Clinical trial NCT00680446: Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
Official title: An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immune Deficiency
Keywords: Primary Immune Deficiency
Subcutaneous
Immunoglobulin G
Lead sponsor: CSL Limited
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 41
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a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

Primary outcomes:
measure: Rate, Severity and Relatedness of reported Adverse Events
timeFrame: Up to Four Years
Secondary outcomes:
measure: To monitor patient IgG trough levels while receiving Ig NextGen 16%
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Campbelltown
country: Australia
facility: Campbelltown Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: North Adelaide
country: Australia
facility: Women's & Children's Hospital
state: South Australia
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
Study officials:
affiliation: CSL
name: Medical and Research Director
role: STUDY_DIRECTOR
References: