Venous ThromboembolismPhase 2NCT07140523
A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA
A Phase 2 study testing SRSD107 and enoxaparin in people with Venous Thromboembolism, run by Sirius Therapeutics Co., Ltd. at 1 site in Czechia.
Trial summary
This is a Phase 2, multicenter, randomized, open-label, parallel group, blinded endpoint evaluation, active-controlled, dose-finding study.This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- SRSD107 and enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Sep 2025to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent before any study assessment is performed.
- Male and female subjects, of any race, between 60 and 80 years of age, inclusive.
- Body mass index between 18.0 and 35.0 kg/m2, inclusive.
- Eligible to undergo elective primary unilateral TKA under general anesthesia.
- Willing to comply with study requirements including taking study drug at least 28 days prior to TKA, clinic visits, and venography at 10-14 days post TKA.
- aPTT, PT, and INR within the normal reference range at screening.
Who cannot join
- Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
- Known bleeding disorder; history of increased bleeding tendency or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation.
- History of intracranial, intraspinal, or intraocular bleeding.
- Evidence of active cancer, or a history of malignancy, within 2 years prior to screening.
- Myocardial infarction, DVT, PE, stroke , transient ischemic attack, systemic embolism, valvular thrombosis, or splanchnic thrombosis in the 6 months prior to screening.
- Uncontrolled blood pressure at the time of screening.
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- Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2.
- Liver dysfunction, liver cirrhosis, history of hepatic encephalopathy, esophageal varices, or portocaval shunt.
- Clinically significant anemia at screening.
- Platelet counts <100,000/m3 at screening or a history of heparin-induced thrombocytopenia.
- Positive test for human immunodeficiency virus (HIV) , positive hepatitis B surface antigen, and/or active hepatitis C at screening.
- Ongoing or anticipated need for anticoagulation or antiplatelet therapy from 7 days prior to surgery through the EoS visit.
- Participation in an interventional clinical study within 5 half-lives of the investigational drug or 30 days prior to screening, whichever is longer.
- Use of any ASO or siRNA products within 1 year prior to screening. Diet and Lifestyle.
- Recent or current history of alcoholism or recreational drug abuse.
- History of hypersensitivity to any of the study drugs or its excipients, to drugs of similar chemical classes or drugs issued from the same biologic origin or any contraindication listed in the label for enoxaparin.
- Unable to undergo venography due to a known allergy to the contrast agent, anticipated poor venous access, impaired renal function, or any other reason identified and specified by the investigator.
- Anticipated elective surgery during the study period.
- Any other condition or circumstance that would affect the subject's ability to be compliant with study drug administration or study procedures, in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Hospital Nové Město na Moravě
Nové Město na Moravě
Jaroslav Pilny, 00420 776 860 404, pilny@ortopedie-traumatologie.cz
About this study
Official title: A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active Controlled Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing Elective Primary Unilateral Total Knee Arthroplasty
This is a Phase 2, multicenter, randomized, open-label, parallel group, blinded endpoint evaluation, active-controlled, dose-finding study.This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA.
Read the detailed description
This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA. While the identity of the study drug will be unblinded, the specific dose of SRSD107 will be blinded. Up to approximately 450 subjects will be randomized.
- Conditions
- Venous Thromboembolism
- Being tested
- SRSD107, enoxaparin
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRSD107Drug
SRSD107 is an investigational siRNA product for anticoagulants.
enoxaparinDrug
Also called Clexane, Lovenox
Enoxaparin is a low molecular weight heparin [LMWH] indicated for Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness.
| Study group | Role | What they receive |
|---|---|---|
| SRSD107 low dose | Experimental | Cohort 1: SRSD107, low dose level, subcutaneous (s.c.), single dose Receives: Drug: SRSD107 |
| SRSD107 medium dose | Experimental | Cohort 2: SRSD107, medium dose level, subcutaneous (s.c.), single dose Receives: Drug: SRSD107 |
| SRSD107 high dose | Experimental | Cohort 3: SRSD107, high dose level, subcutaneous (s.c.), single dose Receives: Drug: SRSD107 |
| Enoxaparin | Active comparator | Cohort 4: Enoxaparin 40 mg s.c., once a day (q.d.), 12 ±2 days post-surgery Receives: Drug: enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of total venous thromboembolism (VTE) events
Defined as deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), non-fatal and fatal PE, and unexplained death for which PE cannot be excluded.
Measured: From the date of surgery through 12±2 days after surgery.
Secondary outcomes (8)
Incidence of major VTE
Defined as objectively confirmed symptomatic DVT and PE, asymptomatic proximal DVT (confirmed by venogram), fatal PE, and unexplained death for which PE cannot be excluded.
Measured: From the date of surgery through 12±2 days after surgery and Day 64, respectively.
Incidence of total VTE events
Defined as symptomatic DVT, asymptomatic DVT (confirmed by venogram), non-fatal and fatal PE, unexplained death for which PE cannot be excluded.
Measured: From the date of surgery through Day 64.
Incidence of total VTE events for each individual dosing cohort of SRSD107 compared to enoxaparin
Defined as symptomatic DVT, asymptomatic DVT (confirmed by venogram), non-fatal and fatal PE, unexplained death for which PE cannot be excluded.
