Status:
COMPLETED
Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
Lead Sponsor:
CSL Limited
Conditions:
Primary Immune Deficiency (PID)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will swi...
Eligibility Criteria
Inclusion
- Clinical diagnosis of PID
- = or \>6 month use of Intragam P at three- or four-weekly intervals
- = or \>6 month history of IgG trough levels of ≥ 5 g/L
Exclusion
- Newly diagnosed PID within six months prior to Screening
- Known selective IgA deficiency or antibodies to IgA
- Immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids
- Protein-losing enteropathies, or kidney diseases
- History of malignancies of lymphoid cells
- Any of the following laboratory results at Screening:
- Serum Creatinine \> 1.5 times the upper normal limit (UNL)
- AST or ALT concentration \> 2.5 times the UNL
- Albumin \< 25 g/L
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00405184
Start Date
May 1 2007
End Date
July 1 2008
Last Update
June 7 2012
Active Locations (4)
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1
Flinders Medical Centre
Adelaide, South Australia, Australia
2
Royal Adelaide Hospital
Adelaide, South Australia, Australia
3
The Alfred Hospital
Melbourne, Victoria, Australia
4
The Royal Melbourne Hospital
Melbourne, Victoria, Australia