drugset / Trial / NCT00362349
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-06
- Primary completion
- 2008-10
- Completion
- 2008-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ig NextGen 10% | Protein / enzyme biologic | 0.4 g/kg | Intravenous |
| Subject | Ig NextGen 10% | Protein / enzyme biologic | 1 g/kg | Intravenous |