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Subcutaneous Ig NextGen 16% in PID Patients

Primary Purpose

Primary Immunodeficiency (PID)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IgNextGen 16%
Sponsored by
CSL Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immunodeficiency (PID) focused on measuring PID, SCIG, Ig, Quality of Life, Serious Bacterial Infections

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Canberra Hospital
  • John Hunter Hospital
  • Sydney Children's Hospital
  • Royal Adelaide Hospital
  • Women's & Children's Hospital
  • Frankston Hospital
  • Royal Children's Hospital
  • Princess Margaret Hospital for Children
  • Auckland Hospital
  • Starship Children's Hospital
  • Christchurch Hospital
  • Wellington Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ig NextGen 16%

Arm Description

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

Safety, Tolerability, Quality of Life, Pharmacokinetics

Full Information

First Posted
October 20, 2006
Last Updated
June 5, 2012
Sponsor
CSL Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00391131
Brief Title
Subcutaneous Ig NextGen 16% in PID Patients
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).
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Limited

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency (PID)
Keywords
PID, SCIG, Ig, Quality of Life, Serious Bacterial Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ig NextGen 16%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IgNextGen 16%
Intervention Description
IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
Continually from Visits 7 to 12 & monthly IgG troughs
Secondary Outcome Measure Information:
Title
Safety, Tolerability, Quality of Life, Pharmacokinetics
Time Frame
Visits 0, 6, 9, and12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Empson, Dr
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Sydney Children's Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Women's & Children's Hospital
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Royal Children's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Auckland Hospital
City
Auckland
Country
New Zealand
Facility Name
Starship Children's Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22526590
Citation
Empson MB, Tang ML, Pearce LK, Rozen L, Gold MS, Katelaris CH, Langton D, Smart J, Smith WB, Steele RH, Ziegler JB, Maher D. Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam(R), in primary immunodeficiency. J Clin Immunol. 2012 Oct;32(5):897-906. doi: 10.1007/s10875-011-9641-4. Epub 2012 Apr 13.
Results Reference
result

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Subcutaneous Ig NextGen 16% in PID Patients

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