EUCTR2009-017672-24-FI进行中（未招募）不适用
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
- 不适用
- 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: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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 (ie, 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).
- •Monoclonal gammopathy of uncertain significance (MGUS) associated with anti-MAG Immunoglobulin M (IgM) antibodies and subjects 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.
- •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) > 60 mg/dl,
- •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 (as defined in Section 4.3) 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
相似试验
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)Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)MedDRA version: 13.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-017672-24-BECSL Behring GmbH30
尚未招募
Unknown
A SINGLE ARM CLINICAL STUDY TO EVALUATE EFFICACY OF AGNIKARMA WITH GUDA IN PAIN MANAGEMENT OF JANUSANDHI SHOOLA W.S.R OSTEOARTHRITISCTRI/2023/07/054667Sane Guruji Rugnalaya Hadapsar pune
尚未招募
2 期
A clinical study to evaluate effectiveness of karanjadi lepa in dadru with special referance to bahihparimarjan chikista siddhant (when locally applied)CTRI/2023/08/057030Sane Guruji Arogya Kendra
已完成
2 期
Clinical study to see the effect of Khadir-saar possessed water in Diabetes Mellitus and related urinary disordersCTRI/2021/12/038761Dr Deeksha Katna30
招募中
4 期
Evaluation study of ferric carboxymaltose injection in hemodialysis patientsIron deficiency anemiaJPRN-jRCTs051230025Araki Shin-ichi30