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Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661401
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : April 18, 2008
CSL Behring
Information provided by:
Federal University of São Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Common Variable Immunodeficiency Agammaglobulinemia Biological: gammaglobulin Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2002
Actual Primary Completion Date : November 2002
Actual Study Completion Date : November 2002

Intervention Details:
  • Biological: gammaglobulin
    They were administered a polyvalent, pasteurized liquid immune globulin subcutaneously (human 16% Beriglobin ®, Germany) with doses ranging from 57 to 132 mg/kg/week in order to maintain the same dosage they received by intravenous route monthly previous to this protocol. After a wash-out period (15 weeks) of the subcutaneous immunoglobulin administration, blood was collected every 4 weeks immediately before infusions. The infusions were administered using battery-powered ambulatory syringe drivers together with 10 or 20 ml syringe and infusions sets according to a pre-defined protocol (Gardulf et al, 2006).
    Other Name: Beriglobin 17540311E

Primary Outcome Measures :
  1. Specific IgG levels were measured using ELISA. Adequate response was arbitrarily defined as equal to or higher than 1.3 mg/L to pneumococci (Sorensen RU et al 1998), 1.0 mg/L to Hib (Takano AO 1997) and 0.1 IU/mL to tetanus toxoid (Kayhtyh et al 1983). [ Time Frame: Samples from patients blood was collected every 4 weeks on 7 different occasions immediately before infusions.All patients were treated with subcutaneous immunoglobulin for 43 weeks. ]

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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • a diagnosis of a primary immunodeficiency disease with hypo-or agammaglobulinemia
  • diagnosis performed according to the WHO definitions
  • already been treated with Intravenous immunoglobulin or subcutaneous immunoglobulin for at least 6 months prior to enrollment into this study
  • documented IgG trough levels (at least two values), type of used IgG preparation, dosage and dosage interval over a period of 6 months prior to enrollment into this study

Exclusion Criteria:

  • history of hypersensitivity to the study medication or to drugs with similar chemical structures
  • hypersensitivity to IgA
  • subjects currently requiring <400 or > 600 mg/kg/b.w. immunoglobulin per month
  • subjects whose dosage intervals for IV Ig are < 3 weeks
  • know pregnancy or positive pregnancy test
  • nursing mothers
  • childbearing potential, if an acceptable birth control is not practiced
  • history of chronic or persisting renal insufficiency (serum creatinine above upper limit of normal)
  • history of chronic or persisting hepatic insufficiency (ALT> 2 times the upper limit of normal)
  • risk of developing acute renal failure (Diabetes mellitus, volume depletion, sepsis, paraproteinemia)
  • any symptomatic heart disease requiring treatment (NYHA class II or above)
  • history of seizure disorder
  • history or risk for occlusive vascular disease
  • indication of active hepatitis A, B, or C at screening (HAV-PCR, HBV-PCR, or HCV-PCR positive)
  • detection of HIV-1 PCR positive
  • likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
  • progressive fatal disease/life expectancy of less than 12 months
  • history of drug or alcohol abuse
  • pathological mental condition rendering the subject unable to understand, scope and possible consequences of the study and/or evidence of an uncooperative attitude
  • treatment with nephrotoxic drugs during the last 3 weeks
  • treatment with any other investigational drug in the last 3 months before study entry or likelihood of treatment with another investigational grug during the study period
  • evidence of uncooperative attitude
  • vaccination against hepatitis B within 3 months before enrollment into the study
  • former participation in this trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661401

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Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo
São Paulo, Brazil, Cep 04025-002
Sponsors and Collaborators
Federal University of São Paulo
CSL Behring
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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
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Responsible Party: Albertina da Rosa Borges Pizzamiglio, Federal University of São Paulo Identifier: NCT00661401    
Other Study ID Numbers: 310570
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: April 18, 2008
Last Verified: April 2008
Keywords provided by Federal University of São Paulo:
subcutaneous infusion
specific antibodies
primary antibody deficiency
Additional relevant MeSH terms:
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Common Variable Immunodeficiency
Immunologic Deficiency Syndromes
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunologic Factors
Physiological Effects of Drugs