EUCTR2009-017672-24-BE进行中（未招募）1 期
A single-arm study to demonstrate the efficacy and safety of Privigen in the treatment of subjects with chronic inflammatory demyelinating polyneuropathy (CIDP)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects meeting all of the following inclusion criteria may be enrolled into the study:
- •IVIG-untreated subjects: either subjects with newly diagnosed CIDP (developing
- •over at least 2 months) or subjects with an IVIG treatment interruption for at least 1
- •year with a progressive disease (deteriorating in the last 2 months) prior to
- •IVIG-pretreated subjects being treated regularly with IVIG:
- •- on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months
- •- on a fixed dosage of ± 20 % in the last 6 months
- •- deteriorating by at least 1 INCAT score point during the Washout Period of up to 10
- •weeks (except for an increase from 0 to 1 solely due to upper limb score).
- •Diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory
- •or symmetric motor nerve only in at least 1 limb resulting from neuropathy. Criteria
- •for definite or probable CIDP according to EFNS/PNS guideline.
- •- IVIG-untreated subjects need an actual diagnosis including electrophysiology.
- •- IVIG-pretreated subjects need a historic diagnosis.
- •Age =18 years.
- •Male or female.
- •Written informed consent for study participation obtained before undergoing any
- •study specific procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects meeting any of the following exclusion criteria must not be enrolled into the study:
- •A motor syndrome that fulfils criteria for multifocal motor neuropathy (MMN) with
- •conduction block (i.e., upper limb motor weakness without sensory deficit and with a
- •50% decrease in action potential amplitude or area on proximal compared with distal
- •stimulation in motor nerves).
- •CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-
- •MGUS antibodies and patients with distal acquired demyelinating symmetric (DADS)
- •neuropathy.
- •Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or
- •may interfere with treatment or outcome assessments with the INCAT (e.g.,
- •diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the
- •neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with
- •radicolopathy, post-polio-syndrome, M. Parkinson, stroke).
- •Current malignancy.
- •History of cardiac insufficiency (New York Heart Association [NYHA] III/IV),
- •cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or
- •advanced ischemic heart disease, congestive heart failure or severe hypertension.
- •History of thrombotic episodes (deep vein thrombosis, myocardial infarction,
- •cerebrovascular accident).
- •Migraine associated with IVIG infusion in the last 3 months prior to enrolment.
- •Known allergic or other severe reactions to blood products including intolerability to
- •previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis).
- •Subjects with serum IgA level less than 50% of the lower normal limit.
- •Known hyperprolinemia.
- •Any condition (including alcohol, drug or medication abuse) that is likely to interfere
- •with evaluation of the study product or satisfactory conduct of the study.
- •Plasma exchange 3 months prior to enrolment.
- •Treatment with immunomodulatory agents others than steroids, methotrexate or
- •azathioprine (e.g. interferon, TNF-a inhibitors) within 6 months before enrolment.
- •Treatment with rituximab in the 12 months before enrolment.
- •Abnormal laboratory parameters: creatinine > 1.5 times the upper normal limit (UNL),
- •lactate dehydrogenase (LDH) > 1.5 times the UNL, C-reactive protein (CRP) > 1.5
- •times the UNL, hemoglobin (Hb) < 10 g/dL.
- •Ongoing HIV, hepatitis C and hepatitis B infection.
- •Participation in another clinical study (or use of another investigational medicinal
- •product [IMP]) within 3 months prior to enrolment.
- •Not able to comply with study procedures and treatment regimen.
- •Employee at the study site, or spouse/partner or relative of any study staff (e.g.,
- •investigator, sub-investigators, or study nurse).
- •Pregnancy or nursing mother.
- •Intention to become pregnant during the course of the study.
- •Female subjects of childbearing potential either not using, or not willing to use, a
- •medically reliable method of contraception for the entire
- •duration of the study, or not sexually abstinent for the entire duration of the study,
- •or not surgically sterile.
研究者
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