Trial document




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  DRKS00010561

Trial Description

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Title

Sustained infections under substitution of IgG (Immunoglobuline G)

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Trial Acronym

SINUS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In the SINUS study, patients with PID (primary immunodeficiency) will complete a patient questionnaire one time regarding their current health situation focusing on infection susceptibility in spite of immunoglobulin substitution therapy.
In addition the questionnaire will evaluate the patients' interest in a new therapeutic immunoglobulin regimen and the feasibility of this regimen in a pharmaceutical industry initiated therapeutic trial.

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Brief Summary in Scientific Language

Patients with common variable immunodeficiency (CVID) suffer from disturbed antibody generation. At least two, but often all three (IgG, IgA, IgM) main classes of antibodies are affected. During IgG substitution therapy usually the pathological infection susceptibility improves and particularly the occurrence of bacterial pneumonias decreases. The general therapy consists of an intravenous or subcutaneous application of immunoglobulin, just containing IgG.
However, in ca. 30% of the patients upper airways infections (especially sinusitis) persist despite regular replacement therapy (Gathmann et al, JACI 2015). This is possibly related to still lacking IgM and IgA, which are the main immunoglobulin classes secreted at mucous membranes. There are already immunoglobulin products available containing IgM and IgA. However due to short half-life of IgA and IgM they have to be applied in shorter intervals than pure IgG compounds. It remains unclear to what extend persistent infections of the upper airways affect the patients´ quality of life and if patients are willing to receive an intravenous immunoglobulin therapy even weekly or biweekly.
In the SINUS study patients with CVID will complete a patient questionnaire in regard to their current health situation focusing on infection susceptibility in spite of immunoglobulin substitution therapy (intravenous of subcutaneous). The questionnaire seeks to explore the impact on the quality of life by these kind of infections and the patients' willingness regarding more frequent intravenous immunoglobulin applications to control the infections.
In addition the questionnaire will evaluate the patients´ interest in a new immunoglobulin therapy and thus the feasibility of a respective therapeutic trial.

Patients with CVID (common variable immunodeficiency) will complete one time a questionnaire regarding their current health situation focusing on 1) infection susceptibility in spite of immunoglobulin substitution therapy (intravenous of subcutaneous), 2) impairment of quality life by these infections and 3) the patients' willingness to receive intravenous immunoglobulin infusions more frequently to control the infections.


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Organizational Data

  •   DRKS00010561
  •   2016/05/25
  •   [---]*
  •   yes
  •   Approved
  •   168/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   D83.0 -  Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
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Interventions/Observational Groups

  •   Patients with CVID (common variable immunodeficiency) complete one-time a questionnaire in terms of their current health situation focusing on infect susceptibility in spite of immunoglobuline substitution therapy (intravenous of subcutaneous), on impairment of life quality by these kind of infects and on the patients willingness to more frequent immunoglobuline infusions to control the infections.patients receive questionnaire
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Screening
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Prevalence of persistent infection suceptibility despite immunoglobuline substitution therapy

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Secondary Outcome

•Willingness of patients with persistent infection susceptibility in spite of standard immunoglobulin substitution therapy (intravenous or subcutanous) to receive an alternative intravenous immunoglobuline supportive therapy with one- or two-weekly application

•Association of persistent infection susceptibility in spite of immunoglobulin substitution therapy with reduced IgM and IgA serum level


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/06/01
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

diagnosis of PID (primary immunodeficiency) with antibody deficiency,
male and female patients,
18 years,
understanding of German language,
informed consent available

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Exclusion Criteria

no

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Addresses

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    • Universitätsklinikum FreiburgCentrum für Chronische Immundefizienz (CCI)
    • Mr.  Prof. Dr. med.  Klaus  Warnatz 
    • Breisacher Str. 115
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgCentrum für Chronische Immundefizienz (CCI)
    • Mr.  Prof. Dr. med.  Klaus  Warnatz 
    • Breisacher Str. 115
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgCentrum für Chronische Immundefizienz (CCI)
    • Mr.  Prof. Dr. med.  Klaus  Warnatz 
    • Breisacher Str. 115
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Biotest AG
    • Landsteinerstraße 5
    • 63303  Dreieich
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/15
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.