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)

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.

Inclusion Criteria:

• clinical diagnosis of ITP
• platelet count of <50 X 10^9

Exclusion Criteria:

• planned splenectomy

• previous non-responders to IVIg treatment

• known or suspected hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy

• patients who have received treatment with:

  1. IVIg or anti-D immunoglobulin
  2. immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration
  3. patients who have received IV administration of steroids OR have had a change of oral corticosteroid treatment OR danazol within 15 days prior to first day of study drug administration.