UnknownPhase 2

A Study to Evaluate Dimolegin in Prevention of Thromboembolic Complications During Knee Replacement

Russia240 participantsStarted 2019-05-31

Plain-language summary

This study is a multicenter, double-blind, randomized, prospective phase 2 dose ranging study to evaluate the safety and efficacy of Dimolegin - DD217 in prevention of venous thromboembolic complications in patients underwent knee replacement. The study model is at each stage in parallel groups. Dimolegin - DD217 efficacy and safety in prevention of venous thromboembolic complications during knee replacement in groups of 80 patients will be investigated. Patients who meet all inclusion criteria and none of the exclusion criteria will be randomized into three therapy groups: two therapy groups of the test drug Dimolegin - DD217 (40 mg (group 1a) and 60 mg (group 1b)) and one reference group (Fragmin). Bilateral phlebography (preferably) or ultrasound duplex scanning (USDS) will be performed on the Day of the V13 visit. It is planned to randomize 240 patients (160 patients in two different groups of Dimolegin - DD217 therapy and 80 patients in the reference group of Fragmin (INN: dalteparin). The number of patients included in the study and randomized to receive Dimolegin - DD217, at the first stage, can be increased in the case of starting recruitment to additional group 1b. The maximum number of patients who can be included in the study at the first stage is 320. In total, no more than 480 patients can take part in the screening. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be determined in patients who voluntarily give their consent to participate in the pharmacokinetic study (PKS) and pharmacodynamic study (PDS) and sign a Patient Information Leaflet with an informed consent form for participation in the PKS and PDS. PK parameters are planned to be determined in 18-20 patients (50 % of each sex) in each patient group. Participation in the voluntary part of PK study will be offered to all patients. The analysis of the composite endpoint frequency will be carried out using a generalized linear model for binary response. A formal conclusion about superiority will be made if the lower limit of the specified confidence intervals exceeds the value of 0.0. A formal conclusion on non-inferiority will be made if the lower limit of the specified confidence intervals exceeds the value of -0.05 (-5.0 %).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women aged 18 years and older who need elective primary total knee replacement (cement or cementless arthroplasty) * Signed informed consent * Ability to comply with all protocol requirements * Patients' consent to use adequate methods of contraception throughout the study Exclusion Criteria: * Surgery for an acute fracture 4 weeks before screening; septic inflammation of the joint, revision of the prosthesis or the absence of one leg * Venous thrombosis of any localization or a confirmed PE episode at the present time or in the medical history * Heparin-induced thrombocytopenia or other thrombocytopathies currently or in the history, hemorrhagic diathesis * Obvious coagulopathy ongoing or in the history of the patient or a blood relative * Congenital thrombophilia according to the medical history (deficiency of antithrombin III, protein C, protein S, Leiden mutation of coagulation factor V, increased level of coagulation factor VIII, mutation of prothrombin G20210A) * Active bleeding (intracranial, intraocular, nasal, digestive or other localization) at present or within 6 months prior to screening, high risk of bleeding * Collection of at least one volume unit of donated blood (\> 500 mL) or blood transfusion during the previous 12 weeks * Surgery on the brain or spinal cord, spine, ophthalmic or major surgery or injury in the last 90 days * Gastrointestinal tract disorders that can disrupt the absorption of the study drug (Crohn's disease, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The total venosus thromboembolism (VTE) index

Timeframe: 14 Days

Trial details

NCT IDNCT05189002

SponsorPharmaDiall Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-31

View on ClinicalTrials.gov More Venous Thromboembolism trials