Defibrotide in the prevention of recurrences in venous thrombosis: DEPRIVE.A randomised, multicentre, European, double blind, parallel group study, to assess the efficacy and tolerability of defibrotide versus placebo in the prevention of recurrences in venous thromboembolism - DEPRIVE

CRINOS S.p.A.0 个研究点目标入组 810 人开始时间: 2006年1月27日最近更新: 2012年3月19日

试验速览

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•Adult male or female outpatients, age 18-75 years. Have suffered from a documented recent episode of DVT (within 1 year of the screening visit),
•irrespective whether the DVT episode was provoked or non provoked, first episode or recurrence, OAT must be ended since 30 days on the date of the screening visit.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients who still present signs of active DVT at color flow Doppler scanning, Female patients in child bearing age not using adequate contraceptive method, or using oral hormonal contraception, obesity as defined by a Body Mass Index (BMI) 32 kg/m2 (see appendix 28.5), severe alteration of coagulation parameters, clinically relevant kidney function impairment (serum creatinine exceeding 150% of the upper normal range), clinically relevant impairment of liver function (serum enzymes and/or bilirubin exceeding 150% of the upper normal range), subjects who receive concomitant fibrinolytic drugs and/or platelet aggregation inhibitors, ASA, NSAIDS, that cannot be withdrawn without prejudice to the health, subjects that receive veno-active drugs (e.g.: diosmine, rutosides), subjects presentingwith congestive hearth failure (NYHA clas III and IV), (see appendix 28.6). Patients suffering from peripheral obstructive arterial disease.

发起方

CRINOS S.p.A.