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Sponsored by: |
CSL Limited |
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Information provided by: | CSL Limited |
ClinicalTrials.gov Identifier: | NCT00391131 |
This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using predominately chromatographic techniques. Eligible patients will switch from monthly intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial hospital training will be required for subcutaneous administration and then the patient will perform the infusion in their own home, returning once a month for a supervised infusion. Patients will be monitored on the study for up to 10 months to assess blood IgG levels and rate of serious bacterial infections.
Condition | Intervention | Phase |
---|---|---|
Primary Immunodeficiency (PID) |
Drug: IgNextGen 16% |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Centre, Open-Label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Subcutaneous Infusions of Ig NextGen 16% in Patients With Primary Immunodeficiency (PID). |
Estimated Enrollment: | 40 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 3 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
• Patients newly diagnosed with PID within six months of the Screening visit.
Patients with any of the following abnormal lab results:
Australia, South Australia | |
Royal Adelaide Hospital | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact: William Smith, Dr +61 8 8222 2953 | |
Principal Investigator: William Smith, Dr | |
Australia, Victoria | |
Royal Children's Hospital | Not yet recruiting |
Melbourne, Victoria, Australia, 3052 | |
Contact: Jo Smart, Dr +61 3 9345 5733 | |
Principal Investigator: Jo Smart, Dr | |
Frankston Hospital | Recruiting |
Frankston, Victoria, Australia | |
Contact: David Langton, Prof +61 3 9784 7980 | |
Principal Investigator: David Langton, Prof | |
Australia, Western Australia | |
Princess Margaret Hospital for Children | Recruiting |
Perth, Western Australia, Australia | |
Contact: Richard Loh, Dr +61 8 9340 8310 | |
Principal Investigator: Richard Loh, Dr | |
New Zealand | |
Christchurch Hospital | Recruiting |
Christchurch, New Zealand | |
Contact: John O'Donnell, Dr +64 3 364 0950 | |
Principal Investigator: John O'Donnell, Dr | |
Starship Children's Hospital | Recruiting |
Auckland, New Zealand | |
Contact: Jan Sinclair, Dr +64 9307 4913 | |
Principal Investigator: Jan Sinclair, Dr | |
Wellington Hospital | Recruiting |
Wellington, New Zealand | |
Contact: Richard Steele, Dr +64 4 385 5999 | |
Principal Investigator: Richard Steele, Dr | |
Auckland Hospital | Recruiting |
Auckland, New Zealand | |
Contact: Marianne Empson, Dr +64 9307 4949 | |
Principal Investigator: Marianne Empson, Dr |
Principal Investigator: | Marianne Empson, Dr | Auckland City Hospital |
Responsible Party: | CSL Limited ( Dr Darryl Maher ) |
Study ID Numbers: | CSLCT-SCIG-05-23 |
Study First Received: | October 20, 2006 |
Last Updated: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00391131 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
PID SCIG Ig Quality of Life Serious Bacterial Infections |
Bacterial Infections Quality of Life Immunologic Deficiency Syndromes |
Immune System Diseases |