EUCTR2008-007016-15-IT进行中（未招募）不适用
RANDOMISED STUDY OF FIRST CHOICE IMMUNOTOLERANCE INDUCTION IN PATIENTS WITH SEVERE TYPE A HAEMOPHILIA WITH INHIBITOR AT HIGH RISK OF FAILURE: COMPARISON OF INDUCTION OF IMMUNE TOLERANCE WITH FVIII CONCENTRATES WITH OR WITHOUT VON WILLEBRAND FACTOR - RES.I.ST.NAÏVE
FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI0 个研究点目标入组 148 人开始时间: 2009年3月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
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
- Male
入选标准
- •a. severe hemophilia A (FVIII<1%) b. male patients, any age; c. high responders (peak inhibitor levels > 5 BU); d. any inhibitor level at study enrolment; e. ability and willingness to participate in to the study; f. no concomitant systemic treatment with drugs with immunosuppressive side effects (eg. Corticosteroids, if used more than 5 days every iii months and/or at a dose of > 2mg/kg or 60 mg/day), azathioprine, cyclophosphamide, high?dose immunoglobulin as well as the use of a protein A column or plasmapheresis, interferons); g. no concomitant experimental treatment; h. at least one of the following risk factors for ITI failure: i. peak inhibitor titer > 200 BU ii. titer at ITI start > 10 BU iii. age > 7 years iv. time between inhibitor occurrence and ITI > 2 years i. no previous ITI attempt.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •see inclusion criteria
研究者
相似试验
进行中（未招募）
不适用
RANDOMISED STUDY OF FIRST CHOICE IMMUNOTOLERANCE INDUCTION IN PATIENTS WITH SEVERE TYPE A HAEMOPHILIA WITH INHIBITOR AT HIGH RISK OF FAILURE: COMPARISON OF INDUCTION OF IMMUNE TOLERANCE WITH FVIII CONCENTRATES WITH OR WITHOUT VON WILLEBRAND FACTOR?Estudio randomizado que consiste en administrar por primera vez un tratamiento de inducción de inmunotolerancia en pacientes con hemofilia a grave con inhibidor y alto riesgo de fracaso: comparación de inducción de inmunotolerancia con concentrados de FVIII con o sin factor Von Willebrand?EUCTR2008-007016-15-ESFONDAZIONE CHARTA148
进行中（未招募）
1 期
Randomised Study of First Time Immunotolerance Induction in Patients with Severe Type A Haemophilia with Inhibitor at High Risk of Failure: Comparison of Induction of Immune Tolerance with FVIII Concentrates with or without Von Willebrand FactorPatients with severe Haemophilia A with a high responding inhibitor (more than 5 BU/ml)EUCTR2008-007016-15-GBniversity of Milan148
进行中（未招募）
不适用
Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207EUCTR2008-000417-30-ITG.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
进行中（未招募）
1 期
A study on the anti-inflammatory effects of azithromycin in tuberculosisPulmonary tuberculosisEUCTR2017-001929-40-NLniversity Medical Center Groningen24
招募中
2 期
A prospective, randomized pilot study of the immunomodulatory effects of azithromycin in adults with pulmonary tuberculosisTBTuberculosisNL-OMON47928niversitair Medisch Centrum Groningen24