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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680446
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
CSL Limited

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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).
Study Start Date : April 2008
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: 1 Drug: Immunoglobulin G (Ig NextGen 16%)
Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G
Other Name: Ig NextGen 16%

Primary Outcome Measures :
  1. Rate, Severity and Relatedness of reported Adverse Events [ Time Frame: Up to Four Years ]

Secondary Outcome Measures :
  1. To monitor patient IgG trough levels while receiving Ig NextGen 16% [ Time Frame: Up to 4 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680446

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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
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Study Director: Medical and Research Director CSL
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Responsible Party: CSL Limited Identifier: NCT00680446    
Other Study ID Numbers: CSLCT-SCIG-07-42
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by CSL Limited:
Primary Immune Deficiency
Immunoglobulin G
Additional relevant MeSH terms:
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Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Genetic Diseases, Inborn
Immunoglobulins, Intravenous
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs