Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | No Intervention | no platelet enhancing therapy | |
| group B | Active Comparator | Standard IVIG single dose 1.0 gm /kg/dose |
|
| group C | Experimental | minipool IVIG product single dose 1.0 gm /kg/dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG prepared by minipool technology | Drug | Drug: 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. |
| Measure | Description | Time Frame |
|---|---|---|
| bleeding score(SMOG) | change of bleeding score(SMOG) at day 3,week1,week 2 and week 4 after presentation | 4 weeks |
| complete blood count | 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | presence of side effects: anaphylaxis,fever,rash and any others | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mohsen elalfy, MD | Contact | elalfym@hotmail.com | ||
| marwa deghedy, MD | Contact | 01003355821 | marwareda24@yahoo.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt | Recruiting | Cairo | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| standard IVIG product | Drug | to compare efficacy and safety with the minipool IVIG |
|