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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
History of Changes
  Purpose

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 Intervention Phase
Idiopathic Thrombocytopenic Purpura (ITP)
 Drug: IgNextGen 10%
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 97 days ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: June 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
IVIg
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362349

Locations
Australia, Australian Capital Territory
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
St George Hospital
Sydney, New South Wales, Australia, 2217
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
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
Investigators
Principal Investigator: Beng Chong, Professor The St George Hospital (NSW, Australia)
  More Information

No publications provided

Responsible Party: Dr Darryl Maher, CSLLimited
ClinicalTrials.gov Identifier: NCT00362349     History of Changes
Other Study ID Numbers: CSLCT-ITP-05-21
Study First Received: August 9, 2006
Last Updated: February 5, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by CSL Limited:
ITP
IVIg
Platelet count
Bleeding

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

ClinicalTrials.gov processed this record on June 18, 2013