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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00680446

Enrollment

Registered

2008-05-20

Start date

2008-04-30

Completion date

2013-05-31

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Deficiency

Keywords

Primary Immune Deficiency, Subcutaneous, Immunoglobulin G

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.

Interventions

DRUGImmunoglobulin G (Ig NextGen 16%)

Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

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 Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a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

Design outcomes

Primary

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

Secondary

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

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026