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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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History
# Registration date Revision Id
2 2020-02-04, 1398/11/15 120785
1 2018-08-12, 1397/05/21 56128
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  • Protocol summary

    A clinical trial including two groups receiving oral cyclosporine and sirolimus, with parallel groups, one blind, non-random
    A clinical trial including two groups receiving oral cyclosporine and sirolimus, with parallel groups, single blind, randomized
    کارآزمایی بالینی شامل دو گروه دریافت کننده سیکلوسپورین و سیرولیموس خوراکی، با گروههای موازی، یک سویه کور، غیر تصادفی
    کارآزمایی بالینی شامل دو گروه دریافت کننده سیکلوسپورین و سیرولیموس خوراکی، با گروههای موازی، یک سویه کور، تصادفی
    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)non randomly. The response rate in patients is an increase in platelet count, which is measured monthly.
    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.
    این مطالعه در زمینه بیماری ایدیوپاتیک ترومبوسایتوپنیک پورپورا، در شهر اراک انجام می شود. پس از کسب رضایت آگاهانه از والدین بیماران، اطلاعات دموگرافیک بیماران ثبت و بیماران به صورت غیر صادفی به دو گروه دریافت کننده سیکلوسپورین و سیرولیموس (به مدت 6 ماه) تقسیم خواهند شد. معیار پاسخ درمان در بیماران افزایش در تعداد پلاکت است که بصورت ماهانه اندازه گیری می شود.
    این مطالعه در زمینه بیماری ایدیوپاتیک ترومبوسایتوپنیک پورپورا، در شهر اراک انجام می شود. پس از کسب رضایت آگاهانه از والدین بیماران، اطلاعات دموگرافیک بیماران ثبت و بیماران به صورت تصادفی به دو گروه دریافت کننده سیکلوسپورین و سیرولیموس (به مدت 6 ماه) تقسیم خواهند شد. معیار پاسخ درمان در بیماران افزایش در تعداد پلاکت است که بصورت ماهانه اندازه گیری می شود.

  • General information

    Not randomized
    Randomized
    2018-07-07, 1397/04/16
    2018-10-17, 1397/07/25
    2019-07-07, 1398/04/16
    2019-04-14, 1398/01/25
    empty
    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.
    empty
    با توجه به اینکه ثبت اولیه به علت بی تجرگی وارد کننده در قسمتهای زیر به صورت صحیح وارد نشده بود اصلاح موارد اعمال شده و ارسال شد: 1.نمونه گیری در مطالعه ی انجام شده پس از اخد کد IRCT صورت گرفته است اما در ثبت اولیه، نمونه گیری قبل از دریافت کد وارد شده بود که اصلاح شد. 2.مطالعه ی انجام شده به صورت یک سویه کور و تصادفی بوده که در ثبت اولیه به اشتباه غیر تصادفی و یک سویه کور ثبت شده بود که این مورد نیز اصلاح شد.
    کودکان 5 تا 15 سال مبتلا بهن ترومبوسایتوپیک پورپورای اتوایمن مزمن
    عدم ابتلا به سایر بیماری های خونی
    رضایت آگاهانه والدین
    کودکان 5 تا 15 سال مبتلا به ترومبوسایتوپیک پورپورای اتوایمن مزمن
    عدم ابتلا به سایر بیماری های خونی
    رضایت آگاهانه والدین
    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.
    تصادفی سازی با استفاده از بلوک در سایزهای 2مختلف 2، 4، 6 انجام شد. سپس افراد مورد مطالعه به صورت 1:1 در گروههای دریفات کننده سیرولیموس و سیکلوسپورین قرار گرفت.

Protocol summary

Study aim
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.
Design
A clinical trial including two groups receiving oral cyclosporine and sirolimus, with parallel groups, single blind, randomized
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Increase platelet count

General information

Reason for update
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.
Acronym
IRCT registration information
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
Registration date
2018-08-12, 1397/05/21
Registrant information
Name
Morteza Mousavihasanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 0099
Email address
m.mousavihasanzadeh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-17, 1397/07/25
Expected recruitment end date
2019-04-14, 1398/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy and safety of Oral Sirolimus and oral cyclosporine in the chronic thrombocytopenic purpura immune in children
Public title
Comparison of the Effects of Oral Sirolimus and Oral Cyclosporine on the Thrombocytopenic Chronic Purpura
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
ََAmir kabir hospital, Khoram AVe, Arak Town
City
Arak
Province
Markazi
Postal code
38146-7-5999
Approval date
2018-07-07, 1397/04/16
Ethics committee reference number
IR.ARAKMU.REC.1397.064

Health conditions studied

1

Description of health condition studied
Idiopathic thrombocytopenic purpura
ICD-10 code
D69.3
ICD-10 code description
Immune thrombocytopenic purpura

Primary outcomes

1

Description
Idiopathic thrombocytopenic purpura
Timepoint
Platelet measurement at the beginning of the study, months 1 to 6 after treatment
Method of measurement
The number of platelets is measured by using the Cell counter sysmax device.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Patients in this group will receive oral cyclosporine 5 mg / kg / day twice a day for 6 months
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir kabir Hospital
Full name of responsible person
Morteza.mousavihasanzadeh
Street address
َAmir kabir Hospital, Khoram AVe, Arak town
City
Arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
Morteza.mousavi1993@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Morteza.MousaviHasanzadeh
Street address
Amir kabir Hospital, Khoram Ave
City
Arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
Morteza.mousavi1993@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Morteza MousaviHasanzadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Khoram street
City
Arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
Morteza.mousavi1993@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
aziz eghbali
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Khoram AVe
City
Arak
Province
Markazi
Postal code
38146-7-5999
Phone
+98 86 3322 0099
Email
aziz_eghbali@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Morteza MousaviHasanzadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Pediatrics
Street address
Amirkabir Hospital, Khoram Ave
City
Arak
Province
Markazi
Postal code
38146-7-5999
Phone
+95 8633220099
Email
Morteza.mousavi1993@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Informed consent
When the data will become available and for how long
2018/07/07
To whom data/document is available
It's free to the public
Under which criteria data/document could be used
It's free to the public
From where data/document is obtainable
Call
What processes are involved for a request to access data/document
48 hours after the call
Comments
48 hours after the call
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