Safety, Tolerability and Efficacy of Single Dose Low Cost Minipool Intravenous Immunoglobulins in Moderately Severe Newly Diagnosed ITP

NCT ID: NCT02669277

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-02-29

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.

Conditions

Newly Diagnosed Pediatric ITP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A

no platelet enhancing therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

group B

Standard IVIG single dose 1.0 gm /kg/dose

Group Type: ACTIVE_COMPARATOR

standard IVIG product

Intervention Type: DRUG

to compare efficacy and safety with the minipool IVIG

group C

minipool IVIG product single dose 1.0 gm /kg/dose

Group Type: EXPERIMENTAL

IVIG prepared by minipool technology

Intervention Type: 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.

Interventions

IVIG prepared by minipool technology

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.

Intervention Type: DRUG

standard IVIG product

to compare efficacy and safety with the minipool IVIG

Intervention Type: DRUG

Other Intervention Names

IG plasma

Eligibility Criteria

Inclusion Criteria

1. All newly diagnosed ITP patients (< 2 weeks from onset of the disease), with no platelet enhancing therapy.

2. Age eligible for study: 1-16 years old

3. Gender eligible for study: both sexes

4. Informed consent signed by patient or his legal guardian.

Exclusion Criteria

1. Patients started on steroid therapy.

2. Platelet count<10,000/mm3.

3. Having a life threatening bleeding.

4. Patients with known or suspected hypersensitivity to immunoglobulins or previous severe side effects to immunoglobulin therapy.

5. Treatment with immunosuppressive or other immunomodulatory drugs within 3 weeks prior to screening.

6. Treatment with any other investigational drug within 7 days before study entry.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohsen Saleh Elalfy

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mohsen elalfy, MD

Role: CONTACT

elalfym@hotmail.com

marwa deghedy, MD

Role: CONTACT

marwareda24@yahoo.com

01003355821

Facility Contacts

Mohsen Saleh Elalfy, professor

Role: primary

Other Identifiers

FMASU R30/2015

Identifier Type: -

Identifier Source: org_study_id