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

NCT00661401 | Completed DMC

• 2 other identifiers: 310570315970
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Variable Immunodeficiency; Agammaglobulinemia

Keywords

gammaglobulin; subcutaneous infusion; specific antibodies; primary antibody deficiency

Outcome Measures

Primary Outcomes (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).

  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.

Interventions

gammaglobulin BIOLOGICAL

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).

Also known as: Beriglobin 17540311E

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• CSL Behring: collaborator

Study Sites (1)

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

São Paulo, São Paulo, Cep 04025-002, Brazil

Location

Related Publications (4)

• 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.

  PMID: 16758340 BACKGROUND

• 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.

  PMID: 9723664 BACKGROUND

• 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.

  PMID: 6602191 BACKGROUND

• 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.

  PMID: 11332669 BACKGROUND

MeSH Terms

Conditions

Common Variable Immunodeficiency; Agammaglobulinemia; Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Immunologic Deficiency Syndromes; Immune System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Beatriz T Costa Carvalho, md PhD

  Federal University of São Paulo

  STUDY DIRECTOR

• Charles K Naspitz, md MSc

  Federal University of São Paulo

  STUDY CHAIR

• Albertina RB Pizzamiglio, md MSc

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Aparecida T Nagao-Dias

  Federal University of Ceará

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 18, 2008
• Study Start: January 1, 2002
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: April 18, 2008

Record last verified: 2008-04

Locations

BR (1)