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Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02180763
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Octapharma

Brief Summary:
The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.

Condition or disease Intervention/treatment Phase
Primary Immunodeficiency (PID) Biological: Gammanorm Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.
Study Start Date : April 2014
Actual Primary Completion Date : August 28, 2016
Actual Study Completion Date : August 26, 2017


Arm Intervention/treatment
Experimental: Gammanorm® 165 mg/mL Biological: Gammanorm
Sub-Q IgG




Primary Outcome Measures :
  1. "Life Quality Index" (LQI) score (factor I: treatment interference) [ Time Frame: 6 Months ]
    Primary endpoint for assessment of patient's satisfaction regarding the treatment delivery device (pump or syringe) will be the "Life Quality Index" (LQI) score (factor I: treatment interference) at the end of each 3-month treatment period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (≥ 18 years)
  • Presenting with primary immunodeficiency
  • Having received subcutaneous injections of immunoglobulin at home using an automatic pump 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
  • Having signed an informed consent form

Exclusion Criteria:

  • Patient currently participating in another interventional study at the time of inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180763


Locations
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France
Haut-Leveque Hospital
Bordeaux, France
University Hospital of Caen
Caen, France
University Hospital of Lille
Lille, France
Hospital Dupuytren
Limoges, France
Clinique Mutualiste
Lyon, France
University Hospital of Reims
Reims, France
University Hospital of Toulouse
Toulouse, France
University Hospital of Tours
Tours, France
Sponsors and Collaborators
Octapharma
Investigators
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Principal Investigator: Boris Bienvenu, MD Universtiy Hospital of Caen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT02180763    
Other Study ID Numbers: GAN-03
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Keywords provided by Octapharma:
Primary Immunodeficiency, PID
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases