Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary Immunodeficiency - Full Text View

Sponsored by:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00680446

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 III

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).

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 ]

Estimated Enrollment:	50
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Immunoglobulin G (Ig NextGen 16%) Weekly or Bi-weekly subcutaneous administration of Immunoglobulin G

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:

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.

Contacts and Locations

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

Contacts

Contact: Connie Leggio

+61 3 9389 1413

connie.leggio@csl.com.au

Locations

Australia, Australian Capital Territory
Canberra Hospital	Not yet recruiting
Garran, Australian Capital Territory, Australia, 2605
Contact: Matthew Cook, Dr
Principal Investigator: Matthew Cook, Dr
Australia, New South Wales
Campbelltown Hospital	Enrolling by invitation
Campbelltown, New South Wales, Australia, 2560
John Hunter Hospital	Not yet recruiting
Newcastle, New South Wales, Australia, 2305
Contact: Glenn Reeves, Dr
Principal Investigator: Glenn Reeves, Dr
Sydney Children's Hospital	Not yet recruiting
Randwick, New South Wales, Australia, 2031
Contact: John Ziegler, Assoc.Prof
Principal Investigator: John Zeigler, Assoc.Prof
Australia, South Australia
Royal Adelaide Hospital	Active, not recruiting
Adelaide, South Australia, Australia, 5000
Women's & Children's Hospital	Active, not recruiting
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Frankston Hospital	Active, not recruiting
Frankston, Victoria, Australia, 3199
Royal Children's Hospital	Enrolling by invitation
Parkville, Victoria, Australia, 3052
New Zealand
Auckland Hospital	Recruiting
Auckland, New Zealand
Contact: Marianne Empson, Dr
Principal Investigator: Marianne Empson, Dr
Wellington Hospital	Recruiting
Wellington, New Zealand
Contact: Richard Steele, Dr
Principal Investigator: Richard Steele, Dr
Christchurch Hospital	Recruiting
Christchurch, New Zealand
Contact: John O'Donnell, Dr
Principal Investigator: John O'Donnell, Dr

Sponsors and Collaborators

CSL Limited

Investigators

Study Director:

Darryl Maher, Medicine

CSL

More Information

No publications provided

Responsible Party:	CSL Limited ( Dr Darryl Maher )
Study ID Numbers:	CSLCT-SCIG-07-42
Study First Received:	May 16, 2008
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00680446 History of Changes
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

Study placed in the following topic categories:

Antibodies
Immunologic Factors
Immunoglobulin G
Immunologic Deficiency Syndromes
Immunoglobulins

Additional relevant MeSH terms:

Antibodies
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Immunoglobulin G
Pharmacologic Actions
Immunologic Deficiency Syndromes
Immunoglobulins

ClinicalTrials.gov processed this record on May 07, 2009