A Safety and Efficacy Study of BCD-080 Compared to Clexan for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries

August 31, 2016 updated by: Biocad

International Multicenter Randomized Double-blind Comparative Clinical Trial of Safety and Efficacy of BCD-080 (JSC BIOCAD, Russia) and Clexan® (Sanofi Aventis France, France) for Deep Vein Thrombosis Prophylaxis at Orthopedic Surgeries

The purpose of the study is to prove equivalence of efficacy and safety of BCD-080 and Clexan for deep vein thrombosis and embolism prophylaxis at orthopedic surgeries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will include 116 patients who are planned for hip or knee replacement. Patients will randomized in 2 groups. 1-st group will receive BCD-080 at dose 30 mg every 12 hours during 14 days after surgery, 2-d group will receive Clexane at the same dose. Efficacy assessment will include frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic), symptomatic nonlethal thromboembolia of the pulmonary artery (PATE) and venous thromboembolism death. Safety assessment will include frequency of "big", "small" and other bleedings and frequency of heparin induced thrombocytopenia.The assessment of efficacy and safety parameters will be made during the treatment and follow-up period (till 60 day).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Railroad Clinical Hospital at the station Chelyabinsk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Written informed consent
  2. Age ≥18 years and age ≤80 years
  3. Women body mass 50-110kg, men body mass 57-110 kg inclusive
  4. Patients who are planned for hip or knee replacement
  5. Willingness of patients of both sexes and their sexual partners with preserved reproductive function to use reliable methods of contraception, starting from screening and up to 4 weeks after the last dose of the studied drug. This requirement does not apply to patients who underwent surgical sterilization. Reliable methods of contraception involves a 1-barrier method combined with one of the following: spermicides/oral contraceptive
  6. Ability of the patient, in the opinion of the investigator, to meet the Protocol requirements.

Exclusion Criteria:

  1. Hypersensitivity to the components included in the formula of preparation BCD-080 (CJSC BIOCAD) Clexane (Sanofi-Avensis France, France) or medications of the same class
  2. Conditions and diseases in which there is a high risk of bleeding: cerebral aneurysm or aortic dissection, hemorrhagic stroke (including in history)
  3. Intractable hemorrhage
  4. History of documented diseases of blood coagulation (hemophilia A or B, Willebrand disease and other coagulopathies, idiopathic thrombocytopenic purpura, Heparin induced thrombocytopenia associated with thrombosis or without it, thrombohemorrhagic syndrome, etc.) in anamnesis and/or at the moment of examination
  5. Gastric or duodenal ulcer or other erosive and ulcerative lesions of gastrointestinal tract
  6. Recent ischemic stroke
  7. Uncontrolled severe hypertension; that is, all cases of hypertension, in which blood pressure decrease cannot be achieved with the use of combination of 3 antihypertensive drugs, compulsorily including a diuretic, and non-drug methods of correction (salt-free diet, graduated exercise); or if the results of two successive measurements of supine arterial blood pressure with an interval of 15-30 minutes, systolic blood pressure> 180 mm Hg. or diastolic blood pressure> 105 mm Hg
  8. Diabetic or hemorrhagic retinopathy
  9. Decompensated diabetes mellitus, diabetes mellitus complications
  10. Recent delivery (during last 90 days)
  11. Bacterial endocarditis (acute or subacute)
  12. Pericarditis and pericardial effusion
  13. Renal and/or hepatic insufficiency
  14. Intrauterine contraception
  15. Surgeries or injuries of brain/spinal cord, spine, eyes, and major surgeries and injuries within 90 days prior to randomization)
  16. Spinal surgeries or its deformation in history of patients who are planned for epidural/spinal anesthesia
  17. Active liver diseases
  18. Anamnestic information about alcoholism, addiction or drug abuse over the last year
  19. Contraindications to surgeries
  20. Hemoglobin <100 g/l
  21. Platelet count <100х10*9/l
  22. Creatine clearance <30 ml/min
  23. Biochemical blood assay indexes: AST/ALT > UNLх3; total bilirubin > UNLх1,5 (unless other causal factors provided, such as Gilbert's syndrome)
  24. Necessity for continued treatment with anticoagulants (except for planned under this study), antiaggregant and fibrinolytics (eg, patients with artificial cardiac valve, atrial fibrillation patients receiving warfarin, etc.)
  25. The use of dextrans or fibrinolytic therapy or other drugs affecting hemostasis;
  26. Necessity for use of systemic glucocorticosteroids and non-steroidal anti-inflammatory drugs (except for the use of the latter with the purpose of anaesthesia in the early postoperative period - during 3 days after the planned hip or knee replacement)
  27. Impossibility of contrast venography: contrast allergy, inability to install an intravenous catheter, etc
  28. Pregnancy, lactation period
  29. Donation of 450 ml or more of blood or plasma within 60 calendar days before inclusion enrolment
  30. Participation in clinical trials no less than 30 days before enrolment into this study or previous participation in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BCD-080
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.
Drug: Sodium Enoxaparine
30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
Other Names:
  • Clexane (Sodium Enoxaparine)
  • BCD-080 (Sodium Enoxaparine)
Active Comparator: Clexane
Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/
Drug: Sodium Enoxaparine
30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
Other Names:
  • Clexane (Sodium Enoxaparine)
  • BCD-080 (Sodium Enoxaparine)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of DVT.
Time Frame: During the treatment period (14 days)
Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).
During the treatment period (14 days)
Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)
Frequency of Venous Thromboembolism Death
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of DTV
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of DTV (proximal and/or distal; symptomatic or asymptomatic)
During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Proximal DVT
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of proximal DVT (symptomatic or asymptomatic)
During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Distal DVT
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of distal DVT (symptomatic or asymptomatic)
During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Symptomatic Nonlethal PATE
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Venous Thromboembolism Death
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Death From Other Causes
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Venous Thromboembolism (PATE and/or DTV)
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of "Big" and Clinically Significant "Small" Bleedings
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)
Frequency of "Big" Bleedings
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)
Frequency of Clinically Significant "Small" Bleedings
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)
Frequency of Clinically Significant Bleedings
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)
Frequency of Other "Small" Bleedings
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)
Frequency of All Bleedings
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)
Frequency of Heparin Induced Thrombocytopenia
Time Frame: During the treatment period (14 days)
During the treatment period (14 days)
Frequency of Strokes, Myocardial Infarction, Unstable Angina and Cardiovascular Death
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Other AE SAE
Time Frame: During the treatment period (14 days) and follow-up period (till 60-th day)
During the treatment period (14 days) and follow-up period (till 60-th day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biocad

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ashot Agahanyan, MD, Railroad Clinical Hospital at the station Chelyabinsk, Chelyabinsk, Russia
  • Principal Investigator: Pavel Andreev, MD, PhD, Railroad Clinical Hospital at the station Samara, Samara, Russia
  • Principal Investigator: Ildar Ahtyamov, Professor, State budget institution of further education "Kazan State Medical Academy" the Ministry of Health of the Russian Federation
  • Principal Investigator: Valery Zagrekov, MD, PhD, Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry of Russian Federation
  • Principal Investigator: Maxim Lucenko, MD, Treatment and rehabilitation center of Public Health Ministry of Russian Federation, Moscow
  • Principal Investigator: Alexander Sitnik, MD, PhD, State Institution "Republican Scientific and Practical Centre for Traumatology and Orthopedics" of the Ministry of Health of the Republic of Belarus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCD-080-2

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