Overview

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

Status:
Unknown status

Trial end date:
2016-02-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Ain Shams University

Treatments:

Antibodies
gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin