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Study 9 of 17 for search of: | "Agammaglobulinemia" |
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Sponsors and Collaborators: |
Federal University of São Paulo CSL Behring |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00661401 |
Objective: Measure serum IgG antibody to Streptococcus pneumoniae serotypes 1, 3, 5, 6B, 9V e 14, Haemophilus influenzae type b and tetanus toxoid in patients with primary antibody deficiencies who were treated with subcutaneous immunoglobulin infusions.
Condition | Intervention |
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Common Variable Immunodeficiency Agammaglobulinemia |
Biological: gammaglobulin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions |
Enrollment: | 5 |
Study Start Date: | January 2002 |
Study Completion Date: | November 2002 |
Primary Completion Date: | November 2002 (Final data collection date for primary outcome measure) |
Therapy with polyvalent immunoglobulin (Ig) has been established as the standard therapy for antibody deficiencies for several decades now. Although subcutaneous infusions were originally proposed as an alternative to intramuscular injections, more recently, this method has been proven as a safe and convenient method for providing immunoglobulin levels in adults and children. Subcutaneous administration of immunoglobulins has some clinical advantages over intravenous immunoglobulin infusions (IVIG) , including a more benign side effect profile, better sustained levels of IgG in the blood and reduced cost. An additional benefit is an improvement in the quality of life, which is in part secondary to the feasibility of the patients to administer it themselves at home. The most common infections in primary antibody deficiency patients involves encapsulated bacteria, mainly Streptococcus pneumoniae and Haemophilus influenzae type b. The aim of this study is to verify if patients with antibody deficiency receiving subcutaneous immunoglobulin (SCIG) infusions keep protective antibody levels to Streptococcus pneumoniae, Haemophilus influenzae type b (Hib) and tetanus toxoid.
Ages Eligible for Study: | 2 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo | |
São Paulo, Brazil, Cep 04025-002 |
Study Director: | Beatriz T Costa Carvalho, md PhD | Federal University of São Paulo |
Study Chair: | Charles K Naspitz, md MSc | Federal University of São Paulo |
Principal Investigator: | Albertina RB Pizzamiglio, md MSc | Federal University of São Paulo |
Study Director: | Aparecida T Nagao-Dias | Federal University of Ceará |
Responsible Party: | Federal University of São Paulo ( Albertina da Rosa Borges Pizzamiglio ) |
Study ID Numbers: | 310570, 315970 |
Study First Received: | April 14, 2008 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00661401 |
Health Authority: | Brazil: National Committee of Ethics in Research |
gammaglobulin subcutaneous infusion specific antibodies primary antibody deficiency |
Gamma-Globulins Agammaglobulinemia Haemophilus influenzae Common variable immunodeficiency Blood Protein Disorders Hematologic Diseases Benzocaine Tetanus |
Immunologic Deficiency Syndromes Lymphatic Diseases Antibodies Influenza, Human Lymphoproliferative Disorders Pneumonia Common Variable Immunodeficiency Immunoglobulins |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |