Trial document




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  DRKS00008784

Trial Description

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Title

A randomised, cross-over study to compare quality of life and satisfaction in primary immunodeficient patients treated with subcutaneous injections of Gammanorm® 165 mg/mL administered with two different delivery devices:
injections using pump or rapid push

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Trial Acronym

GAN-06

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URL of the Trial

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Brief Summary in Lay Language

In this study the quality of life and satisfaction of subcutaneous treatment with Gammanorm® 165 mg/mL administered with two different delivery devices (subcoutaneously injections using a syringe or using a pump) are compared.
The potential participants are patients with primary immunodeficiency for a lifelong treatment. The rapid application using a syringe is expected to be interferior to patient satisfaction regarding the use of the pump. The efficacy and tolerability will be discribed by delivery device.

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Brief Summary in Scientific Language

The study will be a comparative, interventional, multicentre, prospective, longitudinal, randomised, open-label, and cross-over design conducted in patients with PID and receiving Gammanorm® 165 mg/mL subcutaneously at home over two periods of three months. Patient satisfaction will be compared according to the delivery device for subcutaneous injections of Gammanorm® 165 mg/mL (automatic pump or syringe).

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Organizational Data

  •   DRKS00008784
  •   2015/07/01
  •   2015/07/01
  •   no
  •   Approved
  •   561/14(FF-MC) , Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   2014-003746-27 
  •   NCT02503293  (Clinical Trials.gov)
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Health Condition or Problem studied

  •   Primary immunodeficiency syndrome -10064859
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Interventions/Observational Groups

  •   subcutaneous injections of Gammanorm 165 mg/ml for 3 months starting with syringe and followed by 3 months Gammanorm s.c. application using a pump.
  •   subcutaneous injections of Gammanorm 165 mg/ml for 3 months starting with pump and followed by 3 months Gammanorm s.c. application using a syringe.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Crossover
  •   III
  •   Yes
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Primary Outcome

To compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL by delivery device used. Assessment will be done using the "Life Quality Index" (LQI) score (factor 1: treatment interference) at the end of each 3 month treatment period.

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Secondary Outcome

To compare the other quality of life scores. Assessment will be done using the "Life Quality Index" (LQI) score (factor 2: therapy related Problems; factor 3: therapy setting) at the end of each 3 month treatment period.

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Countries of Recruitment

  •   Germany
  •   United Kingdom
  •   Italy
  •   Australia
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/07/29
  •   40
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

•Adult patients (≥ 18 years).
•Presenting with primary immunodeficiency.
•Having received subcutaneous injections of immunoglobulin at home using an automatic pump or syringe for at least 1 month at the time of inclusion.
•For whom the investigator decides to maintain immunoglobulin replacement therapy with subcutaneous injections of Gammanorm® 165 mg/mL at home.
•Freely given written informed consent from patient.
•Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study

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Exclusion Criteria

•Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.

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Addresses

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    • Octapharma Pharmazeutika Prod.Ges.m.b.H. | Octapharma Pharmazeutika Prod.Ges.m.b.H | A-1100 Vienna Austria |
    • Oberlaaer Strasse 235
    • 1100  Wien
    • Austria
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    • Octapharma Pharmazeutika Prod.Ges.m.b.H.
    • Ms.  Dr.  Tatiana  Lavrova 
    • Oberlaaer Strasse 235
    • 1100  Wien
    • Austria
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    • Octapharma Pharmazeutika Prod.Ges.m.b.H.
    • Ms.  Dr.  Tatiana  Lavrova 
    • Oberlaaer Straße 235
    • 1100  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Octapharma Pharmazeutika Prod.Ges.m.b.H.
    • Oberlaaer Straße 235
    • 1100  Wien
    • Austria
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/11
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Trial Publications, Results and other Documents

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