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Sponsored by: |
CSL Limited |
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Information provided by: | CSL Limited |
ClinicalTrials.gov Identifier: | NCT00405184 |
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.
Condition | Intervention | Phase |
---|---|---|
Primary Immune Deficiency (PID) |
Drug: Ig NextGen 10% |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 20 |
Study Start Date: | June 2007 |
Study Completion Date: | November 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia | |
Flinders Medical Centre | |
Adelaide, South Australia, Australia | |
Australia, Victoria | |
The Royal Melbourne Hospital | |
Melbourne, Victoria, Australia | |
The Alfred Hospital | |
Melbourne, Victoria, Australia |
Principal Investigator: | Karl Bleasel, Dr | Melbourne Health |
Responsible Party: | CSL Limited ( Dr Darryl Maher ) |
Study ID Numbers: | CSLCT-PID-05-22 |
Study First Received: | November 27, 2006 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00405184 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
PID IVIg IntragamP |