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Study 11 of 17 for search of: | "Agammaglobulinemia" |
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Sponsored by: |
CSL Behring |
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Information provided by: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT00542997 |
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 |
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Common Variable Immunodeficiency X-Linked Agammaglobulinemia |
Drug: IgG with Proline (IgPro) |
Phase III |
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) |
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) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional criteria may apply and examination by an investigator is required to determine eligibility.
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 |
Principal Investigator: | Stephen Jolles, MD | University Hospital of Wales, Cardiff, UK |
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 |
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 |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |