EUCTR2006-001383-23-IT进行中（未招募）1 期
Efficacy, safety and pharmaco-economic assessment of secondary long term prophylaxis with highly purified, standardized, doubly virus inactivated FVIII/VWF concentrates in patients with severe, inherited VWD and frequent bleedings - PRO.WI
FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI0 个研究点目标入组 24 人开始时间: 2006年11月28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
- 24
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
- •- Documented unresponsiveness to DDAVP. All the patients, excluding type 3 and type 2B, should have been exposed to a documented infusion trial with DDAVP. Responsiveness to DDAVP is defined as an increase in plasma FVIII C and VWF RCo levels of at least three fold over baseline and in absolute reaching at least 30 IU/dl for both values and a BT of 12 minutes or less after 2 hours from administration of 0,3 mcg/kg of DDAVP OR contraindication to DDAVP namely type 2B VWD patients or other patients who display significant side effects to DDAVP - Frequent, spontaneous bleedings i.e. at least 5 episodes in whatever anatomical site in the last 12 months, severe enough to require treatment with FVIII/VWF concentrates Note that prolonged or excess bleeding during menses is not considered among inclusion criteria in this study OR Recurrent spontaneous bleedings, severe enough to require treatment with FVIII/VWF concentrates of the following types 61607; Epistaxes at least 5 episodes in the last 12 months 61607; Haemarthroses at least 3 episodes at the same joint in the last 12 months 61607; Gastrointestinal bleeding at least 2 episodes in the last 12 months, with a drop 61619; 2 g/dl of haemoglobin in 24-48 hours due to unexplained reason or in association with underlying gastrointestinal angiodysplasia - Willingness to participate in the study, expressed by signed, written informed consent
- •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
- •- a life expectancy 1 year - presence of allo-antibodies to VWF or FVIII - acquired Von Willebrand syndrome AVWS - co-morbidity with other haemorrhagic diathesis, excluded those linked to VWD as the complication of treatment for instance thrombocytopenia in Type 2B VWD - advanced liver cirrhosis with 61607; cirrhosis related coagulation abnormalities thrombocytopenia, defined as platelet count 50.000/mm3, INR 1,7, prolonged prothrombin time 4 seconds versus normal 61607; portal hypertension with history of variceal bleeding - pregnancy and lactation - any known need for invasive procedures or elective surgery scheduled in the following 3 months recruitment in these cases should be postponed - proven co-morbidity for other causes of gastrointestinal bleeding not related to the studied disease as drug induced haemorrhagic gastropathy, upper GI tract ulcers or cancer, or operable conditions, e.g. haemorrhoids with the exception of concomitant angiodysplasia which meets the inclusion criteria - gastrointestinal bleeding due to trauma, invasive diagnostic or surgical procedures - concomitant autoimmune anaemia and/or autoimmune thrombocytopenia
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