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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00362349
Study type Interventional
Source CSL Limited
Contact
Status Completed
Phase Phase 3
Start date June 2007
Completion date October 2008

See also
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Completed NCT00860600 - Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) Patients Phase 2
Completed NCT01713738 - Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Phase 1/Phase 2
Withdrawn NCT00161564 - A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone Phase 2
Terminated NCT00571467 - Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP Phase 1