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

This study has been completed.
Sponsor:
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00362349
First received: August 9, 2006
Last updated: February 5, 2009
Last verified: February 2009

August 9, 2006
February 5, 2009
June 2007
October 2008   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Efficacy
Complete list of historical versions of study NCT00362349 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 97 days ] [ Designated as safety issue: Yes ]
Safety
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Thrombocytopenic Purpura (ITP)
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

Experimental: 1
IVIg
Intervention: Drug: IgNextGen 10%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00362349
CSLCT-ITP-05-21
No
Dr Darryl Maher, CSLLimited
CSL Limited
Not Provided
Principal Investigator: Beng Chong, Professor The St George Hospital (NSW, Australia)
CSL Limited
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP