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

ConditionCirculatory Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorLivzon Pharmaceutical Group Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • H001 Capsule 200mg-qd

    Drug

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

  • Enoxaparin Sodium Injection

    Drug

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

  • H001 Capsule 300mg-qd

    Drug

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

  • H001 Capsule 200mg-bid

    Drug

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

Treatment groups

320 Participants
are divided into 4 treatment groups
Group A: H001 Capsule 200mg-qdExperimental treatment 1 intervention
Group B: H001 Capsule 300mg-qdExperimental treatment 1 intervention
Group C: H001 Capsule 200mg-bidExperimental treatment 1 intervention
Group D: Enoxaparin Sodium InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of total VTE

Time frame
Within 14 days post-dose

Secondary outcomes

1

Major bleeding and clinically relevant non-major bleeding

Time frame
Within 14 days post-dose
2

Incidence of total DVT

Time frame
Within 14 days post-dose
3

Incidence of Proximal DVT

Time frame
Within 14 days post-dose
4

Incidence of Distal DVT

Time frame
Within 14 days post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Livzon Pharmaceutical Group Inc.

Lead sponsor

Source ClinicalTrials.gov
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