Subcutaneous Ig NextGen 16% in PID Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00391131
• Date of registration: 20/10/2006
• Prospective Registration: Yes
• Primary sponsor: CSL Limited
• Public title: Subcutaneous Ig NextGen 16% in PID Patients
• Scientific title: A Multi-centre, Open-label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Subcutaneous Infusions of Ig NextGen 16% in Patients With Primary Immunodeficiency (PID).
• Date of first enrolment: April 2007
• Target sample size: 35
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00391131
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Marianne Empson, Dr
• Affiliation: Auckland City Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- • 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.



Age minimum: 3 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency (PID)

Intervention(s)

Drug: IgNextGen 16%

Primary Outcome(s)

Efficacy [Time Frame: Continually from Visits 7 to 12 & monthly IgG troughs]

Secondary Outcome(s)

Safety, Tolerability, Quality of Life, Pharmacokinetics [Time Frame: Visits 0, 6, 9, and12]

Secondary ID(s)

CSLCT-SCIG-05-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors