Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty

NCT06963320 | Recruiting Phase 2

• 1 other identifier: LZ-033-II
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Circulatory Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of total VTE

  Within 14 days post-dose

Secondary Outcomes (9)

• Major bleeding and clinically relevant non-major bleeding

  Within 14 days post-dose

• Incidence of total DVT

  Within 14 days post-dose

• Incidence of Proximal DVT

  Within 14 days post-dose

• Incidence of Distal DVT

  Within 14 days post-dose

• Incidence of Total VTE

  Within 42 days post-dose

Study Arms (4)

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

Interventions

H001 Capsule 200mg-qd DRUG

H001 Capsule, 50 mg/capsule, 200 mg orally once daily for 10-14 days.

H001 Capsule 200mg-qd

Enoxaparin Sodium Injection DRUG

Enoxaparin Sodium Injection,0.4 mL: 4000 AXaIU, 40 mg subcutaneously once daily for 10-14 days

Enoxaparin Sodium Injection

H001 Capsule 300mg-qd DRUG

H001 Capsule, 50 mg/capsule, 300 mg orally once daily for 10-14 days.

H001 Capsule 300mg-qd

H001 Capsule 200mg-bid DRUG

H001 Capsule, 50 mg/capsule, 200 mg orally twice daily for 10-14 days.

H001 Capsule 200mg-bid

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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).

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

enoxaparin sodium; BID protein, human

Central Study Contacts

Xianlong Zhang, Dr.

CONTACT

+86-18930177324; Zxl40@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: January 20, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Locations

CN (1)