A comparative, double-blind, randomised, multicentre efficacy and safety study of ClairYg® versus Tégéline® in maintenance treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

FB BIOTECHNOLOGIES0 个研究点目标入组 40 人开始时间: 2012年9月3日最近更新: 2022年4月4日

适应症

试验速览

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•1.Male or female patient aged 18 years or more.
•2.Patient diagnosed as having CIDP by an experienced neurologist, after other causes of chronic neuropathy have been ruled out.
•3.Patient who meets the diagnosis criteria for definite or probable CIDP proposed by European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) 2010.
•4.Patient whose CIDP has already induced a disability, scored at least 2 on the Adjusted INCAT disability scale, even if this disability is controlled by the IVIG treatment at the time of the inclusion.
•5.Patient on maintenance treatment with IVIG, i.e., receiving IVIG since at least 6 months and for whom the minimal efficient treatment schedule has been ascertained.
•6.Patient for whom the current treatment schedule is within the following range:
•?Dose per course within 0.4 to 2 g/kg
•?Course frequency within every 2 to 8 weeks.
•7.If female and capable of bearing children, negative pregnancy test at enrollment and agreement to use adequate birth control measures for the duration of the study.
•8.Having signed a written informed consent prior to any study-related procedures.
•9.Covered by national healthcare insurance in accordance with French regulation.
•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 44
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.History of severe allergy or serious adverse reaction to any IVIG.
•2.Immunoglobulin A (IgA) deficiency with an IgA ponderal level <0.2g/l or known anti-IgA antibodies.
•3.Known hypersensitivity to any of the excipients of ClairYg® (mannitol, glycine and polysorbate 80) or Tégéline® (saccharose and sodium chloride).
•4.History of cerebral ischemia, cardiac ischemia, cardiac insufficiency, stroke, deep vein thrombosis or pulmonary embolism.
•5.Chronic renal insufficiency or serum creatinine level >120µmol/l.
•6.Use of loop diuretics (eg furosemide, bumetanide, piretanide).
•7.Progressive hepatic disease that could worsen during the study.
•8.Participation in another interventional clinical study within 3 weeks before inclusion (participation in an observational research program may be allowed provided that such program does not require the administration of a specific investigational medicinal product).
•9.Pregnant or breastfeeding woman or woman of childbearing potential with no adequate means of contraception.
•10.Any serious medical conditions that would prevent the patient from complying with the protocol requirements or interfere with the assessment criteria.

发起方

FB BIOTECHNOLOGIES