Back to resultsIg NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
Primary Purpose
Idiopathic Thrombocytopenic Purpura (ITP)
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
IgNextGen 10%
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura (ITP) focused on measuring ITP, IVIg, Platelet count, Bleeding
Eligibility 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: IVIg or anti-D immunoglobulin immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration 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.
Sites / Locations
- Canberra Hospital
- Royal Prince Alfred Hospital
- St George Hospital
- Princess Alexandra Hospital
- Redcliffe Hospital
- Royal Adelaide Hospital
- Monash Medical Centre
- Royal Perth Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
IVIg
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00362349
Brief Title
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
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 Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura (ITP)
Keywords
ITP, IVIg, Platelet count, Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
IVIg
Intervention Type
Drug
Intervention Name(s)
IgNextGen 10%
Intervention Description
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 Measure Information:
Title
Efficacy
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Safety
Time Frame
97 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
IVIg or anti-D immunoglobulin
immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beng N/A Chong, Professor
Organizational Affiliation
The St George Hospital (NSW, Australia)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canberra Hospital
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
St George Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Redcliffe Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
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