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Subcutaneous Ig NextGen 16% in PID Patients
This study is currently recruiting participants.
Verified by CSL Limited, September 2008
Sponsored by: CSL Limited
Information provided by: CSL Limited
ClinicalTrials.gov Identifier: NCT00391131
  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 III

MedlinePlus related topics: Bacterial Infections
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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).

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 ]

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00391131

Locations
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: William Smith, Dr     +61 8 8222 2953        
Principal Investigator: William Smith, Dr            
Australia, Victoria
Royal Children's Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3052
Contact: Jo Smart, Dr     +61 3 9345 5733        
Principal Investigator: Jo Smart, Dr            
Frankston Hospital Recruiting
Frankston, Victoria, Australia
Contact: David Langton, Prof     +61 3 9784 7980        
Principal Investigator: David Langton, Prof            
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia
Contact: Richard Loh, Dr     +61 8 9340 8310        
Principal Investigator: Richard Loh, Dr            
New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand
Contact: John O'Donnell, Dr     +64 3 364 0950        
Principal Investigator: John O'Donnell, Dr            
Starship Children's Hospital Recruiting
Auckland, New Zealand
Contact: Jan Sinclair, Dr     +64 9307 4913        
Principal Investigator: Jan Sinclair, Dr            
Wellington Hospital Recruiting
Wellington, New Zealand
Contact: Richard Steele, Dr     +64 4 385 5999        
Principal Investigator: Richard Steele, Dr            
Auckland Hospital Recruiting
Auckland, New Zealand
Contact: Marianne Empson, Dr     +64 9307 4949        
Principal Investigator: Marianne Empson, Dr            
Sponsors and Collaborators
CSL Limited
Investigators
Principal Investigator: Marianne Empson, Dr Auckland City Hospital
  More Information

Responsible Party: CSL Limited ( Dr Darryl Maher )
Study ID Numbers: CSLCT-SCIG-05-23
Study First Received: October 20, 2006
Last Updated: September 18, 2008
ClinicalTrials.gov Identifier: NCT00391131  
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

Study placed in the following topic categories:
Bacterial Infections
Quality of Life
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009