CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
gammaglobulinbiological
Likely dose
gammaglobulin 132 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00661401
NCT00661401N/ACompleted
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Serum IgG Antibody to Streptococcus Pneumoniae, Haemophilus Influenzae Type b and Tetanus Toxoid in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin Infusions

Federal University of São Paulo·interventional·Posted Apr 18, 2008·Updated Apr 18, 2008

In Brief

A clinical study evaluating gammaglobulin for Common Variable Immunodeficiency and Agammaglobulinemia. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCommon Variable Immunodeficiency, Agammaglobulinemia
CountriesBrazil
CollaboratorsCSL Behring

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2008
Enrollment StartJan 1, 2002
Primary CompletionNov 1, 2002
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.2 years ago

Interventions

gammaglobulinbiological

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).