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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: CSL Limited

Current Primary Outcome: Efficacy [ Time Frame: 90 days ]

Original Primary Outcome: Efficacy

Current Secondary Outcome: Safety [ Time Frame: 97 days ]

Original Secondary Outcome: Safety

Information By: CSL Limited

Dates:
Date Received: August 9, 2006
Date Started: June 2007
Date Completion:
Last Updated: July 14, 2016
Last Verified: February 2009