Safety, Tolerability and Efficacy of Single Dose Low Cost Minipool Intravenous Immunoglobulins in Moderately Severe Newly Diagnosed ITP
- Conditions
- Newly Diagnosed Pediatric ITP
- Interventions
- Drug: standard IVIG productDrug: IVIG prepared by minipool technology
- Registration Number
- NCT02669277
- Lead Sponsor
- Ain Shams University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- All newly diagnosed ITP patients (< 2 weeks from onset of the disease), with no platelet enhancing therapy.
- Age eligible for study: 1-16 years old
- Gender eligible for study: both sexes
- Informed consent signed by patient or his legal guardian.
- Patients started on steroid therapy.
- Platelet count<10,000/mm3.
- Having a life threatening bleeding.
- Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy.
- Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening.
- Treatment with any other investigational drug within 7 days before study entry.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group B standard IVIG product Standard IVIG single dose 1.0 gm /kg/dose group C IVIG prepared by minipool technology minipool IVIG product single dose 1.0 gm /kg/dose
- Primary Outcome Measures
Name Time Method bleeding score(SMOG) 4 weeks change of bleeding score(SMOG) at day 3,week1,week 2 and week 4 after presentation
complete blood count 4 weeks change of complete blood count for number of platelets,absolute neutrophil count,absolute lymphocyte count and hemoglobin at day 3,week 1,week 2 and week 4 after presentation
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events 4 weeks presence of side effects: anaphylaxis,fever,rash and any others
Trial Locations
- Locations (1)
hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt
🇪🇬Cairo, Egypt