Clinical trial • Phase II • Cardiology
SRSD107 for Venous thromboembolism
Phase II trial of SRSD107 for Venous thromboembolism.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Venous thromboembolism
- Trial Stage
- Phase II
- Drug Modality
- Other RNA|Other
Key dates
- Initial CTIS Submission Date
- 06-03-2025
- First CTIS Authorization Date
- 01-07-2025
Trial design
Randomised, open-label, clexane 4.000 i. e. (40 mg)/0,4 ml solution for injection (enoxaparin sodium) — subcutaneous administration; indicated dose described as 40 mg (max daily dose 40 mg) with max treatment period 14 days. also 0.9% sodium chloride solution for injection (placebo).-controlled, adaptive Phase II trial in Poland, Bulgaria, Czechia and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Clexane 4.000 I. E. (40 mg)/0,4 ml solution for injection (enoxaparin sodium) — subcutaneous administration; indicated dose described as 40 mg (max daily dose 40 mg) with max treatment period 14 days. Also 0.9% sodium chloride solution for injection (placebo).
- Adaptive
- True, interim safety analysis planned: an interim analysis of safety data will be conducted by the SSC after 50 subjects complete 12 weeks of follow-up; pending SSC approval following this analysis, enrollment of subjects between 81 and 85 years of age (inclusive) will be allowed. The protocol also includes analyses by individual SRSD107 dosing cohorts (comparison by cohort).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 450
- Trial Duration For Participant
- 169
Eligibility
Recruits 450 Vulnerable population not selected. Participants are adults (age eligibility specified as 60–80 years, with possible extension to 81–85 pending safety review). Written informed consent is required from participants; no provisions for paediatric assent or minor consent are indicated..
- Pregnancy Exclusion
- Female subjects should not be of child-bearing potential.
- Vulnerable Population
- Vulnerable population not selected. Participants are adults (age eligibility specified as 60–80 years, with possible extension to 81–85 pending safety review). Written informed consent is required from participants; no provisions for paediatric assent or minor consent are indicated.
Inclusion criteria
- {"criterion_text":"- 1. Able to provide written informed consent before any study assessment is performed.\n- 2. Male and female subjects, of any race, between 60 and 80 years of age, inclusive. Female subjects should not be of child-bearing potential.An interim analysis of safety data will be conducted by the SSC after 50 subjects complete 12 weeks of follow-up; pending SSC approval following this analysis, enrollment of subjects between 81 and 85 years of age (inclusive) will be allowed\n- 3. Body mass index between 18.0 and 38.0 kg/m2, inclusive.\n- 4. Eligible to undergo elective primary unilateral TKA under general anesthesia.\n- 5. 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\n- 6. Activated partial thromboplastin time (aPTT), prothrombin time (PT), and international normalized ratio (INR) within the normal reference range at screening.\n- 7. Males will agree to use contraception."}
Exclusion criteria
- {"criterion_text":"- 1. Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.\n- 10. Platelet count < 100,000/m3 at screening or a history of heparin-induced thrombocytopenia.\n- 11. Positive test for human immunodeficiency virus (HIV) (CD4+>200/mm3 can be included), positive hepatitis B surface antigen, and/or active hepatitis C (by HCV RNA testing) at screening.\n- 2. Known bleeding disorder, history of increased bleeding tendency (e.g., history of bleeding diathesis, known active gastrointestinal lesions such as angiodysplasia or an endoscopically verified gastrointestinal ulcer or a history of gastrointestinal bleeding within the past year) or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation.\n- 3. History of intracranial, intraspinal, or intraocular bleeding.\n- 4. Evidence of active cancer, or a history of malignancy, within 2 years prior to screening. Nonmelanoma skin cancer, curatively treated localized breast or prostate cancer, or other carcinoma in situ are not exclusionary, providing that they did not require systemic chemotherapy (hormonal therapy allowed) and are considered cured.\n- 5. Myocardial infarction, stroke (hemorrhagic, ischemic or mixed), transient ischemic attack, systemic embolism, valvular thrombosis, or splanchnic thrombosis in the 6 months prior to screening, or any lifetime history of DVT or PE.