EUCTR2013-005557-73-GB进行中（未招募）1 期
An international, multicentre, efficacy and safety study of I10E in initial and maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy - PRISM
FB BIOTECHNOLOGIES0 个研究点目标入组 42 人开始时间: 2014年8月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
入选标准
- •1. Male or female patient aged 18 years or more.
- •2. - Definite or probable CIDP according to the European Federation of Neurological Societies (EFNS)/Peripheral Nerve Society (PNS) guidelines 2010 clinical and neurophysiological criteria.
- •- Pure motor CIDP, provided that a diagnosis of multifocal motor neuropathy has been ruled out.
- •- CIDP associated with monoclonal gammopathy of undetermined significance (MGUS), provided that anti-MAG antibodies titer is lower than the used technique's negativity threshold (1000 BTU for Bühlmann ELISA technique).
- •- Lewis-Sumner syndrome.
- •3. Score of at least 2 on the adjusted INCAT disability scale.
- •4. Patient who either :
- •a) has never been previously treated with Ig (Ig-naive patient)
- •b) was previously treated with Ig but is in clinical relapse following treatment withdrawal. In the latter case, the last Ig course shall have been administered no less than 3 months prior to screening.
- •5. Covered by national healthcare insurance system as required by local regulations.
- •6. Written informed consent obtained prior to any study-related 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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. History of severe allergic reaction or serious adverse reaction to any immunoglobulin (Ig).
- •2. Clinically documented lack of response to previous Ig treatment.
- •3. History of IgA deficiency (IgA = 70 mg/L), unless the absence of anti-IgA antibodies has been documented.
- •4. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
- •5. History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled
- •hypertension.
- •6. History of venous thrombo-embolic disease, myocardial infarction or, cerebrovascular accident.
- •7. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematologic malignancy with monoclonal gammopathy.
- •8. History of personal or familial congenital thrombophilia or acquired thrombophilia.
- •9. Factors contributing to venous stasis such as long-term bed confinement.
- •10. Body mass Index (BMI) =40 kg/m².
- •11. Protein-losing enteropathy characterised by total serum protein levels <60 g/L and serum albumin levels <30 g/L or nephrotic syndrome characterised by proteinuria =3.5 g/24hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
- •12. History of kidney transplantation, nephrotic syndrome (defined as proteinuria > 3.5 g per 24 hours accompanied by hypoalbuminemia and edema), or any acute or chronic kidney disease that in the opinion of the investigator and/or nephrologist would preclude that the use of I10E and/or interfere with the assessment of the safety and efficacy of I10E.
- •*Chronic kidney disease (CKD) for more than 3 months as documented by at least one of the following:
- •*Glomerular filtration rate <60 mL/min/1.73m² measured according to the Modified Diet in Renal Disease (MDRD) formula
- •*urine protein reagent strip: = 2 crosses
- •*urine protein reagent strip: one cross with one of the following:
- •*albumin excretion rate (AER) > 300 mg/24 hours or protein excretion rate (PER) > 500 mg/24 hours (24h-urine collection)
- •*albumin to creatinine ration (ACR) >30mg/mmol or protein to creatinine ratio (PCR) > 50 mg/mmol (spot urine sample)
- •13. Serum levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times upper limit of normal (ULN) range.
- •14. Any other ongoing disease that may cause chronic peripheral neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective tissue diseases, infection with HIV, HBV or HCV, Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloid, and hereditary
- •neuropathy.
- •15. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception.
- •Effective contraceptive are injectables, patch or oral combinded o eston progestative or progestative contraceptives, Cooper T or levonorgest releasing intra-uterine devices, depot intramuscular medroxyprogest
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