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

NCT02368314 | Completed Phase 3 Results

• 1 other identifier: BCD-080-2
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosis; Prophylaxis; Sodium enoxaparin

Outcome Measures

Primary Outcomes (3)

• Frequency of DVT.

  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)

  During the treatment period (14 days)

• Frequency of Venous Thromboembolism Death

  During the treatment period (14 days)

Secondary Outcomes (16)

• Frequency of DTV

  During the treatment period (14 days) and follow-up period (till 60-th day)

• Frequency of Proximal DVT

  During the treatment period (14 days) and follow-up period (till 60-th day)

• Frequency of Distal DVT

  During the treatment period (14 days) and follow-up period (till 60-th day)

• Frequency of Symptomatic Nonlethal PATE

  During the treatment period (14 days) and follow-up period (till 60-th day)

• Frequency of Venous Thromboembolism Death

  During the treatment period (14 days) and follow-up period (till 60-th day)

Study Arms (2)

BCD-080

EXPERIMENTAL

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

Clexane

ACTIVE COMPARATOR

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

Interventions

Sodium Enoxaparine DRUG

30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).

Also known as: Clexane (Sodium Enoxaparine), BCD-080 (Sodium Enoxaparine)

BCD-080; Clexane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age ≥18 years and age ≤80 years
• Women body mass 50-110kg, men body mass 57-110 kg inclusive
• Patients who are planned for hip or knee replacement
• 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
• Ability of the patient, in the opinion of the investigator, to meet the Protocol requirements.

You may not qualify if:

• 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
• Conditions and diseases in which there is a high risk of bleeding: cerebral aneurysm or aortic dissection, hemorrhagic stroke (including in history)
• Intractable hemorrhage
• 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
• Gastric or duodenal ulcer or other erosive and ulcerative lesions of gastrointestinal tract
• Recent ischemic stroke
• 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
• Diabetic or hemorrhagic retinopathy
• Decompensated diabetes mellitus, diabetes mellitus complications
• Recent delivery (during last 90 days)
• Bacterial endocarditis (acute or subacute)
• Pericarditis and pericardial effusion
• Renal and/or hepatic insufficiency
• Intrauterine contraception
• Surgeries or injuries of brain/spinal cord, spine, eyes, and major surgeries and injuries within 90 days prior to randomization)

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

Railroad Clinical Hospital at the station Chelyabinsk

Chelyabinsk, Russia

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Biryulin Andrey
• Organization: BIOCAD

biryulin@biocad.ru

+7812380 49 33

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: February 23, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 24, 2016
• Results First Posted: October 24, 2016

Record last verified: 2016-04

Locations

RU (1)