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

Primary Purpose

Common Variable Immunodeficiency, Agammaglobulinemia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
gammaglobulin
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Variable Immunodeficiency focused on measuring gammaglobulin, subcutaneous infusion, specific antibodies, primary antibody deficiency

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo

Outcomes

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).

Secondary Outcome Measures

Full Information

First Posted
April 14, 2008
Last Updated
April 15, 2008
Sponsor
Federal University of São Paulo
Collaborators
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT00661401
Brief Title
Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin
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 Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo
Collaborators
CSL Behring

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Variable Immunodeficiency, Agammaglobulinemia
Keywords
gammaglobulin, subcutaneous infusion, specific antibodies, primary antibody deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
gammaglobulin
Other Intervention Name(s)
Beriglobin 17540311E
Intervention Description
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).
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz T Costa Carvalho, md PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Charles K Naspitz, md MSc
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Albertina RB Pizzamiglio, md MSc
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aparecida T Nagao-Dias
Organizational Affiliation
Federal University of Ceará
Official's Role
Study Director
Facility Information:
Facility Name
Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
Cep 04025-002
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16758340
Citation
Gardulf A, Nicolay U, Asensio O, Bernatowska E, Bock A, Carvalho BC, Granert C, Haag S, Hernandez D, Kiessling P, Kus J, Pons J, Niehues T, Schmidt S, Schulze I, Borte M. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies--a prospective, multi-national study. J Clin Immunol. 2006 Mar;26(2):177-85. doi: 10.1007/s10875-006-9002-x. Epub 2006 Apr 26.
Results Reference
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PubMed Identifier
9723664
Citation
Sorensen RU, Leiva LE, Javier FC 3rd, Sacerdote DM, Bradford N, Butler B, Giangrosso PA, Moore C. Influence of age on the response to Streptococcus pneumoniae vaccine in patients with recurrent infections and normal immunoglobulin concentrations. J Allergy Clin Immunol. 1998 Aug;102(2):215-21. doi: 10.1016/s0091-6749(98)70089-2.
Results Reference
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PubMed Identifier
6602191
Citation
Kayhty H, Peltola H, Karanko V, Makela PH. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis. 1983 Jun;147(6):1100. doi: 10.1093/infdis/147.6.1100. No abstract available.
Results Reference
background
PubMed Identifier
11332669
Citation
Pichichero ME, Anderson EL, Rennels MB, Edwards KM, England JA. Fifth vaccination with dipthteria, tetanus and acellular pertussis is beneficial in four- to six-year-olds. Pediatr Infect Dis J. 2001 Apr;20(4):427-33. doi: 10.1097/00006454-200104000-00011.
Results Reference
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Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin

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