Status:
COMPLETED
Subcutaneous Ig NextGen 16% in PID Patients
Lead Sponsor:
CSL Limited
Conditions:
Primary Immunodeficiency (PID)
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
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 liqui...
Eligibility Criteria
Inclusion
- Males or females 3 years of age or greater and at least 13 kg at enrolment.
- PID patients receiving Ig replacement therapy, with a diagnosis of X-linked agammaglobulinemia (XLA) or Common Variable immunodeficiency (CVID) with severe hypogammaglobulinemia.
- Patients who have received a consistent dose of Intragam®P at 3-, 4-, 5- or 6-weekly intervals, within the range of 0.2 - 0.6 g/kg body weight, for at least six months prior to the Screening visit.
- Patients must have maintained IgG trough serum level of ≥ 5 g/L during the six months prior to Visit 0, with at least two trough levels to have been documented during this period.
- Patients and/or their legally acceptable representative/guardian must give written informed consent to participate in the study and must understand the nature of the study and must be willing to comply with all protocol requirements
Exclusion
- • Patients newly diagnosed with PID within six months of the Screening visit.
- Patients with known or suspected severe hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy or other blood products
- Patients with known selective IgA deficiency or antibodies to IgA
- Patients receiving immunosuppressive treatment other than topical and/or inhaled steroids and low dose oral steroids.
- 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 with protein-losing enteropathies, and kidney diseases with substantial proteinuria
- Patients with malignancies of lymphoid cells such as chronic lymphocytic leukaemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma.
- Patients who have within 30 days priors to the study screening visit, participated in a clinical study or used an investigational compound (eg: a new chemical entity not registered for clinical use).
- Patients with any of the following abnormal lab results:
- Serum creatinine \>1.5 x Upper limit of Normal (ULN).
- Serum ALT \& AST \> 2.5 x ULN.
- Albumin \< 25 g/L
- Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect the conduct of the trial.
- Patients who are not willing or are unable to comply with protocol.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00391131
Start Date
April 1 2007
End Date
October 1 2009
Last Update
June 7 2012
Active Locations (12)
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1
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
2
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
3
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
4
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000