Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
Phase 3
Completed
- Conditions
- Primary Immune Deficiency (PID)
- Registration Number
- NCT00405184
- Lead Sponsor
- CSL Limited
- 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 switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method IgG Trough Pharmacokinetics one month
- Secondary Outcome Measures
Name Time Method Safety and tolerability, Pharmacokinetics 9 months
Trial Locations
- Locations (4)
Flinders Medical Centre
🇦🇺Adelaide, South Australia, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
The Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Flinders Medical Centre🇦🇺Adelaide, South Australia, Australia