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

NCT00680446 | Completed Phase 3

• 1 other identifier: CSLCT-SCIG-07-42
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 9

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.

Conditions

Primary Immune Deficiency

Keywords

Primary Immune Deficiency; Subcutaneous; Immunoglobulin G

Outcome Measures

Primary Outcomes (1)

• Rate, Severity and Relatedness of reported Adverse Events

  Up to Four Years

Secondary Outcomes (1)

• To monitor patient IgG trough levels while receiving Ig NextGen 16%

  Up to 4 years

Study Arms (1)

1

EXPERIMENTAL

Drug: Immunoglobulin G (Ig NextGen 16%)

Interventions

Immunoglobulin G (Ig NextGen 16%) DRUG

Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G

Also known as: Ig NextGen 16%

1

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>3 years of age.
• PID patients receiving Ig replacement therapy.
• Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a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.
• Patient is capable of self-administering Ig NextGen 16%

You may not qualify if:

• Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.
• Patients with known anaphylaxis reactions to immunoglobulin therapy.
• Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy.
• Patients with protein-losing enteropathies.
• 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.
• 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.
• Patients unwilling to comply with the protocol.

Sponsors & Collaborators

• CSL Limited: lead

Study Sites (9)

Campbelltown Hospital

Campbelltown, New South Wales, 2560, Australia

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Women's & Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Auckland Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Interventions

Immunoglobulin G

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical and Research Director

  CSL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

AU (6); NZ (3)