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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02669277
• Other study ID #: FMASU R30/2015
• Status: Recruiting
• Phase: Phase 2
• First received: January 20, 2016
• Last updated: January 27, 2016
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2016
• Source: Ain Shams University
• Contact: mohsen elalfy, MD
• Email: elalfym[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Newly Diagnosed Pediatric ITP

Intervention

Drug:
• 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.
• standard IVIG product
to compare efficacy and safety with the minipool IVIG

Locations

Country	Name	City	State
Egypt	hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bleeding score(SMOG)	change of bleeding score(SMOG) at day 3,week1,week 2 and week 4 after presentation	4 weeks	No
Primary	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	No
Secondary	Number of participants with treatment-related adverse events	presence of side effects: anaphylaxis,fever,rash and any others	4 weeks	Yes