- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00661401
Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin
April 15, 2008 updated by: Federal University of São Paulo
Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil, Cep 04025-002
- Division of Allergy, Clinical Immunology and Rheumatology, Department of Pediatrics, Federal University of São Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 months to 73 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 Ceara
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (Actual)
November 1, 2002
Study Completion (Actual)
November 1, 2002
Study Registration Dates
First Submitted
April 14, 2008
First Submitted That Met QC Criteria
April 15, 2008
First Posted (Estimate)
April 18, 2008
Study Record Updates
Last Update Posted (Estimate)
April 18, 2008
Last Update Submitted That Met QC Criteria
April 15, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Blood Protein Disorders
- Primary Immunodeficiency Diseases
- Agammaglobulinemia
- Common Variable Immunodeficiency
- Physiological Effects of Drugs
- Immunologic Factors
- gamma-Globulins
Other Study ID Numbers
- 310570
- 315970
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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