Total Knee ReplacementPhase 2NCT03088358
Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
A Phase 2 study testing TeaRx and Enoxaparin in people with Total Knee Replacement, run by TeaRx LLC at 8 sites in Russia.
Trial summary
To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group: Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality Incidence of DVT (total, proximal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- TeaRx and Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 8 sitesRussia
- Study dates
- Aug 2013to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 18 years;
- Planned total knee replacement surgery;
- Signed informed consent form;
- Willing to comply with the protocol;
- Willing to use adequate contraception during the trial.
Who cannot join
- Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
- History of venous thrombosis of any location or PE
- History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
- History of evident coagulopathy or in a relative
- Congenital thrombophilia
- Bleeding within 6 months of screening; increased risk of bleeding
Show all 13Show fewer
- BMI less than 18,5 or more than 40 kg/m2
- Systolic BP > 180 mmHg and/or diastolic BP > 110 mmHg registered twice within 15-30 minutes
- Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male
- Platelets < 100 000/mm3
- Clinical significant abnormalities of APTT and/or INR
- GFR < 30 ml/min/1.73 m2
- ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
Kazan', 420064
Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
Moscow, 105203
SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation
Moscow, 119435
SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin
Moscow, 125284
FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation
Nizhny Novgorod, 603155
SBHI "City Clinical Hospital № 4" of the city of Orenburg
Orenburg, 460000
St. Petersburg State Institution of Health "City Hospital № 2"
Saint Petersburg, 194354
SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov
Yaroslavl, 150003
About this study
Official title: A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:
- Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality
- Incidence of DVT (total, proximal, distal)
- Incidence of nonfatal PE
- Incidence of symptomatic VTE (DVT, PE)
- VTE caused mortality
- Non-VTE caused mortality
- Incidence of all hemorrhagic complications
- Incidence of major and clinically relevant non-major bleeding
- Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results
- Conditions
- Total Knee Replacement
- Being tested
- TeaRx, Enoxaparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeaRxDrug
Also called TeaRxaban
EnoxaparinDrug
Also called Clexane ®
| Study group | Role | What they receive |
|---|---|---|
| TeaRx 50 mg | Experimental | TeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days) Receives: Drug: TeaRx |
| TeaRx 100 mg | Experimental | TeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days) Receives: Drug: TeaRx |
| TeaRx 150 mg | Experimental | TeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days) Receives: Drug: TeaRx |
| Enoxaparin | Active comparator | Enoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days) Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)
Measured: 6 weeks following total knee replacement
Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)
Measured: 6 weeks following total knee replacement
Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)
Measured: 6 weeks following total knee replacement
venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)
Measured: 6 weeks following total knee replacement
Non-VTE caused mortality (efficacy of the selected TeaRx dose)
Measured: 6 weeks following total knee replacement
AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)
Measured: 6 weeks following total knee replacement
Secondary outcomes (1)
Incidence of bleeding (safety of selected TeaRx dose)
major and clinically relevant non-major bleeding
Measured: 6 weeks following total knee replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study startAug 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- TeaRx LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail N. Zamyatin, Prof., Study chair, Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088358
- Sponsor's protocol ID
- CV-TRX-01
- Status last verified
- Mar 2017
- First submitted
- 26 Feb 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03088358
- Acronym / sponsor ID
- CV-TRX-01
- Conditions
- Total Knee Replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- TeaRx LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:
- Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality
- Incidence of DVT (total, proximal, distal)
- Incidence of nonfatal PE
- Incidence of symptomatic VTE (DVT, PE)
- VTE caused mortality
- Non-VTE caused mortality
- Incidence of all hemorrhagic complications
- Incidence of major and clinically relevant non-major bleeding
- Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TeaRx 50 mg | Experimental | Drug: TeaRxTeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days) |
| TeaRx 100 mg | Experimental | Drug: TeaRxTeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days) |
| TeaRx 150 mg | Experimental | Drug: TeaRxTeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days) |
| Enoxaparin | Active comparator | Drug: EnoxaparinEnoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age ≥ 18 years;
- Planned total knee replacement surgery;
- Signed informed consent form;
- Willing to comply with the protocol;
- Willing to use adequate contraception during the trial.
Key exclusion criteria (13 listed)
- Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
- History of venous thrombosis of any location or PE
- History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
- History of evident coagulopathy or in a relative
- Congenital thrombophilia
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 |
|---|---|---|
| TeaRxAlso: TeaRxaban | Drug | TeaRx 100 mg, TeaRx 150 mg, TeaRx 50 mg |
| EnoxaparinAlso: Clexane ® | Drug | Enoxaparin |
Primary outcome
Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
Non-VTE caused mortality (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
1 secondary outcome
Incidence of bleeding (safety of selected TeaRx dose)
Time frame: 6 weeks following total knee replacement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Mikhail N. Zamyatin, Prof. study chair
Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TeaRx and Enoxaparin in people with Total Knee Replacement, run by TeaRx LLC at 8 sites 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 5 inclusion and 13 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose) (time frame: 6 weeks following total knee replacement). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2017.