Status:
COMPLETED
Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
Lead Sponsor:
CSL Limited
Conditions:
Idiopathic Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 concentrat...
Eligibility Criteria
Inclusion
- clinical diagnosis of ITP
- platelet count of \<50 X 10\^9
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00362349
Start Date
June 1 2007
End Date
October 1 2008
Last Update
July 18 2016
Active Locations (8)
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1
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
2
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
3
St George Hospital
Sydney, New South Wales, Australia, 2217
4
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102