Measured: From the date of surgery through 12±2 days after surgery.
Incidence of composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB)
Based on the 2013 Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery (EMA/CHMP/325170/2012), as well as updated guidance from the International Society of Thrombosis and Haemostasis (ISTH; Schulman 2010).
Measured: From the Pre-surgical Period through 12±2 days after surgery.
Incidence of composite of MB, CRNMB, and any bleeding
Based on the 2013 Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery (EMA/CHMP/325170/2012), as well as updated guidance from the International Society of Thrombosis and Haemostasis (ISTH; Schulman 2010).
Measured: From the Pre-surgical Period through 12±2 days after surgery, Day 64, and Day 169, respectively.
Incidence of MB
Based on the 2013 Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery (EMA/CHMP/325170/2012), as well as updated guidance from the International Society of Thrombosis and Haemostasis (ISTH; Schulman 2010).
Measured: From the Pre-surgical Period through 12±2 days after surgery.
Incidence of CRNMB
Based on the 2013 Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery (EMA/CHMP/325170/2012), as well as updated guidance from the International Society of Thrombosis and Haemostasis (ISTH; Schulman 2010).
Measured: From the Pre-surgical Period through 12±2 days after surgery.
Incidence of adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Measured: From Day 1 through Day 169.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start16 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sirius Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140523
- Sponsor's protocol ID
- SRSD107-201
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2025
- Last updated
- 15 Jan 2026
- 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active Controlled Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing Elective Primary Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07140523
- Acronym / sponsor ID
- SRSD107-201
- Conditions
- Venous Thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sirius Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 24 Aug 2025 (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.
This is a Phase 2, multicenter, randomized, open-label, parallel group, blinded endpoint evaluation, active-controlled, dose-finding study.This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA.
Detailed description
This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA. While the identity of the study drug will be unblinded, the specific dose of SRSD107 will be blinded. Up to approximately 450 subjects will be randomized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SRSD107 low dose | Experimental | Drug: SRSD107Cohort 1: SRSD107, low dose level, subcutaneous (s.c.), single dose |
| SRSD107 medium dose | Experimental | Drug: SRSD107Cohort 2: SRSD107, medium dose level, subcutaneous (s.c.), single dose |
| SRSD107 high dose | Experimental | Drug: SRSD107Cohort 3: SRSD107, high dose level, subcutaneous (s.c.), single dose |
| Enoxaparin | Active comparator | Drug: enoxaparinCohort 4: Enoxaparin 40 mg s.c., once a day (q.d.), 12 ±2 days post-surgery |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide written informed consent before any study assessment is performed.
- Male and female subjects, of any race, between 60 and 80 years of age, inclusive.
- Body mass index between 18.0 and 35.0 kg/m2, inclusive.
- Eligible to undergo elective primary unilateral TKA under general anesthesia.
- Willing to comply with study requirements including taking study drug at least 28 days prior to TKA, clinic visits, and venography at 10-14 days post TKA.
Key exclusion criteria (19 listed)
- Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
- Known bleeding disorder; history of increased bleeding tendency or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation.
- History of intracranial, intraspinal, or intraocular bleeding.
- Evidence of active cancer, or a history of malignancy, within 2 years prior to screening.
- Myocardial infarction, DVT, PE, stroke , transient ischemic attack, systemic embolism, valvular thrombosis, or splanchnic thrombosis in the 6 months prior to screening.
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 |
|---|---|---|
| SRSD107SRSD107 is an investigational siRNA product for anticoagulants. | Drug | SRSD107 high dose, SRSD107 low dose, SRSD107 medium dose |
| enoxaparinAlso: Clexane, LovenoxEnoxaparin is a low molecular weight heparin [LMWH] indicated for Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness. | Drug | Enoxaparin |
Primary outcome
Incidence of total venous thromboembolism (VTE) events
Time frame: From the date of surgery through 12±2 days after surgery.
Defined as deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), non-fatal and fatal PE, and unexplained death for which PE cannot be excluded.
8 secondary outcomes
Incidence of major VTE
Time frame: From the date of surgery through 12±2 days after surgery and Day 64, respectively.
Incidence of total VTE events
Time frame: From the date of surgery through Day 64.
Incidence of total VTE events for each individual dosing cohort of SRSD107 compared to enoxaparin
Time frame: From the date of surgery through 12±2 days after surgery.
Incidence of composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB)
Time frame: From the Pre-surgical Period through 12±2 days after surgery.
Incidence of composite of MB, CRNMB, and any bleeding
Time frame: From the Pre-surgical Period through 12±2 days after surgery, Day 64, and Day 169, respectively.
Incidence of MB
Time frame: From the Pre-surgical Period through 12±2 days after surgery.
Incidence of CRNMB
Time frame: From the Pre-surgical Period through 12±2 days after surgery.
Incidence of adverse events (AEs)
Time frame: From Day 1 through Day 169.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- 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.
Hospital Nové Město na Moravě
Nové Město na Moravě, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SRSD107 and enoxaparin in people with Venous Thromboembolism, run by Sirius Therapeutics Co., Ltd. at 1 site in Czechia.
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 19 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of total venous thromboembolism (VTE) events (time frame: From the date of surgery through 12±2 days after surgery.). 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 15 Jan 2026.