Venous ThromboembolismPhase 2COURSENCT03812328
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
A Phase 2 study testing SelK2 and Enoxaparin in people with Venous Thromboembolism, run by Tetherex Pharmaceuticals Corporation at 21 sites in 5 countries.
Trial summary
The main purpose of this study is to determine if an investigational medication called SelK2 works in preventing a condition called "venous thromboembolism" (VTE) in patients having a total knee replacement. SelK2 has been designed to attach to a protein found on blood cells and blood vessels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- SelK2 and Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 20 Feb 2019to 14 Nov 2019
- Phase
- Phase 2
- 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
- Males or females, 18-80 years of age (inclusive)
- Planned to undergo elective, primary total unilateral Total Knee Arthroplasty under general anesthesia
Who cannot join
- Previous deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) within the past year
- Any underlying condition (e.g., atrial fibrillation, mechanical heart valve, or recent pulmonary embolism) that may lead to the required concomitant use of anticoagulants/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, apixaban, clopidogrel) that may affect study outcome or any other drug influencing coagulation (except low dose aspirin (100 mg or less))
- Anticipated use of intermittent pneumatic compression devices and/or electrical/mechanical muscle stimulators post Total Knee Arthroplasty procedure
Trial locations and contacts
21 sites in 5 countries.
21 sites in 5 countries
Poland7 sites
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok
Samodzielny Publiczny Zakład Opieki Zdrowotnej
Bielsk Podlaski
Szpital Ogólny im. dr Witolda Ginela w Grajewie
Grajewo
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz
Wojewódzki Szpital Specjalistyczny
Lublin
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw
Latvia5 sites
Regional Hospital of Liepaja
Liepāja
Hospital of Traumatology and Orthopaedics
Riga
ORTO Clinic
Riga
Riga's 2nd Hospital
Riga
Vidzemes Hospital
Valmiera
Ukraine4 sites
Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council
Cherkasy
Center of Traumatology & Orthopedics
Chernivtsi
Ivano-Frankivsk Regional Clinical Hospital
Ivano-Frankivsk
Kiev Regional Clinical Hospital
Kiev
Bulgaria3 sites
UMHAT Kanev AD
Rousse
Acibadem City Clinic Tokuda Hospital EAD
Sofia
UMHAT Tsaritsa Yoanna - ISUL
Sofia
Lithuania2 sites
Kaunas Clinical Hospital
Kaunas
Klaipeda University Hospital
Klaipėda
About this study
Official title: A Phase 2, Randomized, Active Comparator-Controlled, Open-Label, Adaptive Design Study to Assess the Safety and Efficacy of Intravenously-Administered SelK2 in Patients Undergoing Total Knee Arthroplasty
The main purpose of this study is to determine if an investigational medication called SelK2 works in preventing a condition called "venous thromboembolism" (VTE) in patients having a total knee replacement. SelK2 has been designed to attach to a protein found on blood cells and blood vessels. By attaching to this protein, SelK2 is designed to decrease the inflammatory process in the blood vessel wall that leads to the formation of blood clots in the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood thinner, it is expected that the risk for bleeding will also be reduced.
- Conditions
- Venous Thromboembolism
- Being tested
- SelK2, Enoxaparin
- Keywords
- venous thromboembolism, adhesion molecule, P-selectin glycoprotein ligand 1, P-selectin, venous thrombosis
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelK2Drug
I.V., single-dose
EnoxaparinBiological
Also called Lovenox
SC, QD for up to 10 ± 2 days
| Study group | Role | What they receive |
|---|---|---|
| SelK2 and Enoxaparin | Experimental | I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin) Receives: Drug: SelK2; Biological: Enoxaparin |
| Enoxaparin | Active comparator | SC, QD for up to 10 ± 2 days Receives: Biological: Enoxaparin |
| SelK2 | Experimental | I.V., single-dose Receives: Drug: SelK2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Total Venous Thromboembolism
The primary efficacy endpoint was incidence of total VTE (reported as a percentage of patients) during the Treatment Phase up to venography day (10 ± 2 days after total knee replacement). All efficacy endpoint data was adjudicated by the blinded Central Independent Adjudication Committee (CIAC).
Measured: 10 ± 2 Days After Total Knee Replacement
Percentage of Participants With Major or Clinically Relevant Non-major Bleeding Events
All suspected bleeding events were reviewed by the Central Independent Adjudication Committee (CIAC) in a blinded fashion and were adjudicated for categorization as Major Bleeding (MB), Clinically Relevant Non-Major Bleeding (CRNMB), Minor Bleeding, or combination of MB and CRNMB. The outcome measure assessed the incidence of MB or CRNMB.
