Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
Information source: CSL Limited
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Thrombocytopenic Purpura (ITP)
Intervention: IgNextGen 10% (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: CSL Limited Official(s) and/or principal investigator(s):
Beng Chong, Professor, Principal Investigator, Affiliation: The St George Hospital (NSW, Australia)
Overall contact:
Beng Chong, Professor, Phone: 61-2-9350-2011, Email: beng.chong@unsw.edu.au
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Efficacy
Secondary outcome: Safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Beng Chong, Professor, Phone: 61-2-9350-2011, Email: beng.chong@unsw.edu.au
Canberra Hospital, Canberra, Australian Capital Territory 2605, Australia; Recruiting
Michael Pidcock, Dr, Phone: 61-2-6244-2222
Michael Pidcock, Dr, Principal Investigator
St George Hospital, Sydney, New South Wales 2217, Australia; Recruiting
Beng Chong, Professor, Phone: 61-2-9350-2011
Beng Chong, Professor, Principal Investigator
Royal Prince Alfred Hospital, Sydney, New South Wales 2050, Australia; Recruiting
John Gibson, Ass. Professor, Phone: 61-2-9515-8031
John Gibson, Ass. Prof, Principal Investigator
Princess Alexandra Hospital, Brisbane, Queensland 4102, Australia; Recruiting
Robert Bird, Dr, Phone: 61-7-3240-2425
Robert Bird, Dr, Principal Investigator
Redcliffe Hospital, Brisbane, Queensland, Australia; Recruiting
Peter Wood, Dr, Email: p.wood@uq.net.au
Peter Wood, Dr, Principal Investigator
Royal Adelaide Hospital, Adelaide, South Australia, Australia; Recruiting
Loy Jay, Dr
John Lloyd, Assoc. Professor, Principal Investigator
Monash Medical Centre, Melbourne, Victoria 3168, Australia; Recruiting
Eng Gan, Assoc. Professor, Phone: 61-3-9594-3477
Eng Gan, Assoc.Professor, Principal Investigator
Royal Perth Hospital, Perth, Western Australia, Australia; Recruiting
Ross Baker, Dr
Ross Baker, Dr, Principal Investigator
Additional Information
Starting date: June 2007
Ending date: December 2008
Last updated: September 18, 2008
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