\n- 6. Uncontrolled blood pressure as defined by a systolic blood pressure ≥ 180 mmHg and/or a diastolic blood pressure ≥ 110 mmHg at the time of screening.\n- 7. Estimated (by Modification of Diet in Renal Disease [MDRD]) glomerular filtration rate (eGFR) < 45 mL/min/1.73m2.\n- 8. Liver dysfunction (alanine aminotransaminase or aspartate aminotransferase >1.5× upper limit of normal [ULN] or total bilirubin > ULN), liver cirrhosis (Child-Pugh class B and C excluded; Child-Pugh A allowed), history of hepatic encephalopathy, esophageal varices, or portocaval shunt. Subjects with Gilbert’s syndrome are allowed to participate.\n- 9. Clinically significant anemia (hemoglobin <10 g/dL) at screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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, from the date of surgery through the venography visit. Venography will be performed 12±2 days after surgery","definition_or_measurement_approach":"VTE events defined as symptomatic DVT, asymptomatic DVT confirmed by venography of operated leg, non-fatal and fatal PE, and unexplained death where PE cannot be excluded; venography performed 12±2 days after surgery; timeframe: from date of surgery through the venography visit."}
Secondary endpoints
- {"endpoint_text":"- Incidence of composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) from the Pre-surgical Period through the venography visit","definition_or_measurement_approach":"Composite of MB and CRNMB measured from pre-surgical period through venography visit."}
- {"endpoint_text":"- Incidence of composite of MB, CRNMB, and any bleeding (including minor bleeding events) from the Pre-surgical Period through the venography visit, Day 64, and Day 169, respectively","definition_or_measurement_approach":"Composite incidence measured at three timepoints: venography visit, Day 64, and Day 169 from pre-surgical period."}
- {"endpoint_text":"- Incidence of MB from the Pre-surgical Period through the venography visit","definition_or_measurement_approach":"Major bleeding incidence measured from pre-surgical period through venography visit."}
- {"endpoint_text":"- Incidence of CRNMB from the Pre-surgical Period through the venography visit","definition_or_measurement_approach":"Clinically relevant non-major bleeding incidence measured from pre-surgical period through venography visit."}
- {"endpoint_text":"- Incidence of adverse events (AEs) and other safety parameters throughout the study","definition_or_measurement_approach":"AEs and safety parameters collected throughout entire study duration."}
- {"endpoint_text":"- Incidence of major VTE, defined as objectively confirmed symptomatic DVT and PE, asymptomatic proximal DVT, fatal PE, and unexplained death for which PE cannot be excluded, from the date of surgery through the venography visit and Day 64, respectively","definition_or_measurement_approach":"Major VTE as defined; measured through venography visit and Day 64."}
- {"endpoint_text":"- Incidence of total VTE events, defined as symptomatic DVT, asymptomatic DVT , non-fatal and fatal PE, and unexplained death for which PE cannot be excluded, from the date of surgery through Day 64","definition_or_measurement_approach":"Total VTE events measured from surgery through Day 64 with the given definitions."}
- {"endpoint_text":"- Incidence of total VTE events for each individual dosing cohort of SRSD107 compared to enoxaparin from the date of surgery through the venography visit","definition_or_measurement_approach":"Incidence of total VTE events stratified and reported by each SRSD107 dosing cohort compared to enoxaparin; timeframe from surgery through venography visit."}
Recruitment
- Planned Sample Size
- 450
- Recruitment Window Months
- 17
- Consent Approach
- Written informed consent required from each participant prior to any study assessments. Participant information sheets and ICFs are provided (main ICF and pregnant partner ICF documents present) in local languages and English as per country (documents available for Bulgaria, Poland, Czechia, Hungary, Latvia, Lithuania and English versions). No paediatric assent procedures indicated.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 450
Poland
- Earliest CTIS Part Ii Submission Date
- 29-05-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 326
- Number Of Sites
- 5
- Number Of Participants
- 68
Sites
- Site Name
- Mazowiecki Szpital Brodnowski Sp. z o.o.
