UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000295 |
|---|---|
| Receipt number | R000000375 |
| Scientific Title | A randomized non-inferiority trial of valganciclovir versus intravenous ganciclovir as preemptive therapy for cytomegalovirus infection in living donor liver transplantation. |
| Date of disclosure of the study information | 2005/12/14 |
| Last modified on | 2010/06/13 09:37:54 |
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Basic information
Public title
A randomized non-inferiority trial of valganciclovir versus intravenous ganciclovir as preemptive therapy for cytomegalovirus infection in living donor liver transplantation.
Acronym
A randomized non-inferiority trial of valganciclovir versus intravenous ganciclovir for cytomegalovirus infection in living donor liver transplantation
Scientific Title
A randomized non-inferiority trial of valganciclovir versus intravenous ganciclovir as preemptive therapy for cytomegalovirus infection in living donor liver transplantation.
Scientific Title:Acronym
A randomized non-inferiority trial of valganciclovir versus intravenous ganciclovir for cytomegalovirus infection in living donor liver transplantation
Region
| Japan |
Condition
Condition
cytomegalovirus infection after living donor liver transplantation
Classification by specialty
| Infectious disease | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that treatment outcome for cytomegalovirus infection after living donor liver transplantation with oral valganciclovir is non-inferior to that of intravenous ganciclovir.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
Interventions/Control_2
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Sugawara |
Organization
Tokyo University Hospital
Division name
Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Sugawara |
Organization
Tokyo University Hospital
Division name
Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
Artificial Organ and Transplantation Division, Tokyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Science, Sports and Culture
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 12 | Month | 13 | Day |
Last modified on
| 2010 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000375
