Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT02503293
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02503293
Study Brief:
Protocol Section:
NCT02503293