Circulatory DiseasePhase 2NCT06963320
Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty
A Phase 2 study testing H001 Capsule 200mg-qd, Enoxaparin Sodium Injection and H001 Capsule 300mg-qd in people with Circulatory Disease, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Circulatory Disease
- What is being tested?
- H001 Capsule 200mg-qd, Enoxaparin Sodium Injection and H001 Capsule 300mg-qd
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 30 Jul 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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);
- History of deep vein thrombosis (DVT) or DVT confirmed during screening;
- Clinically significant medical history, including
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- 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 pressure ≥100 mmHg confirmed during screening;
- 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., hemorrhage or severe trauma) during spinal/epidural anesthesia;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality
Xianlong Zhang, Dr., +86-18930177324, Zxl40@vip.sina.com
About this study
Official title: 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
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
- Circulatory Disease
- Being tested
- H001 Capsule 200mg-qd, Enoxaparin Sodium Injection, H001 Capsule 300mg-qd, H001 Capsule 200mg-bid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H001 Capsule 200mg-qdDrug
H001 Capsule, 50 mg/capsule, 200 mg orally once daily for 10-14 days.
Enoxaparin Sodium InjectionDrug
Enoxaparin Sodium Injection,0.4 mL: 4000 AXaIU, 40 mg subcutaneously once daily for 10-14 days
H001 Capsule 300mg-qdDrug
H001 Capsule, 50 mg/capsule, 300 mg orally once daily for 10-14 days.
H001 Capsule 200mg-bidDrug
H001 Capsule, 50 mg/capsule, 200 mg orally twice daily for 10-14 days.
| Study group | Role | What they receive |
|---|---|---|
| H001 Capsule 200mg-qd | Experimental | Not described Receives: Drug: H001 Capsule 200mg-qd |
| H001 Capsule 300mg-qd | Experimental | Not described Receives: Drug: H001 Capsule 300mg-qd |
| H001 Capsule 200mg-bid | Experimental | Not described Receives: Drug: H001 Capsule 200mg-bid |
| Enoxaparin Sodium Injection | Active comparator | Not described Receives: Drug: Enoxaparin Sodium Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of total VTE
Measured: Within 14 days post-dose
Secondary outcomes (9)
Major bleeding and clinically relevant non-major bleeding
Measured: Within 14 days post-dose
Incidence of total DVT
Measured: Within 14 days post-dose
Incidence of Proximal DVT
Measured: Within 14 days post-dose
Incidence of Distal DVT
Measured: Within 14 days post-dose
Incidence of Total VTE
Measured: Within 42 days post-dose
Major bleeding
Measured: Within 42 days post-dose
Clinically relevant non-major bleeding
Measured: Within 42 days post-dose
Other bleeding events
Measured: Within 42 days post-dose
TEAEs, laboratory tests, ECG, vital signs, physical examination, etc.
Measured: Within 42 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start20 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Livzon Pharmaceutical Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963320
- Sponsor's protocol ID
- LZ-033-II
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06963320
- Acronym / sponsor ID
- LZ-033-II
- Conditions
- Circulatory Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Livzon Pharmaceutical Group Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| H001 Capsule 200mg-qd | Experimental | Drug: H001 Capsule 200mg-qd |
| H001 Capsule 300mg-qd | Experimental | Drug: H001 Capsule 300mg-qd |
| H001 Capsule 200mg-bid | Experimental | Drug: H001 Capsule 200mg-bid |
| Enoxaparin Sodium Injection | Active comparator | Drug: Enoxaparin Sodium Injection |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (32 listed)
- 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);
- History of deep vein thrombosis (DVT) or DVT confirmed during screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H001 Capsule 200mg-qdH001 Capsule, 50 mg/capsule, 200 mg orally once daily for 10-14 days. | Drug | H001 Capsule 200mg-qd |
| Enoxaparin Sodium InjectionEnoxaparin Sodium Injection,0.4 mL: 4000 AXaIU, 40 mg subcutaneously once daily for 10-14 days | Drug | Enoxaparin Sodium Injection |
| H001 Capsule 300mg-qdH001 Capsule, 50 mg/capsule, 300 mg orally once daily for 10-14 days. | Drug | H001 Capsule 300mg-qd |
| H001 Capsule 200mg-bidH001 Capsule, 50 mg/capsule, 200 mg orally twice daily for 10-14 days. | Drug | H001 Capsule 200mg-bid |
Primary outcome
Incidence of total VTE
Time frame: Within 14 days post-dose
9 secondary outcomes
Major bleeding and clinically relevant non-major bleeding
Time frame: Within 14 days post-dose
Incidence of total DVT
Time frame: Within 14 days post-dose
Incidence of Proximal DVT
Time frame: Within 14 days post-dose
Incidence of Distal DVT
Time frame: Within 14 days post-dose
Incidence of Total VTE
Time frame: Within 42 days post-dose
Major bleeding
Time frame: Within 42 days post-dose
Clinically relevant non-major bleeding
Time frame: Within 42 days post-dose
Other bleeding events
Time frame: Within 42 days post-dose
TEAEs, laboratory tests, ECG, vital signs, physical examination, etc.
Time frame: Within 42 days post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H001 Capsule 200mg-qd, Enoxaparin Sodium Injection and H001 Capsule 300mg-qd in people with Circulatory Disease, run by Livzon Pharmaceutical Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianlong Zhang, Dr. (+86-18930177324, Zxl40@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of total VTE (time frame: Within 14 days post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.