Status:
COMPLETED
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
Lead Sponsor:
CSL Limited
Conditions:
Primary Immune Deficiency
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age \>3 years of age.
- PID patients receiving Ig replacement therapy.
- Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a suitable form of Ig replacement, for reasons such as: poor tolerability of IVIg, difficult venous access, or, preferred route of administration.
- Patient is capable of self-administering Ig NextGen 16%
Exclusion
- Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.
- Patients with known anaphylaxis reactions to immunoglobulin therapy.
- Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy.
- Patients with protein-losing enteropathies.
- Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect their treatment or the conduct of the trial.
- Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Females who are of child bearing potential must have a negative pregnancy test at screening.
- Patients unwilling to comply with the protocol.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00680446
Start Date
April 1 2008
End Date
May 1 2013
Last Update
June 19 2013
Active Locations (9)
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1
Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
2
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
Women's & Children's Hospital
North Adelaide, South Australia, Australia, 5006