This study is a multicenter, randomized, open-label, positive-controlled Phase II clinical study to evaluate the efficacy and safety of H001 capsules in the prevention of venous thromboembolism (VTE) in subjects undergoing Total Knee Arthroplasty.
Patients scheduled to undergo elective primary unilateral total knee arthroplasty (TKA);
Aged 18-74 years (inclusive) on the day of signing the informed consent form, regardless of gender;
Willing and able to voluntarily sign the informed consent form and comply with the study protocol;
Women of childbearing potential or subjects whose partners are women of childbearing potential must agree to use effective contraception throughout the study period. Acceptable methods include oral, implantable, or injectable hormonal contraceptives; mechanical products (e.g., intrauterine devices, diaphragms, condoms, spermicides); abstinence; or confirmed sterilization (e.g., vasectomy, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
Pregnant or breastfeeding female subjects;
Body weight <40 kg at screening;
History of allergy to contrast agents or inability to undergo bilateral lower limb venography; history of hypersensitivity to the study drug or drugs of the same class; known allergy to enoxaparin or any component listed in the enoxaparin prescribing information;
High bleeding risk or contraindications to enoxaparin (e.g., known or suspected heparin-induced thrombocytopenia, severe hematologic disorders, severe coagulation abnormalities);