NCT06963320

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Livzon Pharmaceutical Group Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-06-30
• Completion: 2025-07-30
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: China