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

NCT02669277 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-02-01

No results posted yet for this study

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.

Conditions

  • Newly Diagnosed Pediatric ITP

Interventions

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.

DRUG

standard IVIG product

to compare efficacy and safety with the minipool IVIG

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669277 on ClinicalTrials.gov