A 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
Primary Immunodeficiency
About this trial
This is an interventional treatment trial for Primary Immunodeficiency
Eligibility Criteria
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.
Exclusion Criteria:
• Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
Sites / Locations
- CampbelltownHospital
- Canberra Hospital
- University Medical Centre Freiburg
- Municipal Hospital "St. Georg"
- Azienda Ospedaliera di Padova, Allergologia ed Immunologia Clinica
- Policlinic Umberto I - Universita di Roma "Sapienza", Clinical Immunology
- University Hospitals Birmingham
- University Hospital of Wales
- - The Royal London Hospital
- The Royal Free
- John Radcliff Hospital
- Derriford Hospital
Arms of the Study
Arm 1
Arm 2
Other
Other
Chrono Super PID then Generic Syringe - Gammanorm
Generic Syringe then Chrono Super PID - Gammanorm
Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Chrono Super PID then Generic Syringe-Gammanorm
Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design: • Generic Syringe then Chrono Super PID-Gammanorm