Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy - Full Text View

Purpose

This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.

Condition	Intervention	Phase
Primary Immunodefficiency (PID)	Biological: IgG with Proline (IgPro)	Phase III

ChemIDplus related topics:

Globulin, Immune Immunoglobulins Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgG With Proline - IgPro in Subjects With Primary Immunodeficiency (IgPro EU Extension Study)

Further study details as provided by CSL Behring:

Secondary Outcome Measures:

Rate, severity and relatedness of any adverse events (AEs) per infusion and subject
Changes in vital signs
Changes in routine laboratory parameters (blood chemistry, hematology, urinalysis) as compared to baseline assessments
Total serum IgG trough levels
Rate of clinically documented serious bacterial infections (SBIs)
Number of infection episodes
Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections
Number of days of hospitalization due to infections
Use of antibiotics for infection prophylaxis and treatment
Health related quality of life

Estimated Enrollment:	36
Study Start Date:	August 2008
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

SC administration by the subject/parent/guardian with the planned weekly dose of IgPro to be the same as the subject's last dose recommended by the investigator in study ZLB06_001CR.

Eligibility

Ages Eligible for Study:	4 Years to 67 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common variable immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and the European Society for Immunodeficiencies (ESID), or X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or autosomal recessive agammaglobulinemia who have participated in the study ZLB06_001CR and who have tolerated IgPro well
Written informed consent

Exclusion Criteria:

Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total urine protein concentration > 0.2g/L)
Other significant medical conditions that could increase the risk to the subject
Females who are pregnant, breast feeding or planning a pregnancy during the course of the study
Participation in a study with an investigational medicinal product within three months prior to enrollment, except for ZLB06_001CR
Evidence of uncooperative attitude
Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study
Subjects who are employees at the investigational site, relatives or spouse of the investigator

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	CSL Behring ( Brigitte Kuenzle )
Study ID Numbers:	1472, ZLB07_002CR
First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751621
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Romania: National Medicines Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by CSL Behring:

Immune globulin subcutaneous

SCIG

primary immunodeficiency

PID

Study placed in the following topic categories:

Immunologic Deficiency Syndromes

Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00751621