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Prevention study for Circulatory Disease
Official title Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT06963320
What this study is testing
What is H001 Capsule 200mg-qd?
H001 Capsule 200mg-qd is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for circulatory disease.
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 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.
- 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 18 to 74
You may be able to join if
- 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 people whose partners are women of childbearing potential must agree to use effective contraception throughout the...
You likely can't join if
- Pregnant or breastfeeding female people;
- 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...
- High bleeding risk or contraindications to enoxaparin (e.g., known or suspected heparin-induced thrombocytopenia, severe hematologic disorders...
- History of deep vein thrombosis (DVT) or DVT confirmed during screening;
- Clinically significant medical history, including
See the full eligibility criteria
- 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 people whose partners are women of childbearing potential must agree to use effective contraception throughout the study period. Acceptable methods include oral, implantable, or...
- Pregnant or breastfeeding female people;
- 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...
- High bleeding risk or contraindications to enoxaparin (e.g., known or suspected heparin-induced thrombocytopenia, severe hematologic disorders, severe coagulation abnormalities);
- History of deep vein thrombosis (DVT) or DVT confirmed during screening;
- Clinically significant medical history, including
- Hemorrhagic stroke or intracranial conditions (e.g., hemorrhage, tumor, arteriovenous malformation, or aneurysm);
- Recurrent upper gastrointestinal or genital/urinary tract ulcers/bleeding, intraocular bleeding, or clinical bleeding within 6 months prior to screening (as judged by the investigator to increase bleeding risk);
- Acute hepatitis within 1 year prior to screening or persistent severe liver disease (e.g., chronic active hepatitis, cirrhosis, or chronic hepatic insufficiency);
- Myocardial infarction, acute coronary syndrome, viral myocarditis, pulmonary embolism, or coronary revascularization within 6 months prior to screening; transient ischemic attack or ischemic stroke;
- Chronic congestive heart failure with NYHA Class IV cardiac function;
- Severe arrhythmias requiring Class Ia or III antiarrhythmic drugs; sinus node dysfunction, Type II Mobitz or third-degree atrioventricular block without pacemaker implantation;
- History of QTc interval prolongation or QTc interval ≥480 ms during screening;
- Poorly controlled hypertension within 3 months prior to screening (defined as failure to achieve target blood pressure despite ≥3 antihypertensive medications) or systolic blood pressure ≥160 mmHg and/or diastolic blood...
- Major surgery or trauma within 3 months prior to screening, particularly involving the brain, spine, or eyes;
- Use of the following treatments:
- Ongoing or recent (within 7 days pre-surgery) anticoagulant therapy (e.g., after mechanical heart valve replacement) or plans to continue such therapy during the study;
- Oral antiplatelet therapy (e.g., aspirin \>165 mg/day, clopidogrel, ticlopidine, dipyridamole) within 7 days pre-surgery or plans to continue during the study;
- Long-acting NSAIDs within 7 days or 5 half-lives (whichever is longer) prior to surgery;
- Thrombolytic therapy for ischemic disease within 6 months prior to screening;
- Planned or ongoing use of epidural analgesia post-surgery; planned or ongoing use of intermittent pneumatic compression devices, electrical/mechanical muscle stimulators post-surgery; intraoperative complications (e.g...
- Laboratory abnormalities at screening:
- Total bilirubin \>1.5×ULN, ALT or AST \>3×ULN;
- Serum creatinine \>1.5×ULN; chronic kidney disease with eGFR \<30 mL/min/1.73 m²;
- Hemoglobin \<100 g/L;
- Platelet count \<100×10⁹/L;
- APTT, PT, or INR \>ULN with clinical significance (investigator judgment);
- History of malignancy within 5 years prior to screening (excluding basal cell carcinoma or Stage I squamous cell carcinoma);
- Positive serum pregnancy test (hCG) during screening;
- Participation in another drug/device clinical trial within 1 month prior to screening or within 5 half-lives of the investigational drug (whichever is longer);
- History of drug abuse or psychiatric disorders;
- Other conditions deemed unsuitable for study participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. 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.