Status:
COMPLETED
The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP.
Lead Sponsor:
Nayera Hazaa Elsherif
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
Using eltronmobag as an alternative pathway, which depend on stimulation of thrombocyte synthesis, in chronic and persistent immune thrombocytopenia may be more promising treatment than the classic ty...
Detailed Description
Primary immune thrombocytopenia (ITP) is an acquired immune-mediated disorder characterized by isolated thrombocytopenia, defined as a peripheral blood platelet count less than 100 ×109/l and the abse...
Eligibility Criteria
Inclusion
- Age ≥ 1 to ≤ 18 years at enrollment. Patient should be able to swallow tablet form. Weight should be ≥ 12kg.
- Diagnosis of persistent (3-\<12 months duration) or chronic cases (≥12 months duration) with day 1 platelet count ≤ 20x10\^9.
- Patients have a bleeding score grade 3 for skin and/or grade 2 or higher for mucosal domains and/or higher than grade 1 for organ domain at the baseline visit or the worst bleeding incident episode in the patient's medical reports in the last 3 months prior screening, using ITP-BAT (v1.0) score.
- Normal Kidney function tests and liver function tests.
Exclusion
- Acute thrombocytopenic purpura patients or Other causes of thrombocytopenia. Patients with Evans syndrome
- Hypertension, cardiovascular disease, diabetes, hepatitis C virus (HCV), HIV, hepatitis B surface antigen(HBsAg) seropositive status.
- Baseline bone marrow biopsy with evident fibrosis (reticulin stain grade 2 or more)
- Patients who have previously received eltrombopag.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03412188
Start Date
August 1 2018
End Date
September 1 2021
Last Update
October 28 2021
Active Locations (1)
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1
Ainshams University , Faculty of medicine , Pediatric Hematology&Oncology unit, children hospital.
Cairo, Egypt, 11579