Assessment of the IgG trough level in subjects with primary immunodeficiency switching from standard subcutaneous immunoglobulin (SCIG) to every other week HyQvia - HyQvia

Centre Hospitalier Régional et Universitaire de Lille0 个研究点目标入组 22 人开始时间: 2016年11月22日最近更新: 2019年6月30日

适应症

试验速览

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•To be included, subjects must satisfy all the following 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.
•For patients who don’t want to participate in the study, the reason of their refusal will be collected if they agree to.
•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 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•Subjects satisfying one or more of the following criteria should not take part in the study:
•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.

发起方

Centre Hospitalier Régional et Universitaire de Lille