral valganciclovir is administered (900mg/body/day) for one more week.
Intravenous ganciclovir group is treated when patients have a positive cytomegalovirus pp65 antigenemia assasy. For initial treatment, administration of intravenous ganciclovir (5.0mg/kg/12hr)is continued until one week after pp65 antigenemia assay turns negative. Then, for maintenance therapy, oral valganciclovir is administered (900mg/body/day) for one more week.

Outcome(s)

• Primary Outcome: 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: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Artificial Organ and Transplantation Division, Tokyo University Hospital
• Source(s) of Monetary Support: The Ministry of Education, Science, Sports and Culture