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

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00542997

Purpose

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgG with proline (IgPro) in subjects with PID. As the primary study objective, the dose given to the subjects should result in sustained IgG trough levels comparable to the previous IgG treatment.

Condition	Intervention	Phase
Common Variable Immunodeficiency X-Linked Agammaglobulinemia	Drug: IgG with Proline (IgPro)	Phase III

Genetics Home Reference related topics: aceruloplasminemia X-linked agammaglobulinemia

Drug Information available for: Immunoglobulins Globulin, Immune Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics 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:

Total serum IgG trough levels

Secondary Outcome Measures:

Rate of clinically documented serious bacterial infections
Number of infection episodes
Use of antibiotics for infection prophylaxis and treatment
Adverse events

Estimated Enrollment:	36
Study Start Date:	September 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with primary humoral immunodeficiency, namely with a diagnosis of CVID as defined by PAGID and ESID, XLA as defined by PAGID and ESID, or Autosomal Recessive Agammaglobulinemia
Chest X-ray or CT Scan obtained within 1 year prior to enrolment

Exclusion Criteria:

Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin replacement therapy
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
Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA

Additional criteria may apply and examination by an investigator is required to determine eligibility.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542997

Locations

France

Paris, France
Germany

Berlin, Germany

Hannover, Germany

Leipzig, Germany

Munich, Germany
Italy

Brescia, Italy
Spain

Madrid, Spain
Sweden

Goteborg, Sweden
Switzerland

Berne, Switzerland
United Kingdom

Cardiff, United Kingdom

London, United Kingdom

Sponsors and Collaborators

CSL Behring

Investigators

Principal Investigator:

Stephen Jolles, MD

University Hospital of Wales, Cardiff, UK

More Information

Responsible Party:	CSL Behring ( Program Director )
Study ID Numbers:	1460
Study First Received:	October 11, 2007
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00542997
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Lymphatic Diseases
Antibodies
Agammaglobulinemia
Common variable immunodeficiency
Hematologic Diseases
Blood Protein Disorders

X-linked agammaglobulinemia
Lymphoproliferative Disorders
Bruton type agammaglobulinemia
Common Variable Immunodeficiency
Immunologic Deficiency Syndromes
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009