Subcutaneous Ig NextGen 16% in PID Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00391131
First received: October 20, 2006
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Primary Immunodeficiency (PID)
Drug: IgNextGen 16%
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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).

Resource links provided by NLM:


Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Efficacy [ Time Frame: Continually from Visits 7 to 12 & monthly IgG troughs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, Tolerability, Quality of Life, Pharmacokinetics [ Time Frame: Visits 0, 6, 9, and12 ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: April 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ig NextGen 16% Drug: IgNextGen 16%
IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391131

Locations
Australia, Australian Capital Territory
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Women's & Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Frankston Hospital
Frankston, Victoria, Australia
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
New Zealand
Auckland Hospital
Auckland, New Zealand
Starship Children's Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Wellington Hospital
Wellington, New Zealand
Sponsors and Collaborators
CSL Limited
Investigators
Principal Investigator: Marianne Empson, Dr Auckland City Hospital
  More Information

Publications:
Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00391131     History of Changes
Other Study ID Numbers: CSLCT-SCIG-05-23
Study First Received: October 20, 2006
Last Updated: June 5, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by CSL Limited:
PID
SCIG
Ig
Quality of Life
Serious Bacterial Infections

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014