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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntragamP | Drug | IntragamP - dosage based on previous dose of IntragamP prior to study entry. One cycle (Cycle 0)only administered, with dosage calculation based on body weight on Day 1 of the study and must be between 0.2-0.8 g/kg body weight. IntragamP to be administered intravenously. | ||
| Ig NextGen 10% | Drug | Ig NextGen 10% - dosage based on previous dose of IntragamP in Cycle 0. Dosage calculation to use body weight on Day 1 of Cycle 1 of the study and must be between 0.2-0.8 g/kg body weight. 7 cycles administered, and patients to be dosed at 3 to 4 week intervals (in accordance with previous dosage schedule with IntragamP). Ig NextGen 10% to be administered intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| IgG Trough Pharmacokinetics | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, Pharmacokinetics | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Bleasel, Dr | Melbourne Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flinders Medical Centre | Adelaide | South Australia | Australia | |||
| Royal Adelaide Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22212346 | Result | 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. doi: 10.1111/j.1445-5994.2011.02712.x. |
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| Adelaide |
| South Australia |
| Australia |
| The Alfred Hospital | Melbourne | Victoria | Australia |
| The Royal Melbourne Hospital | Melbourne | Victoria | Australia |