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

May 16, 2008
June 18, 2013
April 2008
May 2013   (final data collection date for primary outcome measure)
Rate, Severity and Relatedness of reported Adverse Events [ Time Frame: Up to Four Years ] [ Designated as safety issue: Yes ]
Rate, Severity and Relatedness of reportd Adverse Events [ Time Frame: Up to Four Years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00680446 on ClinicalTrials.gov Archive Site
To monitor patient IgG trough levels while receiving Ig NextGen 16% [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency
An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Immune Deficiency
Drug: Immunoglobulin G (Ig NextGen 16%)
Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G
Other Name: Ig NextGen 16%
Experimental: 1
Intervention: Drug: Immunoglobulin G (Ig NextGen 16%)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
3 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT00680446
CSLCT-SCIG-07-42
No
CSL Limited
CSL Limited
Not Provided
Study Director: Medical and Research Director CSL
CSL Limited
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP