Deep Vein ThrombosisPhase 3NCT02368314

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

A Phase 3 study testing Sodium Enoxaparine in people with Deep Vein Thrombosis, run by Biocad at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Deep Vein Thrombosis
What is being tested?: Sodium Enoxaparine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 124 participants
Where: 1 siteRussia
Study dates: Jan 2015to Dec 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 30Show fewer

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)
Spinal surgeries or its deformation in history of patients who are planned for epidural/spinal anesthesia
Active liver diseases
Anamnestic information about alcoholism, addiction or drug abuse over the last year
Contraindications to surgeries
Hemoglobin <100 g/l
Platelet count <100х10*9/l
Creatine clearance <30 ml/min
Biochemical blood assay indexes: AST/ALT > UNLх3; total bilirubin > UNLх1,5 (unless other causal factors provided, such as Gilbert's syndrome)
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.)
The use of dextrans or fibrinolytic therapy or other drugs affecting hemostasis;
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)
Impossibility of contrast venography: contrast allergy, inability to install an intravenous catheter, etc
Pregnancy, lactation period
Donation of 450 ml or more of blood or plasma within 60 calendar days before inclusion enrolment
Participation in clinical trials no less than 30 days before enrolment into this study or previous participation in this clinical study.

Trial locations and contacts

1 site in 1 country.

Russia1 site

Railroad Clinical Hospital at the station Chelyabinsk
Chelyabinsk

Other trials in Russia

About this study

Official title: 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.

Read the 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).

Conditions: Deep Vein Thrombosis
Being tested: Sodium Enoxaparine
Keywords: Deep vein thrombosis, Prophylaxis, Sodium enoxaparin
Medical subject headings: Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium EnoxaparineDrug
Also called Clexane (Sodium Enoxaparine), BCD-080 (Sodium Enoxaparine)
30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).

Study groups in NCT02368314
Study group	Role	What they receive
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. Receives: 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/ Receives: Drug: Sodium Enoxaparine

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of DVT.
Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).
Measured: During the treatment period (14 days)
Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)
Measured: During the treatment period (14 days)
Frequency of Venous Thromboembolism Death
Measured: During the treatment period (14 days)

Secondary outcomes (16)

Frequency of DTV
Frequency of DTV (proximal and/or distal; symptomatic or asymptomatic)
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Proximal DVT
Frequency of proximal DVT (symptomatic or asymptomatic)
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Distal DVT
Frequency of distal DVT (symptomatic or asymptomatic)
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Symptomatic Nonlethal PATE
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Venous Thromboembolism Death
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Death From Other Causes
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Venous Thromboembolism (PATE and/or DTV)
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of "Big" and Clinically Significant "Small" Bleedings
Measured: During the treatment period (14 days)
Frequency of "Big" Bleedings
Measured: During the treatment period (14 days)
Frequency of Clinically Significant "Small" Bleedings
Measured: During the treatment period (14 days)
Frequency of Clinically Significant Bleedings
Measured: During the treatment period (14 days)
Frequency of Other "Small" Bleedings
Measured: During the treatment period (14 days)
Frequency of All Bleedings
Measured: During the treatment period (14 days)
Frequency of Heparin Induced Thrombocytopenia
Measured: During the treatment period (14 days)
Frequency of Strokes, Myocardial Infarction, Unstable Angina and Cardiovascular Death
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)
Frequency of Other AE SAE
Measured: During the treatment period (14 days) and follow-up period (till 60-th day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Dec 2015

First posted23 Feb 2015 (estimated)
Study startJan 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02368314
Sponsor's protocol ID: BCD-080-2
Status last verified: Apr 2016
First submitted: 5 Feb 2015
Last updated: 24 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Enrolling by invitationObservational study
ClotTriever® Thrombectomy System Use-Result Survey in Japan
Deep Vein Thrombosis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Not yet recruiting
SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis

All Deep Vein Thrombosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02368314
Acronym / sponsor ID: BCD-080-2
Conditions: Deep Vein Thrombosis
Keywords: Deep vein thrombosis, Prophylaxis, Sodium enoxaparin
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 23 Feb 2015 (estimated)
Results: Posted 24 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
BCD-080	Experimental	Drug: Sodium EnoxaparineSodium 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.
Clexane	Active comparator	Drug: Sodium EnoxaparineSodium 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/

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (30 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium EnoxaparineAlso: Clexane (Sodium Enoxaparine), BCD-080 (Sodium Enoxaparine)30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).	Drug	BCD-080, Clexane

Primary outcome

Frequency of DVT.
Time frame: During the treatment period (14 days)
Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).
Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)
Time frame: During the treatment period (14 days)
Frequency of Venous Thromboembolism Death
Time frame: During the treatment period (14 days)

16 secondary outcomes

Frequency of DTV
Time frame: 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 Distal DVT
Time frame: 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)
Frequency of Venous Thromboembolism Death
Time frame: 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)
Frequency of Venous Thromboembolism (PATE and/or DTV)
Time frame: 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)
Frequency of "Big" Bleedings
Time frame: During the treatment period (14 days)
Frequency of Clinically Significant "Small" Bleedings
Time frame: During the treatment period (14 days)
Frequency of Clinically Significant Bleedings
Time frame: During the treatment period (14 days)
Frequency of Other "Small" Bleedings
Time frame: During the treatment period (14 days)
Frequency of All Bleedings
Time frame: During the treatment period (14 days)
Frequency of Heparin Induced Thrombocytopenia
Time frame: 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)
Frequency of Other AE SAE
Time frame: During the treatment period (14 days) and follow-up period (till 60-th day)

Results and safety

Results posted to the registry on 24 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BCD-080	64	61
Clexane	60	57

Primary outcome: Frequency of DVT.

Time frame: During the treatment period (14 days). Number. Unit: participants

Measure	BCD-080 n = 59	Clexane n = 54
Value	0	2

BCD-080 vs Clexane: p = 0.226, Fisher Exact

Population analysed: Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.

Primary outcome: Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)

Time frame: During the treatment period (14 days). Number. Unit: participants

Measure	BCD-080 n = 59	Clexane n = 54
Value	0	0

Population analysed: Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.

Primary outcome: Frequency of Venous Thromboembolism Death

Time frame: During the treatment period (14 days). Number. Unit: participants

Measure	BCD-080 n = 59	Clexane n = 54
Value	0	0

Population analysed: Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: 60 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BCD-080	2 of 64 (3.1%)	53 of 64 (82.8%)	Not reported
Clexane	5 of 59 (8.5%)	56 of 59 (94.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Deep Vein Thrombosis

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Enrolling by invitationObservational study
ClotTriever® Thrombectomy System Use-Result Survey in Japan
Deep Vein Thrombosis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Not yet recruiting
SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ashot Agahanyan, MD principal investigator

Railroad Clinical Hospital at the station Chelyabinsk, Chelyabinsk, Russia

Pavel Andreev, MD, PhD principal investigator

Railroad Clinical Hospital at the station Samara, Samara, Russia

Ildar Ahtyamov, Professor principal investigator

State budget institution of further education "Kazan State Medical Academy" the Ministry of Health of the Russian Federation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium Enoxaparine in people with Deep Vein Thrombosis, run by Biocad at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of DVT. (time frame: During the treatment period (14 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02368314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.