cytomegalovirus infection after living donor liver transplantation
Conditions
Interventions
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 h
Sponsors
Artificial Organ and Transplantation Division, Tokyo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. living-donor liver transplantation recipient 2. Patients who are complicated with cytomegalovirus infection after liver transplantation for the first time. 3. Age >= 20 years 4. Patients who singned informed consent form to avoid pregnacy during the trial 5. Male patients who signed informed consent form to avoid pregnacy until 90 days after finishing the treatment. 6. Female patients who signed informed consent form to avoid breast feeding during the trial. 7. Patients who are relevant to the hematological data below. neutrophils>=1000 cells/microL platelet count>=50000 cells/microL hematocrit level>=18% 8. Estimated cleatinine clearance>=20 ml/minute estimated formula (Male)estimated cleatinine clearance (ml/minute) = (140-Age)x Body Weight(kg)/ (72xserum creatinine level (mg/dl)) (Female)estimated cleatinine clearance (ml/minute) =(140-Age)x0.86 x Body Weight(kg) /(72xserum creatinine level (mg/l) ) 9. Patients who is able to take oral medications
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYasuhiko Sugawara
Tokyo University Hospital Artificial Organ and Transplantation Division
Outcome results
None listed