Ig NextGen 10% in ITP Patients

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.

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)

Conditions

Idiopathic Thrombocytopenic Purpura (ITP)

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Details

• Primary Outcome Measures: Efficacy
• Secondary Outcome Measures: Safety

Study Start

September 2006; Expected completion: December 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• clinical diagnosis of ITP
• platelet count of <50 X 10⁹

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:
  • IVIg or anti-D immunoglogulin
  • immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration
  • 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.

Total Enrolment

20

Contact Details

• Principal Investigator: Beng Chong, Professor +61 2 9350 2011, beng.chong@unsw.edu.au

Canberra Hospital, Canberra, Australian Capital Territory, 2605, Australia; Not yet recruiting

• Michael Pidcock, Dr +61 2 6244 2222

St George Hospital, Sydney, New South Wales, 2217, Australia; Not yet recruiting

• Beng Chong, Professor +61 2 9350 2011

Royal Prince Alfred Hospital, Sydney, New South Wales, 2050, Australia; Not yet recruiting

• John Gibson, Ass. Professor +61 2 9515 8031

Princess Alexandra Hospital, Brisbane, Queensland, 4102, Australia; Not yet recruiting

• Robert Bird, Dr +61 7 3240 2425

Redcliffe Hospital, Brisbane, Queensland, Australia; Recruiting

• Peter Wood, Dr p.wood@uq.net.au

Royal Adelaide Hospital, Adelaide, South Australia, Australia; Not yet recruiting

• John Lloyd, Ass. Professor

Monash Medical Centre, Melbourne, Victoria, 3168, Australia; Not yet recruiting

• Eng Gan, Assoc. Professor +61 3 9594 3477

Royal Perth Hospital, Perth, Western Australia, Australia; Not yet recruiting

• Ross Baker, Dr