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Compares treatment options for Venous Thromboembolism
Official title A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA
ClinicalTrials.gov ID: NCT07140523
What this study is testing
What is SRSD107?
SRSD107 is an investigational medicine, given as an once-daily, being studied as a potential treatment for venous thromboembolism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 80
You may be able to join if
- Able to provide written informed consent before any study assessment is performed.
- Male and female people, 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...
You likely can't join if
- 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...
- 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...
- Uncontrolled blood pressure at the time of screening.
See the full eligibility criteria
- Able to provide written informed consent before any study assessment is performed.
- Male and female people, 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.
- 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nové Město na Moravě, Czechia
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, 60 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nové Město na Moravě, Czechia. 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 ClinicalTrials.gov; the study team decides eligibility.