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

NCT06963320 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-05-09

No results posted yet for this study

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

Interventions

DRUG

H001 Capsule 200mg-qd

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

DRUG

Enoxaparin Sodium Injection

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

DRUG

H001 Capsule 300mg-qd

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

DRUG

H001 Capsule 200mg-bid

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

Sponsors & Collaborators

  • Livzon Pharmaceutical Group Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-06-30
Completion
2025-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06963320 on ClinicalTrials.gov