E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Deep Vein Thrombosis related central vein catheter (DVT-CVC) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051055 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To asses the efficacy and safety of bemiparin in the prevention of deep vein thrombosis in cancer patients with central vein catheter (CVC) |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Males and females patients at least 18 years old; Cancer patients; Patients with current value of platelet > 30.000/mm3; Patients without bleeding symptomatology |
|
E.4 | Principal exclusion criteria |
Patients with previous bleeding episodes and / or high risk of blood loss (due to any change in haemostasis) and/or patients with active haemorrhage and organic lesions that are likely to bled within last two months; Major surgery within last month; Patients, with known hypersensitivity reactions to LWHs, heparin or any substances of porcine origin; Patients with congenital or acquired bleeding diathesis; Eye, ear and central nervous system damages or surgeries within the last 6 months; Acute bacterial endocarditis and slow endocarditis; Patients with history of heparin-induced thrombocytopenia; Patients with severe renal impairment (serum creatinine> 2 mg/dl) or severe impairment of liver (AST and/ or ALT levels more than five times the normal limit according to the locals laboratory ranges); Acute arterial hypertension (Systolic arterial hypertension> 200 mmHg and/ or diastolic arterial hypertension >120 mmHg); Suspected patients or patients unable to carry out the treatment or to follow up the study; Patients who have been enrolled in another clinical trial in the past 30 days, or patients who are currently enrolled in another CT; Life expectancy of less than three months; Pregnant or lactating women and women of child-bearing potential; Current anticoagulant therapy or anticoagulant treatment within the week prior to the CVC insertion; Diagnosed patients with acute leukaemia or patients who are going to undergo a haematopoietic progenitor transplantation during the 90 study´s days |
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E.5 End points |
E.5.1 | Primary end point(s) |
Composite incidence during the treatment period of: •Clinical and symptomatic Deep Vein Thrombosis related Central Vein Catheter checked by objective testing(Doppler ecography or flebography) •Subclinical or asymptomatic DVT-CVC confirmed by bilateral elective Doppler ecography in the day 45 ± 5 after the aleatorization. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |