IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia
Primary Immunodeficiency
About this trial
This is an interventional treatment trial for Primary Immunodeficiency focused on measuring Primary Immunodeficiency, SubCutaneous Immunoglobulins
Eligibility Criteria
Inclusion Criteria:
- Male or female subject at least 18 years old at the time inclusion.
- Suffering from PI requiring immunoglobulin replacement therapy.
- Treated with SCIG at stable dose for at least 3 months at the time of inclusion.
- Well balanced SCIG treatment according to the investigator at the time of inclusion.
- If female of childbearing potential, the subject must have a negative blood or urine pregnancy test at the time of inclusion and must agree to employ adequate birth control measures during the whole study.
- Willing and able to comply with the requirements of the protocol.
- Having signed the informed consent form.
Exclusion Criteria:
- Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 mL/min/1.73m2 estimated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the time of screening.
- Having received a chemotherapy or immunomodulating therapy for either malignant or chronic inflammatory disease for over 6 months.
- Receiving anticoagulant therapy.
- Having abnormal protein loss (protein losing enteropathy, nephrotic syndrome).
- Know allergy to hyaluronidase.
- Family member or employee of the investigator.
- Having participated in another interventional clinical study involving an investigational product (IP) or investigational device within 30 days prior to inclusion or scheduled to participate in another clinical study involving an another investigational product or investigational device during the course of this study.
- If female, pregnant or breastfeeding at the time of enrolment.
- If female, planning to become pregnant during the time period of the study.
Sites / Locations
- CHRU, Hôpital Claude Huriez
- Hôpital de la Conception
- CHU de Nantes - Hôtel Dieu
- Hôpital St Louis
- Hôpital Necker
- Hôpital Haut Lévèque
- CHU de Strasbourg
Arms of the Study
Arm 1
Experimental
IgHy10 (HyQvia)
Open-label, one arm study conducted in France in subjects with PI to IgG trough level at steady state after standard SCIG dosing and after IgHy10 (HyQvia) administered every other week and every 3-4 weeks at equivalent dose. The study will have three periods: The first period is a one-week ramp-up period. The first administration of IgHy10 (HyQvia) will be with a one-week dose During the first three-month follow-up period, IgHy10 (HyQvia) will be administered, every other week at a dose equivalent to the dose administered with the previous treatment (standard SCIG). At the end of this first follow-up period, the dose of IgHy10 (HyQvia) will be increased for the next infusion to reach a 3-4 week equivalent dose.