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 an infusion pump or syringe
- Conditions
- immunodeficiency syndromeMedDRA version: 19.1Level: HLTClassification code 10036700Term: Primary immunodeficiency syndromesSystem Organ Class: 100000004870Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2014-003746-27-DE
- Lead Sponsor
- Octapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Strasse 235, A-1100 Vienna, Austria
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
•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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
•Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare patient satisfaction score;Secondary Objective: additional life quality scores;Primary end point(s): patient satisfaction score ;Timepoint(s) of evaluation of this end point: see protocol
- Secondary Outcome Measures
Name Time Method Secondary end point(s): additional life quality scores;Timepoint(s) of evaluation of this end point: see protocol