E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic venous insufficiency |
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E.1.1.1 | Medical condition in easily understood language |
chronic venous insufficiency |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066682 |
E.1.2 | Term | Chronic venous insufficiency |
E.1.2 | System Organ Class | 100000004866 |
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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 |
The primary objectives of the study is to determine, in patients with symptoms of CVI, the effect of the administration of sulodexide on the concentration of inflammation parameters, endothelial indicators, glycocalyx and fibrinolysis indicators, as well as the effect of the impact of the collected serum on human umbilical vein endothelial cells (HUVEC). |
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E.2.2 | Secondary objectives of the trial |
The secondary endpoint of the study is to assess the morphological changes in the glycocalyx, visible with an optical and an electron microscope. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The study will include patients, irrespective of gender or race that meet all of the following criteria that occur jointly:
Adult patients over 18 years up to 75 years inclusive
Symptoms of CVI in the medical history
CVI signs found during the screening visit based on the CEAP classification for parameter C in the range C2-C4
Insufficiency of the GSV trunk in both legs found during the Duplex Doppler ultrasound performed during the screening visit
Eligible for EVLA GSV treatment in the thigh and upper 1/3 of the calf in both legs over two consecutive treatments
Having independent legal capacity and the ability to sign informed consent to participate in the study |
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E.4 | Principal exclusion criteria |
The study will not include patients in whom there is a finding of at least one of the following factors:
An episode of symptomatic venous thromboembolism in the form of superficial or deep vein thrombosis in the arms or legs, splanchnic vein thrombosis or pulmonary embolism of any clinical severity, confirmed clinically or on imaging studies, if pharmacological treatment of this disease has been completed less than 6 months from the date of the screening/operative visit; pharmacological treatment is taken to mean treatment of the acute phase of venous thromboembolism and secondary prevention
Diabetes
Lupus
Scleroderma
Any other diseases of known and proven autoimmune aetiology
Absolute contraindications for GSV EVLA treatment in one or both legs;
Any relative or absolute contraindications to the administration of sulodexide or any other substance that is a component of the capsule of the administered drug Vessel Due F
Any relative or absolute contraindications to the administration of enoxaparin or any other substance that is a component of prefilled syringes of this substance and simultaneously any relative or absolute contraindications to the administration of nadroparin or any other substance that is a component of prefilled syringes of this substance and simultaneously any relative or absolute contraindications to the administration of dalteparin or any other substance that is a component of prefilled syringes of this substance
The use of inotropic agents less than 10 days from the day of the screening/operation visit
The use of statin drugs
The use of any drug which is an absolute contraindication to the use of sulodexide or low molecular weight heparin
Taking sulodexide less than three months from the date of the screening/operation visit
Participation in another clinical study, less than four weeks from the day of the screening/operation visit
Pregnancy and the post-partum period up to 6 months after birth
Breast-feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
V2 and V5 (day 0 and day 76 to 110) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
V2 and V5 (day 0 and day 76 to 110) |
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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 | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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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 | 0 |