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

Conditions: DVT and PE are part of the same disease that can be defined Venous Thromboembolism (VTE). Treatment of the acute phases is well established: LMWH during the first days and OAT for 3-12 months. After cessation of OAT, recurrence venous thromboembolism (VTE) often occurs, with an estimated early rate of 6-9%. Defibrotide possesses antithrombotic, anti-ischemic and thrombolytic properties, without anti-coagulant effects. Defibrotide after cessation of OAT could reduce the recurrence rate of VTE
Level: PTClassification code 10051055

Registration Number: EUCTR2005-005524-13-CZ

Lead Sponsor: CRINOS S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 810

Inclusion Criteria

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

Exclusion Criteria

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subjects who receive concomitant fibrinolytic drugs and/or platelet aggregation inhibitors, ASA, NSAIDS, that cannot be withdrawn without prejudice to the health, subjects that receive veno-active drugs (e.g.: diosmine, rutosides), subjects presentingwith congestive hearth failure (NYHA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.