A Multicentre Phase III Study on the Efficacy, Safety and Pharmacokinetics of LFB-IgSC in Patients with Primary Immunodeficiency (PID) Syndromes

FB Biotechnologies0 个研究点目标入组 55 人开始时间: 2013年8月5日最近更新: 2015年12月7日

适应症

试验速览

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•- Male or female aged from 2 to 70 years old
•- Primary immunodeficiency syndrome with predominant antibody deficiency as: X-linked agammaglobulinaemia (XLA), Common variable immunodeficiency (CVID), Other PID syndrome in which the main immunological defect is deficiency in IgG production.
•- Stable IgG therapy for at least 5 months before the study, with a constant dose ranging from 0.2 to 0.8 g/kg per month and with regular intervals of 3 to 4 weeks for IVIg and one week for SCIg.
•- At least 2 documented serum IgG trough levels = 5 g/l with the previous IgG dosage regimen.
•- For women of childbearing potential, negative blood pregnancy test at enrolment and agreement to use a medically-acceptable method of contraception throughout the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 25
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- History of severe allergy or serious adverse reaction to any IVIg, SCIg or an excipient of LFB-IgSC.
•- Patient with known antibodies to IgA.
•- Glomerular filtration rate < 80 ml/min/1.73m2 measured according to the Modified Diet in Renal Disease (MDRD) calculation.
•- Progressive hepatic disease that could worsen during the study.
•- Refusal of PK study (for adults only).
•- History of cardiac ischemia, cardiac insufficiency, cerebral ischemia, stroke, thrombotic events or pulmonary embolism.
•- Any additional cause of immunodeficiency, other than a primary immunodeficiency, (such as acquired immunodeficiency or malignancy of lymphoid cells).
•- Allogenic haematopoietic stem cell transplantation.
•- Need for routine premedication before SCIg infusions (excluding dermal anaesthetics).
•- Need for long-term therapy with corticosteroids or prophylactic antibiotics during the study.
•- Immunosuppressive agents, including anti-CD20 antibodies, during the last 6 months.

发起方

FB Biotechnologies