NCT07140523招募中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 Co., Ltd.1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年9月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Incidence of total venous thromboembolism (VTE) events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 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.
- •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.
排除标准
- •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/1.73m
- •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.
研究组 & 干预措施
SRSD107 low dose
Experimental
Cohort 1: SRSD107, low dose level, subcutaneous (s.c.), single dose
干预措施: SRSD107 (Drug)
SRSD107 medium dose
Experimental
Cohort 2: SRSD107, medium dose level, subcutaneous (s.c.), single dose
干预措施: SRSD107 (Drug)
SRSD107 high dose
Experimental
Cohort 3: SRSD107, high dose level, subcutaneous (s.c.), single dose
干预措施: SRSD107 (Drug)
Enoxaparin
Active Comparator
Cohort 4: Enoxaparin 40 mg s.c., once a day (q.d.), 12 ±2 days post-surgery
干预措施: enoxaparin (Drug)
结局指标
主要结局
Incidence of total venous thromboembolism (VTE) events
时间窗: 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.
次要结局
- Incidence of major VTE(From the date of surgery through 12±2 days after surgery and Day 64, respectively.)
- Incidence of total VTE events(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 12±2 days after surgery.)
- Incidence of composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB)(From the Pre-surgical Period through 12±2 days after surgery.)
- Incidence of composite of MB, CRNMB, and any bleeding(From the Pre-surgical Period through 12±2 days after surgery, Day 64, and Day 169, respectively.)
- Incidence of MB(From the Pre-surgical Period through 12±2 days after surgery.)
- Incidence of CRNMB(From the Pre-surgical Period through 12±2 days after surgery.)
- Incidence of adverse events (AEs)(From Day 1 through Day 169.)
研究者
研究点 (1)
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