NCT00362349

Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients

A Single-arm, Open Label, Multi-centre Study Evaluating the Efficacy and Safety of Ig NexGen 10% in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: CSL Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by isolated low platelet counts. The aim of treating patients with ITP is to increase the platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy and safety of Ig NextGen 10% in adult patients with ITP.

Conditions

• Idiopathic Thrombocytopenic Purpura (ITP)

Interventions

Type	Name	Description
DRUG	IgNextGen 10%	Ig NextGen 10% is a liquid formulation and is to be administered intravenously. At the discretion of the Investigator, patients could be administered Ig NextGen 10% in accordance with either of two dosage regimens: Regimen One: 1 g/kg body weight of Ig NextGen 10% administered daily for two days. Regimen Two: 0.4 g/kg body weight of Ig NextGen 10% administered daily for five days

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-08-10
• Last updated: 2016-07-18

Locations

8 sites across 1 country: Australia