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
- Conditions
- MedDRA - Primary immunodeficiency syndrome -10064859
- Registration Number
- DRKS00008784
- Lead Sponsor
- Octapharma Pharmazeutika Prod.Ges.m.b.H. | Octapharma Pharmazeutika Prod.Ges.m.b.H | A-1100 Vienna Austria |
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
•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
•Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.