Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-01-07 @ 2:01 PM
Study NCT ID:
NCT06963320
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Study of H001 Capsule in the Prevention of Venous Thromboembolism After Total Knee Arthroplasty
Sponsor:
Livzon Pharmaceutical Group Inc.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: