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

CSL Limited

Status and phase

Completed

Phase 3

Conditions

Idiopathic Thrombocytopenic Purpura (ITP)

Treatments

Drug: IgNextGen 10%

Study type

Interventional

Funder types

Industry

Identifiers

NCT00362349

CSLCT-ITP-05-21

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.