Newly Diagnosed Pediatric ITP Clinical Trial
Official title:
Safety, Tolerability and Efficacy of Single Dose Low Cost Minipool Intravenous Immunoglobulins in Moderately Severe Newly Diagnosed ITP: A Prospective Randomized Study
To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed
by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.
The platelet response rate is defined as the percentage of subjects responding to treatment
with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 100 x 10^9/L and absence of
bleeding (complete response) or platelet count ≥ 50 x 10^9/L and at least 2-fold increase
the base line count with absence of bleeding (partial response), within the specified time
frame.
To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed
by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.
The platelet response rate is defined as the percentage of subjects responding to treatment
with an increase of platelet count from ≤ 20 x 10^9/L to ≥ 100 x 10^9/L and absence of
bleeding (complete response) or platelet count ≥ 50 x 10^9/L and at least 2-fold increase
the base line count with absence of bleeding (partial response), within the specified time
frame.
Secondary:
1. To assess safety of mini-pool IVIG in patients with newly diagnosed ITP by assessing
frequency of adverse events related to mini-pool IgG administration
2. To compare data on efficacy and safety of mini-pool IVIG with data obtained from
literature on standard IVIG.
Study population:
Patients with newly diagnosed ITP attending Hematology clinic Ain Shams Children hospital
Sample size:
Seventy- two patients will be enrolled. They will be divided into 3 groups:
Group A; platelet non enhancing group Group B; group receiving standard IVIG Group C; group
receiving IVIG New product 24 patients in each group in a ratio 1:1:1.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment