EUCTR2010-024423-24-IT进行中（未招募）1 期
Studio prospettico, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, di fase 2/3 sull'efficacia e la sicurezza di masitinib a confronto con placebo nel trattamento di pazienti affetti da Sclerosi Laterale Amiotrofica (SLA) - AB10015
AB SCIENCE0 个研究点目标入组 394 人开始时间: 2014年2月4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
- 394
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
- •1. Female or male patient aged between 18 and 75 years of age, with a weight > 50 kg and BMI between 18 and 35 kg/m².
- •2. Familial or sporadic ALS
- •3. Patient diagnosed with laboratory supported, clinically probable or definite ALS according to the World Federation of Neurology Revised El
- •Escorial criteria (Brooks, 1994)
- •4. Disease duration from symptoms onset no longer than 36 months at the screening visit
- •5. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening
- •6. Patient with a FVC (Forced Vital Capacity) equal to or more than 60% predicted normal value for gender, height, and age at the screening visit
- •7. Patient with life expectancy = 6 months
- •8. Patient with adequate organ function at screening and baseline:
- •Absolute Neutrophils Count (ANC) = 2 x 109/L
- •Hemoglobin = 10 g/dL
- •Platelets (PTL) = 100 x 109/L
- •AST/ALT = 3 ULN
- •Bilirubin = 1.5 ULN
- •Albuminemia > 1 x LLN
- •Creatinine clearance > 60 mL/min (Cockcroft and Gault formula)
- •Proteinuria < 30 mg/dL (1+) on dipstick; in case of the proteinuria = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
- •9. Male patient or female patient of child bearing potential, who must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception (with failure rate < 1%) during the study and for three months after the last treatment intake
- •10. Female patient of childbearing potential must have a negative pregnancy test at screening and baseline
- •11. Patient able and willing to comply with study procedures as per protocol
- •12. Patient able to understand, and willing to sign, and date the written informed consent form at screening visit prior to any protocol-specific
- •13. Patient able to understand, and willing to follow the safety procedures mentioned on the patient card in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first two months of treatment
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •1. Patient with history of hematologic, hepatic, respiratory disorder that is clinically significant for his/her participation in the study
- •2. Patient who underwent tracheotomy and /or gastrostomy
- •3. Patient with a diagnosis of cancer or evidence of continued disease within five years before starting study treatment
- •4. Patient with significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical illness and psychiatric
- •5. Patient who have participated in a clinical trial within 3 months prior to screening
- •6. Pregnant, or nursing female patient
- •7. Patient with a known diagnosis of human immunodeficiency virus
- •(HIV) infection
- •8. Patient with known hepatitis B, hepatitis C or tuberculosis
- •9. Patient with any severe and/or uncontrolled medical condition
- •10. Patient having cardiac disorders defined by at least one of the following conditions:
- •Patient with recent cardiac history (within 6 months) of:
- •- Acute coronary syndrome
- •- Acute heart failure (class III or IV of the NYHA classification)
- •- Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •Patient with cardiac failure class III or IV of the NYHA classification
- •Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •Syncope without known aetiology within 3 months
- •Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
- •11. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
- •PREVIOUS TREATMENTS WASH OUT
- •12. Patient treated with any investigational agent within 3 months prior to screening
研究者
相似试验
进行中（未招募）
1 期
Etude prospective, multicentrique, randomisée, en double-aveugle, contrôlée à groupes parallèles, visant à évaluer la balance bénéfice-risque du sevrage progressif d'un inhibiteur de la calcineurine (Tacrolimus) chez des patients transplantés depuis plus de 4 ans et cliniquement sélectionnés - Arrêt du Tacrolimus en transplantation rénaleTransplantation rénaleEUCTR2010-019574-33-FRCHU de Nantes
进行中（未招募）
不适用
Etude prospective, multicentrique, randomisée, en ouvert, évaluant la progression de la fibrose rénale selon le profil de transition épithélio-mésenchymateuse chez des patients adultes transplantés rénaux de novo traités par une immunosuppression sans inhibiteur de la calcineurine associant Certican® et Myfortic® versus une immunosuppression standard associant Néoral® et Myfortic® (Etude CERTITEM). - CERTITEMEUCTR2009-011473-33-FRovartis Pharma S.A.S.
进行中（未招募）
不适用
Estudio prospectivo, multicéntrico, aleatorizado, comparativo, doble ciego, para evaluar dos emulsiones lipídicas diferentes en la nutrición parenteral total del enfermo crítico y su influencia en la infección nosocomial.Prospective study, multicentric, randomized, comparative, double blind, to evaluate two different lipidic emultions in the total parenteral nutrition of the critic ill and their influence in the nosocomial infection. - ICULIPEUCTR2005-003542-33-ESB Braun Medical S.A.212
进行中（未招募）
不适用
Estudio prospectivo, multicéntrico, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos, para evaluar la eficacia y seguridad de clazosentan en la reducción de la morbilidad relacionada con el vasoespasmo, así como de la mortalidad por cualquier causa, en adultos con hemorragia subaracnoidea aneurismática tratados con coiling endovascular - CONSCIOUS 3Indicación: Hemorragia Subaracnoidea AneurismáticaMedDRA version: 11Level: LLTClassification code 10042316Term: <Manually entered code. Term in E.1.1>EUCTR2008-006785-29-ESActelion Pharmaceuticals Ltd.1,470
进行中（未招募）
1 期
Estudio multicéntrico, prospectivo, aleatorizado, doble ciego, de doble simulación, controlado con activo y con placebo, para evaluar la eficacia y la seguridad de la combinación BAY 60-4552 / vardenafilo, comparada con vardenafilo (20 mg) en el tratamiento de la disfunción eréctil que no responde adecuadamente a la terapia habitual con inhibidores de PDE5EUCTR2010-020122-18-ESBayer HealthCare AG