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A study to test if SRSD107 prevents venous thromboembolism events and how safe it is
EU CTIS ID: 2024-519688-16-00
What this study is testing
To evaluate the efficacy of SRSD107 in subjects undergoing elective, primary, unilateral total knee arthroplasty (TKA) comparing SRSD107 to enoxaparin
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Able to provide written informed consent before any study assessment is performed.
- 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
- 3. Body mass index between 18.0 and 38.0 kg/m2, inclusive.
- 4. Eligible to undergo elective primary unilateral TKA under general anesthesia.
- 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
- 6. Activated partial thromboplastin time (aPTT), prothrombin time (PT), and international normalized ratio (INR) within the normal reference range at screening.
You likely can't join if
- 1. Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
- 10. Platelet count < 100,000/m3 at screening or a history of heparin-induced thrombocytopenia.
- 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.
- 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.
- 3. History of intracranial, intraspinal, or intraocular bleeding.
- 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.
See the full eligibility criteria
Who can join
- 1. Able to provide written informed consent before any study assessment is performed.
- 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
- 3. Body mass index between 18.0 and 38.0 kg/m2, inclusive.
- 4. Eligible to undergo elective primary unilateral TKA under general anesthesia.
- 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
- 6. Activated partial thromboplastin time (aPTT), prothrombin time (PT), and international normalized ratio (INR) within the normal reference range at screening.
- 7. Males will agree to use contraception.
What rules you out
- 1. Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
- 10. Platelet count < 100,000/m3 at screening or a history of heparin-induced thrombocytopenia.
- 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.
- 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.
- 3. History of intracranial, intraspinal, or intraocular bleeding.
- 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.
- 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.
- 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.
- 7. Estimated (by Modification of Diet in Renal Disease [MDRD]) glomerular filtration rate (eGFR) < 45 mL/min/1.73m2.
- 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.
- 9. Clinically significant anemia (hemoglobin <10 g/dL) at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- China
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine; China; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.