- Department Name
- Klinika Ortopedii Małoinwazyjnej i Rehabilitacji
- Principal Investigator Name
- Paweł Skowronek
- Principal Investigator Email
- p.skowronek@brodnowski.pl
- Contact Person Name
- Paweł Skowronek
- Contact Person Email
- p.skowronek@brodnowski.pl
- Site Name
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
- Department Name
- Oddział Ortopedii i Traumatologii Narządu Ruchu
- Principal Investigator Name
- Grzegorz Kwiatkowski
- Principal Investigator Email
- kwiatkowskigrzegorz@gmail.com
- Contact Person Name
- Grzegorz Kwiatkowski
- Contact Person Email
- kwiatkowskigrzegorz@gmail.com
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
- Department Name
- Klinika Ortopedii i Traumatologii Narządu Ruchu
- Principal Investigator Name
- Szymon Dragan
- Principal Investigator Email
- sdragan@4wsk.pl
- Contact Person Name
- Szymon Dragan
- Contact Person Email
- sdragan@4wsk.pl
- Site Name
- Samodzileny Publiczny Zaklad Opieki Zdrowotnej W Radzyniu Podlaskim
- Department Name
- Oddział Urazowo-Ortopedyczny
- Principal Investigator Name
- Robert Węgłowski
- Principal Investigator Email
- robert.weglowski@spzozrp.pl
- Contact Person Name
- Robert Węgłowski
- Contact Person Email
- robert.weglowski@spzozrp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ
- Department Name
- Klinika Ortopedii i Traumatologii
- Principal Investigator Name
- Marcin Domżalski
- Principal Investigator Email
- marcin.domzalski@umed.lodz.pl
- Contact Person Name
- Marcin Domżalski
- Contact Person Email
- marcin.domzalski@umed.lodz.pl
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 11-06-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 310
- Number Of Sites
- 4
- Number Of Participants
- 45
Sites
- Site Name
- Mbal Lyulin EAD
- Department Name
- Department Orthopaedics and Traumatology
- Principal Investigator Name
- Ivelin Kostadinov
- Principal Investigator Email
- kostadinov68@yahoo.com
- Contact Person Name
- Ivelin Kostadinov
- Contact Person Email
- kostadinov68@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Orthopaedics and Traumatology
- Principal Investigator Name
- Keti Tokmakova
- Principal Investigator Email
- dr.ketty.tokmakova@gmail.com
- Contact Person Name
- Keti Tokmakova
- Contact Person Email
- dr.ketty.tokmakova@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
- Department Name
- First Clinic of Orthopaedics and Traumatology
- Principal Investigator Name
- Nikolay Tzonev
- Principal Investigator Email
- nikiconev@gmail.com
- Contact Person Name
- Nikolay Tzonev
- Contact Person Email
- nikiconev@gmail.com
- Site Name
- Multiprofile Hospital For Active Treatment - Shumen AD
- Department Name
- Department Orthopaedics and Traumatology
- Principal Investigator Name
- Valentin Dimitrov
- Principal Investigator Email
- dr.dimitrov.valentin@gmail.com
- Contact Person Name
- Valentin Dimitrov
- Contact Person Email
- dr.dimitrov.valentin@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-05-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 319
- Number Of Sites
- 3
- Number Of Participants
- 78
Sites
- Site Name
- Nemocnice Pardubickeho kraje a.s.
