Actively Recruiting
Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty
Led by Livzon Pharmaceutical Group Inc. · Updated on 2025-05-09
320
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled to undergo elective primary unilateral total knee arthroplasty (TKA)
- Aged 18-74 years (inclusive) regardless of gender
- Willing and able to voluntarily sign the informed consent form and comply with the study protocol
- Women of childbearing potential or partners of such women must agree to use effective contraception during the study period
You will not qualify if you...
- Pregnant or breastfeeding female subjects
- Body weight less than 40 kg at screening
- Allergy to contrast agents or inability to undergo bilateral lower limb venography
- Hypersensitivity to the study drug or drugs of the same class
- Known allergy to enoxaparin or any component in its prescribing information
- High bleeding risk or contraindications to enoxaparin (e.g., heparin-induced thrombocytopenia, severe hematologic disorders, coagulation abnormalities)
- History or confirmed presence of deep vein thrombosis (DVT)
- Significant medical history including hemorrhagic stroke, intracranial conditions, recent gastrointestinal or clinical bleeding, severe liver disease, recent myocardial infarction or coronary issues, severe heart failure, serious arrhythmias, prolonged QTc interval
- Poorly controlled hypertension or systolic/diastolic blood pressure above specified limits
- Major surgery or trauma within 3 months prior to screening, especially involving brain, spine, or eyes
- Recent or ongoing use of anticoagulant, oral antiplatelet, long-acting NSAIDs, or thrombolytic therapies
- Planned or ongoing use of epidural analgesia or mechanical compression devices post-surgery
- Laboratory abnormalities including elevated bilirubin or liver enzymes, high serum creatinine or low kidney function, low hemoglobin or platelet count, abnormal coagulation tests
- History of malignancy within 5 years except certain skin cancers
- Positive pregnancy test at screening
- Participation in another clinical trial recently
- History of drug abuse or psychiatric disorders
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xianlong Zhang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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