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 Le
Conditions
Interventions
Trade Name: PROCICLIDE
Product Name: Defibrotide
Product Code: Defibrotide
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
CRINOS S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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subjects who receive concomitant fibrinolytic drugs and/or platelet aggregation inhibitors, ASA, NSAIDS, that cannot be withdrawn without prejudice to the health, subjects that receive veno-active drugs (e.g.: diosmine, rutosides), subjects presentingwith congestive hearth failure (NYHA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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Time to first episode of recurrence of DVT, objectively confirmed, during treatment, in comparison with placebo group.;Main Objective: To assess whether oral defibrotide treatment may offer a 50% increase in the protection against the recurrenceof DVT, and further confirm its safety in long term administration.;Secondary Objective: To assess the effect of oral defibrotide treatment on other thrombo-embolic events, venous and arterial, and VTE related cardiovascular mortality, objectively assessed, during treatment, in comparison with placebo. To evaluate the changes in in the patient´s assessment of the Quality of Life, and to confirm the long term safety of oral defibrotide treatment. To evaluate the acceptance of treatment both by the patient and by the investigator. | — |
Countries
Czech Republic
Outcome results
None listed