Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency

An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).

The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.

Study Overview

• Status: Completed
• Conditions: Primary Immune Deficiency
• Intervention / Treatment: Drug: Immunoglobulin G (Ig NextGen 16%)

Detailed Description

This is a Phase 3, open label, multi-centre, study for patients requiring Ig replacement therapy. This study is a follow-on study to patients who have completed the CSLCT-SCIG-05-23 clinical trial and wish to continue subcutaneous treatment with Ig NextGen 16% . Additionally, patients currently receiving IVIg with unacceptable adverse reactions or unable to tolerate IVIg as well as patients receiving alternate IG products via the SC route may be enrolled in this study. Patients must not be eligible for any of the Sponsor's ongoing PID studies that are still open to enrolment.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Campbelltown, New South Wales, Australia, 2560
      • Campbelltown Hospital
    • Randwick, New South Wales, Australia, 2031
      • Sydney Children's Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • North Adelaide, South Australia, Australia, 5006
      • Women's & Children's Hospital
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Frankston Hospital
    • Parkville, Victoria, Australia, 3052
      • Royal Children's Hospital
• New Zealand
  • Auckland, New Zealand
    • Auckland Hospital
  • Christchurch, New Zealand
    • Christchurch Hospital
  • Wellington, New Zealand
    • Wellington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >3 years of age.
2. PID patients receiving Ig replacement therapy.
3. Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a suitable form of Ig replacement, for reasons such as: poor tolerability of IVIg, difficult venous access, or, preferred route of administration.
4. Patient is capable of self-administering Ig NextGen 16%

Exclusion Criteria:

1. Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.
2. Patients with known anaphylaxis reactions to immunoglobulin therapy.
3. Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy.
4. Patients with protein-losing enteropathies.
5. Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect their treatment or the conduct of the trial.
6. 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.
7. Patients unwilling to comply with the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Immunoglobulin G (Ig NextGen 16%); Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G; Other Names: Ig NextGen 16%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate, Severity and Relatedness of reported Adverse Events	Up to Four Years

Secondary Outcome Measures

Outcome Measure	Time Frame
To monitor patient IgG trough levels while receiving Ig NextGen 16%	Up to 4 years

Collaborators and Investigators

• Sponsor: CSL Limited
• Investigators: Study Director: Medical and Research Director, CSL

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 16, 2008
• First Submitted That Met QC Criteria: May 19, 2008
• First Posted (Estimate): May 20, 2008

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Subcutaneous; Immunoglobulin G; Primary Immune Deficiency
• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Immunoglobulin G
• Other Study ID Numbers: CSLCT-SCIG-07-42