Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202403843973020 Date of Approval: 27/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title High Dose Dexamethasone versus Prednisone as First Line Therapy in Newly diagnosed Immune Thrombocytopenic Purpura in Children
Official scientific title High Dose Dexamethasone versus Prednisone as First Line Therapy in Newly diagnosed Immune Thrombocytopenic Purpura in Children
Brief summary describing the background and objectives of the trial Immune thrombocytopenic purpura (ITP) is an autoimmune disease with antibodies detectable against several platelet surface antigens. Prednisone is considered as first line therapy for pediatric ITP but it has adverse effects. In addition, prolonged drug exposure can cause reduced growth . Compared to prednisone , high-dose dexamethasone (HDD) is considered the first-line treatment for previously untreated ITP in adults , and a second-line treatment in children ITP as recommended from American Society of Hematology 2011 Guidelines (for Pediatric Patients ) ; HDD has been associated with less adverse effects compared with standard prednisone.The aim of this study is to compare the efficacy of high dose dexamethasone and prednisone as a first line therapy for newly diagnosed immune thrombocytopenic purpura in children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2023
Actual trial start date 02/09/2023
Anticipated date of last follow up 01/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group prednisone 2 mg/kg/day for 1 week conventional treatment (first line) 30 Active-Treatment of Control Group
Experimental Group dexamethasone 0.6 mg/kg/day for 4 days Patients who did reach a response after 2 weeks will receive a second cycle of dexamethasone second line treatment in children 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children aged 1–18 years with newly diagnosed primary ITP before starting any treatment having platelet count < 30,000 /µL 1-Patients with secondary ITP including leukemia, drugs, lupus erythematous, hepatitis C, anti-phospholipid syndrome. 2-Ptaients with ITP who received any treatment. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 12 Month(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/11/2022 Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome an early response, initial response, and durable response and remission rates in both groups. 1 week , 1 month , 3 months after treatment
Secondary Outcome bleeding score and glucocorticoid-related side effects 1 week , 1 month , 3 months after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine of tanta university El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman Mohammed Elaskary El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
Ali Elbaghdady Nagy El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
Adel Abd El Haleim Hagag El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
Rasha Adel Elkholy El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Elaskary eman_elaskary@yahoo.com +201003007638 El-Gharbia Govenorate,Tanta . El-Gash st.
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Pediatrics
Role Name Email Phone Street address
Public Enquiries Adel Abd El Haleim Hagag adelhagag20@yahoo.com +201005020768 El-Gharbia Govenorate,Tanta . El-Gash st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Adel Hagag adelhagag20@yahoo.com +201005020768 El-Gharbia Govenorate,Tanta . El-Gash st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of Pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share de-identified individual trial participant data . All of the individual participant data collected during the trial and after de identification will be available for anyone who whishes to access the data for any purpose. Statistical Analysis Plan,Study Protocol after completion of research and publication of the paper on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information