Subcutaneous Ig NextGen 16% in PID Patients
- Conditions
- Primary Immunodeficiency (PID)
- Interventions
- Drug: IgNextGen 16%
- Registration Number
- NCT00391131
- Lead Sponsor
- CSL Limited
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
-
Inclusion Criteria:
- 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
-
• 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.
-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ig NextGen 16% IgNextGen 16% -
- Primary Outcome Measures
Name Time Method Efficacy Continually from Visits 7 to 12 & monthly IgG troughs
- Secondary Outcome Measures
Name Time Method Safety, Tolerability, Quality of Life, Pharmacokinetics Visits 0, 6, 9, and12
Trial Locations
- Locations (12)
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Auckland Hospital
🇳🇿Auckland, New Zealand
Starship Children's Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Sydney Children's Hospital
🇦🇺Randwick, New South Wales, Australia
Women's & Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Royal Children's Hospital
🇦🇺Melbourne, Victoria, Australia
Wellington Hospital
🇳🇿Wellington, New Zealand