- Department Name
- Orthopaedic clinic
- Principal Investigator Name
- Petr Hoza
- Principal Investigator Email
- petr.hoza@nempk.cz
- Contact Person Name
- Petr Hoza
- Contact Person Email
- petr.hoza@nempk.cz
- Site Name
- Nemocnice Nové Město na Moravě
- Department Name
- Orthopaedics Department
- Principal Investigator Name
- Jaroslav Pilný
- Principal Investigator Email
- jaroslav.Pilny@nnm.cz
- Contact Person Name
- Jaroslav Pilný
- Contact Person Email
- jaroslav.Pilny@nnm.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Orthopaedic clinic
- Principal Investigator Name
- Luboš Nachtenbl
- Principal Investigator Email
- lubos.nachtnebl@fnusa.cz
- Contact Person Name
- Luboš Nachtenbl
- Contact Person Email
- lubos.nachtnebl@fnusa.cz
Hungary
- Earliest CTIS Part Ii Submission Date
- 05-05-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 344
- Number Of Sites
- 4
- Number Of Participants
- 71
Sites
- Site Name
- University Of Szeged
- Department Name
- Orthopedics
- Principal Investigator Name
- Krisztian Sisak
- Principal Investigator Email
- sisakkrisztian@hotmail.com
- Contact Person Name
- Krisztian Sisak
- Contact Person Email
- sisakkrisztian@hotmail.com
- Site Name
- University Of Debrecen
- Department Name
- Orthopedics
- Principal Investigator Name
- Zoltan Karacsonyi
- Principal Investigator Email
- karacsonyi.zoltan@med.unideb.hu
- Contact Person Name
- Zoltan Karacsonyi
- Contact Person Email
- karacsonyi.zoltan@med.unideb.hu
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Orthopedics
- Principal Investigator Name
- Tibor Gunther
- Principal Investigator Email
- gunther@petz.gyor.hu
- Contact Person Name
- Tibor Gunther
- Contact Person Email
- gunther@petz.gyor.hu
- Site Name
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
- Department Name
- Orthopedics
- Principal Investigator Name
- Akos Zahar
- Principal Investigator Email
- zahar.akos@gmail.com
- Contact Person Name
- Akos Zahar
- Contact Person Email
- zahar.akos@gmail.com
Latvia
- Earliest CTIS Part Ii Submission Date
- 29-05-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 320
- Number Of Sites
- 5
- Number Of Participants
- 110
Sites
- Site Name
- Traumatologijas Un Ortopedijas Slimnica SIA
- Department Name
- Traumatologist and Orthopedic
- Principal Investigator Name
- Maris Zambrans
- Principal Investigator Email
- maris.zambrans@tos.lv
- Contact Person Name
- Maris Zambrans
- Contact Person Email
- maris.zambrans@tos.lv
- Site Name
- Riga 2nd Hospital
- Department Name
- Traumatologist and Orthopedic
- Principal Investigator Name
- Sandris Petronis
- Principal Investigator Email
- sandris.petronis@gmail.com
- Contact Person Name
- Sandris Petronis
- Contact Person Email
- sandris.petronis@gmail.com
- Site Name
- Liepajas Regionala Slimnica SIA
- Department Name
- Traumatologist and Orthopedic
- Principal Investigator Name
- Uldis Argalis
- Principal Investigator Email
- uldisargalis@inbox.lv
- Contact Person Name
- Uldis Argalis
- Contact Person Email
- uldisargalis@inbox.lv
- Site Name
- Vidzemes Slimnica SIA
- Department Name
- Orthopedic
- Principal Investigator Name
- Aivars Baurovskis
- Principal Investigator Email
- ai.bau@inbox.lv
- Contact Person Name
- Aivars Baurovskis
- Contact Person Email
- ai.bau@inbox.lv
- Site Name
- Orto klinika SIA
- Department Name
- Traumatologist and Orthopedic
- Principal Investigator Name
- Andrejs Peredistijs
- Principal Investigator Email
- andrejs.peredistijs@orto.lv
- Contact Person Name
- Andrejs Peredistijs
- Contact Person Email
- andrejs.peredistijs@orto.lv
Lithuania
- Earliest CTIS Part Ii Submission Date
- 18-06-2025
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 300
- Number Of Sites
- 4
- Number Of Participants
- 78
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto Kauno ligonine
- Department Name
- orthopedist traumatologist
- Principal Investigator Name
- Juozas Belickas
- Principal Investigator Email
- juozasbelickas@gmail.com
- Contact Person Name
- Juozas Belickas
- Contact Person Email
- juozasbelickas@gmail.com
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- orthopedist traumatologist
- Principal Investigator Name
- Alfredas Smailys
- Principal Investigator Email
- alfredas.smailys@kaunoklinikos.lt
- Contact Person Name
- Alfredas Smailys
- Contact Person Email
- alfredas.smailys@kaunoklinikos.lt
- Site Name
- Klaipedos universiteto ligonine VšĮ
- Department Name
- orthopedist traumatologist
- Principal Investigator Name
- Algimantas Cebatorius
- Principal Investigator Email
- a.cebatorius@gmail.com
- Contact Person Name
- Algimantas Cebatorius
- Contact Person Email
- a.cebatorius@gmail.com
- Site Name
- Respublikine Vilniaus universitetine ligonine VšĮ
- Department Name
- orthopedist traumatologist
- Principal Investigator Name
- Igoris Satkauskas
- Principal Investigator Email
- Igoris.satkauskas@gmail.com
- Contact Person Name
- Igoris Satkauskas
- Contact Person Email
- Igoris.satkauskas@gmail.com
Sponsor
Primary sponsor
- Full Name
- Sirius Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Wuxi Apptec Co. Ltd.
