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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Limited
ClinicalTrials.gov Identifier:
NCT00680446
First received: May 16, 2008
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Primary Immune Deficiency
Drug: Immunoglobulin G (Ig NextGen 16%)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).

Resource links provided by NLM:


Further study details as provided by CSL Limited:

Primary Outcome Measures:
  • Rate, Severity and Relatedness of reported Adverse Events [ Time Frame: Up to Four Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To monitor patient IgG trough levels while receiving Ig NextGen 16% [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: April 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Immunoglobulin G (Ig NextGen 16%)
Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G
Other Name: Ig NextGen 16%

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680446

Locations
Australia, New South Wales
Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Women's & Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Frankston Hospital
Frankston, Victoria, Australia, 3199
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
New Zealand
Auckland Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Wellington Hospital
Wellington, New Zealand
Sponsors and Collaborators
CSL Limited
Investigators
Study Director: Medical and Research Director CSL
  More Information

No publications provided

Responsible Party: CSL Limited
ClinicalTrials.gov Identifier: NCT00680446     History of Changes
Other Study ID Numbers: CSLCT-SCIG-07-42
Study First Received: May 16, 2008
Last Updated: June 18, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Keywords provided by CSL Limited:
Primary Immune Deficiency
Subcutaneous
Immunoglobulin G

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014