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

Launched by OCTAPHARMA · Jul 17, 2015

Keywords

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Gender

ALL

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.