2024-519688-16-00
尚未招募
2 期
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.
Sirius Therapeutics Inc.25 个研究点 分布在 6 个国家目标入组 450 人开始时间: 2025年7月1日最近更新:
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Sirius Therapeutics Inc.
- 入组人数
- 450
- 试验地点
- 25
- 主要终点
- 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
概览
简要总结
To evaluate the efficacy of SRSD107 in subjects undergoing elective, primary, unilateral total knee arthroplasty (TKA) comparing SRSD107 to enoxaparin
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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. 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
- •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
- •Activated partial thromboplastin time (aPTT), prothrombin time (PT), and international normalized ratio (INR) within the normal reference range at screening.
- •Males will agree to use contraception.
排除标准
- •Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
- •Platelet count < 100,000/m3 at screening or a history of heparin-induced thrombocytopenia.
- •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.
- •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.
- •History of intracranial, intraspinal, or intraocular bleeding.
- •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.
- •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.
- •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.
- •Estimated (by Modification of Diet in Renal Disease [MDRD]) glomerular filtration rate (eGFR) < 45 mL/min/1.73m
- •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.
结局指标
主要结局
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
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
次要结局
- Incidence of composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB) from the Pre-surgical Period through the venography visit
- 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
- Incidence of MB from the Pre-surgical Period through the venography visit
- Incidence of CRNMB from the Pre-surgical Period through the venography visit
- Incidence of adverse events (AEs) and other safety parameters throughout the study
- 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
- 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
- Incidence of total VTE events for each individual dosing cohort of SRSD107 compared to enoxaparin from the date of surgery through the venography visit
研究者
Regulatory Affairs
Scientific
Sirius Therapeutics Inc.
研究点 (25)
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