Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID) Requiring IgG Replacement Therapy - Full Text View

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00719680

Purpose

The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.

Condition	Intervention	Phase
Primary Immune Deficiency	Biological: IgG with Proline	Phase III

Drug Information available for: Immunoglobulins Globulin, Immune 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 (PID)

Further study details as provided by CSL Behring:

Primary Outcome Measures:

The rate of serious bacterial infections per year [ Time Frame: annualized ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total serum IgG trough levels [ Time Frame: weekly ] [ Designated as safety issue: No ]
Number of infection episodes [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]
Number of days of hospitalization due to infection [ Time Frame: over the study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IgPro: Experimental	Biological: IgG with Proline Dose will be the same as in the previous pivotal study ZLB04_009CR infused subcutaneously weekly or twice a week (in the latter case, half of a weekly dose will be used)

Eligibility

Ages Eligible for Study:	2 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with primary humoral immunodeficiency who have participated in the study ZLB04_009CR, namely with a diagnosis of CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA as defined by PAGID and ESID
Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
Written informed consent

Exclusion Criteria:

Ongoing serious bacterial infection at the time of screening
Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
Other significant medical conditions that could increase the risk to the patient
Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
A positive result at screening on any of the following viral markers: HIV, HCV or HBV
ASAT or ALAT concentration > 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04_009CR
Creatinine concentration > 1.5 times UNL at Completion Visit of study ZLB04_009CR
Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719680

Locations

United States, Texas

Dallas, Texas, United States

Sponsors and Collaborators

CSL Behring

More Information

Responsible Party:	CSL Behring ( Peter Kiessling, Program Director )
Study ID Numbers:	1473
Study First Received:	July 21, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00719680
Health Authority:	United States: Food and Drug Administration

Keywords provided by CSL Behring:

CVID
XLA

Study placed in the following topic categories:

Antibodies
Immunologic Deficiency Syndromes
Immunoglobulins

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009