Protocol summary
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Study aim
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1.The Effects of cyclosporine and Sirolimus on improving symptoms of patients with idiopathic thrombocytopenic purpura (ITP) will be compared.
2.The incidence of complications of cyclosporine and oral Sirolimus in patients with idiopathic thrombocytopenic purpura (ITP) will be compared.
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Design
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A clinical trial including two groups receiving oral cyclosporine and sirolimus, with parallel groups, single blind, randomized
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Settings and conduct
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this study is grounded in the field of idiopathic thrombocytopenic purpura in Arak city. After getting informed consent from the parents, demographic information will be recorded and patients will be divided into two groups receiving cyclosporine and Sirolimus(for 6 months) randomly.
The response rate in patients is an increase in platelet count, which is measured monthly.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria :
1.Children aged 5 to 15 years with chronic idiopathic thrombocytopenic purpura
2.Not having any other blood diseases
3.Parental informed consent
exclusion criteria :
1.Increase BUN / CR or decrease GFR by less than 50 ml / day.
2.Seizure
3.Allergic reaction
4.Oral drug intolerance
5.no response to drug treatment after 3 months.
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Intervention groups
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The control group received 5 mg / kg of cyclosporine twice a day
The Intervention group (received oral Sirolimus), on the first day, will received Sirolimus in loading dose 6 mg / m2/day(in children above 40 kg ) and 3mg/m2/day(children less than 40 kg). From the second day, children over 40 kg will receive 2 mg/m2 /day and under 40 kg will receive 1 mg/kg/day of Sirolimus.The control group consists of the same number of patients with the treatment groups which does not receive the two above drugs. Treatments will be received for 6 months.
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Main outcome variables
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Increase platelet count
General information
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Reason for update
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Given that the initial registration was not properly entered due to the importer's inexperience. The following require editing :
1. The sampling in the study was done after receiving IRCT code, but in the initial record, the sampling was entered before receiving the code, which was corrected.
2. This study is a randomized single blind study, but in the initial registration it has mistakenly recorded as a non-random and one blind study. This problem was corrected too.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180501039499N1
Registration date:
2018-08-12, 1397/05/21
Registration timing:
prospective
Last update:
2020-02-05, 1398/11/16
Update count:
1
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Registration date
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2018-08-12, 1397/05/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-10-17, 1397/07/25
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Expected recruitment end date
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2019-04-14, 1398/01/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison the efficacy and safety of Oral Sirolimus and oral cyclosporine in the chronic thrombocytopenic purpura immune in children
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Public title
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Comparison of the Effects of Oral Sirolimus and Oral Cyclosporine on the Thrombocytopenic Chronic Purpura
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Children aged 5 to 15 years with chronic idiopathic thrombocytopenic purpura
Not having any other blood diseases
Parental informed consent
Exclusion criteria:
Increase BUN / CR or decrease GFR by less than 50 ml / day.
Seizure
Allergic reaction
Oral drug intolerance
No response to drug treatment after 3 months.
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Age
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From 5 years old to 15 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization was done using permuted blocks of four different block sizes 2,4,6,8; then study subjects were separated 1:1 to Cyclosporine and sirolimos groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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After obtaining informed consent, patients will be randomly assigned to one of the two treatment groups(sirolimus or cyclosporine) and patients will be unaware of the type of treatment group they are in.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-07, 1397/04/16
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Ethics committee reference number
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IR.ARAKMU.REC.1397.064
Health conditions studied
1
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Description of health condition studied
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Idiopathic thrombocytopenic purpura
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ICD-10 code
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D69.3
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ICD-10 code description
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Immune thrombocytopenic purpura
Primary outcomes
1
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Description
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Idiopathic thrombocytopenic purpura
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Timepoint
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Platelet measurement at the beginning of the study, months 1 to 6 after treatment
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Method of measurement
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The number of platelets is measured by using the Cell counter sysmax device.
Intervention groups
1
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Description
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Control group: Patients in this group will receive oral cyclosporine 5 mg / kg / day twice a day for 6 months
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Receiving oral Sirolimus in this group is as follows, , the first day of the loading dose is 6 mg and from the second day, 2 mg per m2 of body weight per day (children over 40 kg) and or the first day of the loading dose is 3 mg and from the second day, 1 mg per m2 of body weight per day (children over 40 kg) for 6 months.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Informed consent
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When the data will become available and for how long
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2018/07/07
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To whom data/document is available
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It's free to the public
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Under which criteria data/document could be used
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It's free to the public
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From where data/document is obtainable
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Call
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What processes are involved for a request to access data/document
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48 hours after the call
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Comments
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48 hours after the call