1 . Objectives: Gansiklovir prophylaxis in the prevention of post- transplant lymphoproliferative disease , ¬ 2. Design of non- blind , single- center , phase 3 clinical trial 3. Participants in the study inclusion criteria : age less than 18 years ;performing a liver transplant exclusion criteria : transplant before July 88 and after March 90; die within the first week after transplantation due to postoperative complications 4 . the sample size : 203 patients 5. way to intervention group children who underwent liver transplantation were enrolled and received prophylaxis Gansyklvvyr . Control group of children who had undergone liver transplantation but did not receive Gansiclovir 6. Intervention : a month 7 . Changing the primary outcome : prevention of lymphoproliferative disorders
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120215530N2
Registration date:2014-01-31, 1392/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-31, 1392/11/11
Registrant information
Name
Karamali Kasiri
Name of organization / entity
Shahrekord University of Medical sciences.
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
kasiri@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences.
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of ganciclovir in the prevention of Post-transplant lymph proliferative disease in children underwent liver transplantation
Public title
role of ganciclovir in the prevention of Post-transplant lymph proliferative disease in children underwent liver transplantation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age less than 18 years; performing a liver transplant
Exclusion criteria: transplant before July 88 and after March 90; die within the first week after transplantation due to postoperative complications
Age
To 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
203
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Shiraz Medical university of sciences
Street address
Shiraz Medical university of sciences
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
59-30-90
Health conditions studied
1
Description of health condition studied
Transplanted organ and tissue status
ICD-10 code
Z94.4
ICD-10 code description
Liver transplant status
Primary outcomes
1
Description
prevention of Post-transplant lymph proliferative disease
Timepoint
A month later
Method of measurement
examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: children who underwent a liver transplant in January 2010 to the end of 2011 received prophylaxis Gansiclovir10mg/kg,Two divided doses.
Category
Treatment - Drugs
2
Description
Control group:children who had undergone liver transplantation but did not receive Gansiklovir.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital Shiraz
Full name of responsible person
Karamali Kasiri
Street address
Shiraz،Zand Street ،the prayer Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research,Shiraz University of Medical Sciences
Full name of responsible person
Vice Chancellor for research,Shiraz University of Medical l Sciences
Street address
Vice Chancellor for research,Shiraz University of Medical ,Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research,Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahrekord University of Medica Sciences.
Full name of responsible person
karamali kasiri
Position
Pediatric gastroenterologist.
Other areas of specialty/work
Street address
Rahmatie,Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
kasiri@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
ShahrekordUniversity of Medical Sciences.
Full name of responsible person
Karamali Kasiri
Position
Pediatric gastroenterologist,Assistant Professor
Other areas of specialty/work
Street address
Rahmatie,Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5652
Fax
Email
kasiri@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences.
Full name of responsible person
Karamali Kasiri
Position
Pediatric gastroenterologist,Assistant Professor
Other areas of specialty/work
Street address
Rahmatie, ShahrekordUniversity of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1222 0016
Fax
Email
kasiri@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)