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

Phase 3

Completed

• Conditions: Primary Immune Deficiency
• Interventions: Drug: Immunoglobulin G (Ig NextGen 16%)

• Registration Number: NCT00680446
• Lead Sponsor: CSL Limited

Brief Summary

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.

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-20
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Immunoglobulin G (Ig NextGen 16%)	-

Primary Outcome Measures

Name	Time	Method
Rate, Severity and Relatedness of reported Adverse Events	Up to Four Years

Secondary Outcome Measures

Name	Time	Method
To monitor patient IgG trough levels while receiving Ig NextGen 16%	Up to 4 years

Trial Locations

Locations (9)

Sydney Children's Hospital; 🇦🇺 Randwick, New South Wales, Australia

Women's & Children's Hospital; 🇦🇺 North Adelaide, South Australia, Australia

Auckland Hospital; 🇳🇿 Auckland, New Zealand

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand

Frankston Hospital; 🇦🇺 Frankston, Victoria, Australia

Campbelltown Hospital; 🇦🇺 Campbelltown, New South Wales, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Royal Children's Hospital; 🇦🇺 Parkville, Victoria, Australia

Wellington Hospital; 🇳🇿 Wellington, New Zealand