The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.
This is a Phase 3, open label, multi-centre, study for patients requiring Ig replacement therapy. This study is a follow-on study to patients who have completed the CSLCT-SCIG-05-23 clinical trial and wish to continue subcutaneous treatment with Ig NextGen 16% . Additionally, patients currently receiving IVIg with unacceptable adverse reactions or unable to tolerate IVIg as well as patients receiving alternate IG products via the SC route may be enrolled in this study. Patients must not be eligible for any of the Sponsor's ongoing PID studies that are still open to enrolment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G
Campbelltown Hospital
Campbelltown, 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
Rate, Severity and Relatedness of reported Adverse Events
Time frame: Up to Four Years
To monitor patient IgG trough levels while receiving Ig NextGen 16%
Time frame: Up to 4 years
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Frankston Hospital
Frankston, Victoria, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Wellington Hospital
Wellington, New Zealand