- Responsibilities
- sponsorDuties codes: ["4"]
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties codes: ["4"]
- Name
- PPD International Holdings LLC
- Responsibilities
- sponsorDuties codes: ["4"]
- Name
- Fortrea Inc.
- Responsibilities
- sponsorDuties codes: ["1","11","12","13","2","5"]
- Name
- Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
- Responsibilities
- sponsorDuties codes: ["15"] (value: "PK")
- Name
- R&G PharmaStudies Co., Ltd.
- Responsibilities
- sponsorDuties codes: ["10","6"]
- Name
- ITREAS Clinical Research
- Responsibilities
- sponsorDuties codes: ["15"] (value: "Central Image")
- Name
- Medidata Information Technology (Shanghai) Co. Ltd.
- Responsibilities
- sponsorDuties codes: ["7"]
Third parties
- {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"DPO Consultancy B.V.","duties_or_roles":"sponsorDuties codes: [\"15\"] (value: \"Outsourced data protection\")","organisation_type":"Non-Pharmaceutical company"}
- {"country":"China","full_name":"Medidata Information Technology (Shanghai) Co. Ltd.","duties_or_roles":"sponsorDuties codes: [\"7\"]","organisation_type":"Industry"}
- {"country":"Germany","full_name":"Clinigen Clinical Supplies Management GmbH","duties_or_roles":"sponsorDuties codes: [\"14\"]","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"sponsorDuties codes: [\"15\"] (value: \"PK\")","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Dmed Biopharmaceutical Co. Ltd.","duties_or_roles":"sponsorDuties codes: [\"8\"]","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"R&G PharmaStudies Co., Ltd.","duties_or_roles":"sponsorDuties codes: [\"10\",\"6\"]","organisation_type":"Industry"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: [\"1\",\"11\",\"12\",\"13\",\"2\",\"5\"]","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"ITREAS Clinical Research","duties_or_roles":"sponsorDuties codes: [\"15\"] (value: \"Central Image\")","organisation_type":"Industry"}
- {"country":"China","full_name":"Shanghai Shanhu Health Technology Co. Ltd.","duties_or_roles":"sponsorDuties codes: [\"14\",\"3\"]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SRSD107 Injection
- Active Substance
- SRSD107
- Modality
- Other RNA
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Investigational; no marketing authorisation listed
- Maximum Dose
- 600 mg
- Investigational Product Name
- Clexane 4.000 I. E. (40 mg)/0,4 ml Injektionslösung in einer Fertigspritze
- Active Substance
- Enoxaparin sodium
- Modality
- Other
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation: 15854.01.00 (authorisationCountryCode: DE)
- Starting Dose
- 40 mg
- Dose Levels
- 40 mg
- Frequency
- daily
- Maximum Dose
- 40 mg
- Investigational Product Name
- 0.9% sodium chloride solution for injection
- Modality
- Other
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