Primary Immune Deficiency (PID) Clinical Trial
Official title:
A Multi-centre, Open-label, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of Ig NextGen 10% With Intragam P in Patients With Primary Immune Deficiency (PID)
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | 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 |
Lead Sponsor | Collaborator |
---|---|
CSL Limited |
Australia,
Bleasel K, Heddle R, Hissaria P, Stirling R, Stone C, Maher D. Pharmacokinetics and safety of Intragam 10 NF, the next generation 10% liquid intravenous immunoglobulin, in patients with primary antibody deficiencies. Intern Med J. 2012 Mar;42(3):252-9. do — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IgG Trough Pharmacokinetics | one month | No | |
Secondary | Safety and tolerability, Pharmacokinetics | 9 months | Yes |