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

This study has been completed.
Sponsor:
Collaborator:
CSL Behring
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00661401
First received: April 14, 2008
Last updated: April 15, 2008
Last verified: April 2008
  Purpose

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
Common Variable Immunodeficiency
Agammaglobulinemia
Biological: gammaglobulin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

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)
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
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661401

Locations
Brazil
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
Investigators
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
  More Information

Publications:
Responsible Party: Albertina da Rosa Borges Pizzamiglio, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00661401     History of Changes
Other Study ID Numbers: 310570, 315970
Study First Received: April 14, 2008
Last Updated: April 15, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
gammaglobulin
subcutaneous infusion
specific antibodies
primary antibody deficiency

Additional relevant MeSH terms:
Agammaglobulinemia
Common Variable Immunodeficiency
Immunologic Deficiency Syndromes
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Gamma-Globulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014