EUCTR2013-005558-31-IT进行中（未招募）1 期
International, multicentre, efficacy and safety study of I10E in the maintenance treatment of patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: Extension of PRISM studyI10E-1302 - PRISM 2
FB BIOTECHNOLOGIES0 个研究点目标入组 30 人开始时间: 2015年5月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •. Male or female patient aged 18 years or more.
- •2. Responder patient who have completed the last visit of PRISM I10E-
- •1302 study defined as a patient with a decrease =1 point in the adjusted INCAT disability score between baseline and the end-of-study (EOS) visit of PRISM I10E-1302 study.
- •3. Covered by national healthcare insurance system as required by local regulations.
- •4. 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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Based on follow-up and results of analyses performed in PRISM I10E-1302 study, a patient may be eligible in PRISM 2 I10E-1306 study if none of the following criteria is met:
- •1. History of severe allergic reaction or serious adverse reaction to any Ig.
- •2. Known hypersensitivity to human Ig or to any of the excipients of I10E (glycine and polysorbate 80).
- •3. History of cardiac insufficiency (New York Heart Association (NYHA) III/IV), uncontrolled cardiac arrhythmia, unstable ischemic heart disease, or uncontrolled hypertension.
- •4. History of venous thromboembolic disease, myocardial infarction or cerebrovascular accident.
- •5. Risk factor for blood hyperviscosity such as cryoglobulinemia or haematological malignancy with monoclonal gammopathy.
- •6. History of personal or familial congenital thrombophilia or acquired thrombophilia.
- •7. Factors contributing to venous stasis such as long-term bed confinement.
- •8. Body mass index (BMI) =40 kg/m².
- •9. Protein-losing enteropathy characterised by serum protein levels <60 g/L and serum albumin levels <30 g/L or nephrotic syndrome characterised by proteinuria =3.5 g/24 hours, serum protein levels <60 g/L and serum albumin levels <30 g/L.
- •10. Glomerular filtration rate <80 mL/min/1.73m² measured according to the Modified Diet Renal Disease (MDRD) calculation.
- •11. Serum levels of Alanine aminotransferase (AST) or Aspartate aminotransferase (ALT) >2 times upper limit of normal range.
- •12. 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, Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinaemia, amyloidosis, and hereditary neuropathy 13. Woman with positive results on a urine pregnancy test or
- •breastfeeding woman or woman of childbearing potential without an effective contraception. Effective contraceptives are injectable, patch or combined oestro-progestative or progestative contraceptives, Copper T or levonorgest releasing intra-uterine devices, depot intramuscular medroxyprogesterone, subcutaneous progestative contraceptive implants, condoms or occlusive caps (diaphragm or
- •cervical/vault caps) with spermicide, true abstinence (when this is in line with the preferred and usual lifestyle of the patient).
研究者
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