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

Primary Immune Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680446
• Other study ID #: CSLCT-SCIG-07-42
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2008
• Last updated: June 18, 2013
• Start date: April 2008
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: CSL Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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 Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency

Intervention

Drug:
• Immunoglobulin G (Ig NextGen 16%)
Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Campbelltown Hospital	Campbelltown	New South Wales
Australia	Frankston Hospital	Frankston	Victoria
Australia	Women's & Children's Hospital	North Adelaide	South Australia
Australia	Royal Children's Hospital	Parkville	Victoria
Australia	Sydney Children's Hospital	Randwick	New South Wales
New Zealand	Auckland Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Wellington Hospital	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
CSL Limited

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate, Severity and Relatedness of reported Adverse Events		Up to Four Years	Yes
Secondary	To monitor patient IgG trough levels while receiving Ig NextGen 16%		Up to 4 years	No