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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

CSL Limited

ClinicalTrials.gov Identifier:

NCT00680446

First received: May 16, 2008

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2008

Last Updated Date

March 11, 2013

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Rate, Severity and Relatedness of reportd Adverse Events [ Time Frame: Up to Four Years ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00680446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Immune Deficiency

Intervention ^ICMJE

Drug: Immunoglobulin G (Ig NextGen 16%)

Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G

Other Name: Ig NextGen 16%

Study Arm (s)

Experimental: 1

Intervention: Drug: Immunoglobulin G (Ig NextGen 16%)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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%

Exclusion Criteria:

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.

Gender

Both

Ages

3 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, New Zealand

Administrative Information

NCT Number ^ICMJE

NCT00680446

Other Study ID Numbers ^ICMJE

CSLCT-SCIG-07-42

Has Data Monitoring Committee

Responsible Party

CSL Limited

Study Sponsor ^ICMJE

CSL Limited

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical and Research Director

CSL

Information Provided By

CSL Limited

Verification Date

March 2013

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

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