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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12
The Canberra Hospital
Garran, Australian Capital Territory, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Sydney Children's Hospital
Randwick, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Women's & Children's Hospital
North Adelaide, South Australia, Australia
Frankston Hospital
Frankston, Victoria, Australia
Royal Children's Hospital
Melbourne, Victoria, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Auckland Hospital
Auckland, New Zealand
Starship Children's Hospital
Auckland, New Zealand
...and 2 more locations
Efficacy
Time frame: Continually from Visits 7 to 12 & monthly IgG troughs
Safety, Tolerability, Quality of Life, Pharmacokinetics
Time frame: Visits 0, 6, 9, and12
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