EUCTR2013-004842-40-ES进行中（未招募）1 期
Pilot study to evaluate the effect of plasma exchange in motor and cognitive function in patients with amyotrophic lateral sclerosis - Albumin in ALS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •In order to be eligible for participation in the trial, the patients must meet the following requirements:
- •- Must give written informed consent.
- •- Age ?18 and <70 years.
- •- Subjects with diagnosis of definitive, posible and probable ALS according El Escorial-Arlie criteria.
- •- Subjects with ALS symptom onset < 18 months from recruitment.
- •- FVC > 70%.
- •- Be medically able to undergo study procedures and to comply with the visits schedule at the time of inclusion in the study.
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria will not be able to participate in the trial:
- •- Subjects with a clinically significant preexisting lung disease not attributable to ALS.
- •- Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS.
- •- Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study.
- •- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
- •- Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol
- •- Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team (Banc de Sang i Teixits, BST Bellvitge).
- •- A history of frequent adverse reactions (serious or otherwise) to blood products.
- •- Hypersensitivity to albumin or allergies to any of the components of Albutein®.
- •- Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoaguants
- •- Plasma creatinine > 2mg/dl.
- •- Present a history of heart disease including ischemic heart disease or congestive heart failure.
- •- Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment
- •- Any condition that complicates adherence to study protocol (illness with less than one year of expected survival , drug or alcohol abuse, etc.)
研究者
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