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

Phase 3

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura (ITP)
• Interventions: Drug: IgNextGen 10%

• Registration Number: NCT00362349
• Lead Sponsor: CSL Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-09
• Study First Submitted QC: 2006-08-09
• Study First Posted: 2006-08-10
• Study Start: 2007-06
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-02
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	IgNextGen 10%	IVIg

Primary Outcome Measures

Name	Time	Method
Efficacy	90 days

Secondary Outcome Measures

Name	Time	Method
Safety	97 days

Trial Locations

Locations (8)

Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

St George Hospital; 🇦🇺 Sydney, New South Wales, Australia

Canberra Hospital; 🇦🇺 Canberra, Australian Capital Territory, Australia

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia

Monash Medical Centre; 🇦🇺 Melbourne, Victoria, Australia

Redcliffe Hospital; 🇦🇺 Brisbane, Queensland, Australia