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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000295
Receipt No. 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

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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
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Interventions/Control_6
Interventions/Control_7
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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
Email

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
Email

Sponsor
Institute Artificial Organ and Transplantation Division, Tokyo University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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