Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003122-88 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SelK2 and Enoxaparin | Experimental | I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin) |
|
| Enoxaparin | Active Comparator | SC, QD for up to 10 ± 2 days |
|
| SelK2 | Experimental | I.V., single-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SelK2 | Drug | I.V., single-dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 10 ± 2 Days After Total Knee Replacement |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Russell Rother, Ph.D. | Tetherex Pharmaceuticals Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMHAT Kanev AD | Rousse | Bulgaria | ||||
| Acibadem City Clinic Tokuda Hospital EAD |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SelK2 | I.V., single-dose |
| FG001 | SelK2 and Enoxaparin | I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2019 |
Not provided
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.
Not provided
Not provided
Not provided
| Enoxaparin |
| Biological |
SC, QD for up to 10 ± 2 days |
|
|
| Sofia |
| Bulgaria |
| UMHAT Tsaritsa Yoanna - ISUL | Sofia | Bulgaria |
| Regional Hospital of Liepaja | Liepāja | Latvia |
| Hospital of Traumatology and Orthopaedics | Riga | Latvia |
| ORTO Clinic | Riga | Latvia |
| Riga's 2nd Hospital | Riga | Latvia |
| Vidzemes Hospital | Valmiera | Latvia |
| Kaunas Clinical Hospital | Kaunas | Lithuania |
| Klaipeda University Hospital | Klaipėda | Lithuania |
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok | Poland |
| Samodzielny Publiczny Zakład Opieki Zdrowotnej | Bielsk Podlaski | Poland |
| Szpital Ogólny im. dr Witolda Ginela w Grajewie | Grajewo | Poland |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie | Krakow | Poland |
| SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi | Lodz | Poland |
| Wojewódzki Szpital Specjalistyczny | Lublin | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego | Wroclaw | Poland |
| Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council | Cherkasy | Ukraine |
| Center of Traumatology & Orthopedics | Chernivtsi | Ukraine |
| Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk | Ukraine |
| Kiev Regional Clinical Hospital | Kiev | Ukraine |
| FG002 | Enoxaparin | QD for up to 10 ± 2 days |
| Modified Intent-to-Treat (mITT) Population |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SelK2 | I.V., single-dose |
| BG001 | SelK2 and Enoxaparin | I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin) SelK2: I.V., single-dose Enoxaparin: SC, QD for up to 10 ± 2 days |
| BG002 | Enoxaparin | SC, QD for up to 10 ± 2 days Enoxaparin: SC, QD for up to 10 ± 2 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Analysis was performed on the modified intent-to-treat (mITT) population consisting of all randomized patients who also had a successful venogram or symptomatic VTE event, which allowed for assessment of the primary efficacy outcome. | Posted | Count of Participants | Participants | 10 ± 2 Days After Total Knee Replacement |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | 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. | Analysis was performed on the safety population consisting of all patients who received at least 1 dose of study drug, analyzed by actual treatment received. | Posted | Count of Participants | Participants | 10 ± 2 Days After Total Knee Replacement |
|
Through Day 57
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SelK2 | I.V., single-dose | 0 | 55 | 2 | 55 | 9 | 55 |
| EG001 | SelK2 and Enoxaparin | I.V., single-dose (SelK2) and SC, QD for up to 10 ± 2 days (Enoxaparin) SelK2: I.V., single-dose Enoxaparin: SC, QD for up to 10 ± 2 days | 0 | 63 | 3 | 63 | 6 | 63 |
| EG002 | Enoxaparin | SC, QD for up to 10 ± 2 days Enoxaparin: SC, QD for up to 10 ± 2 days | 0 | 88 | 2 | 88 | 10 | 88 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Stocker, Ph.D. | Tetherex Pharmaceuticals | 855-222-0722 | jstocker@tetherex.com |
| Oct 30, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Ukraine |
|
| Poland |
|
| Lithuania |
|
| Bulgaria |
|
| Units | Counts |
|---|
| Participants |
|
|