Measured: 10 ± 2 Days After 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 Jan 2019
- Study start20 Feb 2019
- Primary completion1 Oct 2019
- Study completion14 Nov 2019
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 Venous ThromboembolismStudies 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
- Model description
- This was an adaptive design study. The first two arms of the study enrolled patients in a 1:1 ratio to receive either SelK2 or an active comparator. The adaptive arm (SelK2 plus active comparator) was initiated at the discretion of the Steering and Safety Committee. The study then enrolled patients in a 2:1 ratio to receive either SelK2 with an active comparator or an active comparator only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetherex Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Rother, Ph.D., Study director, Tetherex Pharmaceuticals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812328
- Sponsor's protocol ID
- SELK2-00005
- Other IDs
- 2018-003122-88, 2018
- Acronym
- COURSE
- Status last verified
- Dec 2020
- First submitted
- 18 Jan 2019
- Last updated
- 6 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Active Comparator-Controlled, Open-Label, Adaptive Design Study to Assess the Safety and Efficacy of Intravenously-Administered SelK2 in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03812328
- Acronym / sponsor ID
- COURSE / SELK2-00005
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboembolism, adhesion molecule, P-selectin glycoprotein ligand 1, P-selectin, venous thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Tetherex Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine if an investigational medication called SelK2 works in preventing a condition called "venous thromboembolism" (VTE) in patients having a total knee replacement. SelK2 has been designed to attach to a protein found on blood cells and blood vessels. By attaching to this protein, SelK2 is designed to decrease the inflammatory process in the blood vessel wall that leads to the formation of blood clots in the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood thinner, it is expected that the risk for bleeding will also be reduced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This was an adaptive design study. The first two arms of the study enrolled patients in a 1:1 ratio to receive either SelK2 or an active comparator. The adaptive arm (SelK2 plus active comparator) was initiated at the discretion of the Steering and Safety Committee. The study then enrolled patients in a 2:1 ratio to receive either SelK2 with an active comparator or an active comparator only.
| Arm | Type | Receives |
|---|---|---|
| SelK2 and Enoxaparin | Experimental | Drug: SelK2, Biological: EnoxaparinI.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin) |
| Enoxaparin | Active comparator | Biological: EnoxaparinSC, QD for up to 10 ± 2 days |
| SelK2 | Experimental | Drug: SelK2I.V., single-dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females, 18-80 years of age (inclusive)
- Planned to undergo elective, primary total unilateral Total Knee Arthroplasty under general anesthesia
Key exclusion criteria (3 listed)
- Previous deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) within the past year
- Any underlying condition (e.g., atrial fibrillation, mechanical heart valve, or recent pulmonary embolism) that may lead to the required concomitant use of anticoagulants/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, apixaban, clopidogrel) that may affect study outcome or any other drug influencing coagulation (except low dose aspirin (100 mg or less))
- Anticipated use of intermittent pneumatic compression devices and/or electrical/mechanical muscle stimulators post Total Knee Arthroplasty procedure
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 |
|---|---|---|
| SelK2I.V., single-dose | Drug | SelK2, SelK2 and Enoxaparin |
| EnoxaparinAlso: LovenoxSC, QD for up to 10 ± 2 days | Biological | Enoxaparin, SelK2 and Enoxaparin |
Primary outcome
Percentage of Participants With Total Venous Thromboembolism
Time frame: 10 ± 2 Days After Total Knee Replacement
The primary efficacy endpoint was incidence of total VTE (reported as a percentage of patients) during the Treatment Phase up to venography day (10 ± 2 days after total knee replacement). All efficacy endpoint data was adjudicated by the blinded Central Independent Adjudication Committee (CIAC).
Percentage of Participants With Major or Clinically Relevant Non-major Bleeding Events
Time frame: 10 ± 2 Days After Total Knee Replacement
All suspected bleeding events were reviewed by the Central Independent Adjudication Committee (CIAC) in a blinded fashion and were adjudicated for categorization as Major Bleeding (MB), Clinically Relevant Non-Major Bleeding (CRNMB), Minor Bleeding, or combination of MB and CRNMB. The outcome measure assessed the incidence of MB or CRNMB.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Russell Rother, Ph.D. study director
Tetherex Pharmaceuticals Corporation
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SelK2 and Enoxaparin in people with Venous Thromboembolism, run by Tetherex Pharmaceuticals Corporation at 21 sites in 5 countries.
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 2 inclusion and 3 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Poland, Latvia, Ukraine, Bulgaria, Lithuania. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2020). 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?
Percentage of Participants With Total Venous Thromboembolism (time frame: 10 ± 2 Days After Total Knee Replacement). The study lists 2 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 6 Jan 2021.