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

Idiopathic Thrombocytopenic Purpura (ITP) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362349
• Other study ID #: CSLCT-ITP-05-21
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2006
• Last updated: July 14, 2016
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: CSL Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura (ITP)
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• IgNextGen 10%
Ig NextGen 10% is a liquid formulation and is to be administered intravenously. At the discretion of the Investigator, patients could be administered Ig NextGen 10% in accordance with either of two dosage regimens: Regimen One: 1 g/kg body weight of Ig NextGen 10% administered daily for two days. Regimen Two: 0.4 g/kg body weight of Ig NextGen 10% administered daily for five days

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Redcliffe Hospital	Brisbane	Queensland
Australia	Canberra Hospital	Canberra	Australian Capital Territory
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	St George Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
CSL Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		90 days	No
Secondary	Safety		97 days	Yes