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

NCT05189002 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-05-02

No results posted yet for this study

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 %).

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Dimolegin 40 mg

Dimolegin - DD217 - 40 mg

DRUG

Dimolegin 60 mg

Dimolegin - DD217 - 60 mg

DRUG

Fragmin

Fragmin 5000 IU in 0.2 ML Prefilled Syringe

Sponsors & Collaborators

  • PharmaDiall Ltd.

    lead OTHER

Principal Investigators

  • Dmitry A Napalkov, Professor · Department of Faculty Therapy No. 1 of the Sechenov University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2021-08-31
Completion
2022-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05189002 on ClinicalTrials.gov