Gammanorm Quality of Life Study in Immunodeficient Patients Using Rapid Push or Pumps
- Conditions
- Primary Immunodeficiency (PID)
- Interventions
- Biological: Gammanorm
- Registration Number
- NCT02180763
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- Patient currently participating in another interventional study at the time of inclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Gammanorm® 165 mg/mL Gammanorm -
- Primary Outcome Measures
Name Time Method "Life Quality Index" (LQI) score (factor I: treatment interference) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
University Hospital of Lille
🇫🇷Lille, France
Clinique Mutualiste
🇫🇷Lyon, France
University Hospital of Toulouse
🇫🇷Toulouse, France
Haut-Leveque Hospital
🇫🇷Bordeaux, France
Hospital Dupuytren
🇫🇷Limoges, France
University Hospital of Caen
🇫🇷Caen, France
University Hospital of Reims
🇫🇷Reims, France
University Hospital of Tours
🇫🇷Tours, France