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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362349
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : July 18, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura (ITP) Drug: IgNextGen 10% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : June 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 97 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362349

Australia, Australian Capital Territory
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
St George Hospital
Sydney, New South Wales, Australia, 2217
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Redcliffe Hospital
Brisbane, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Sponsors and Collaborators
CSL Limited
Principal Investigator: Beng N/A Chong, Professor The St George Hospital (NSW, Australia)

Responsible Party: CSL Limited Identifier: NCT00362349     History of Changes
Other Study ID Numbers: CSLCT-ITP-05-21
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: February 2009

Keywords provided by CSL Limited:
Platelet count

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases