Study on BT-114143 Reducing Perioperative Bleeding in Total Knee Arthroplasty（TKA）

Sponsor
ScinnoHub Pharmaceutical Co., Ltd.
Study ID
NCT07127042
Phase
PHASE2
Status
Recruiting
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Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-dose BT-114143 — DRUG
    Intravenous infusion of BT-114143 Injection is started 10-15 minutes before skin incision at a Low-dose BT-114143, and 50mL of normal saline is administered intravenously 3 hours (±10 minutes) after the end of the surgery.
  • High-dose BT-14143 — DRUG
    Intravenous infusion of BT-114143 Injection is started 10-15 minutes before skin incision at a High-dose BT-114143, and 50mL of normal saline is administered intravenously 3 hours (±10 minutes) after the end of the surgery.
  • Tranexamic Acid (IV) — DRUG
    Intravenous infusion of TXA is started 10-15 minutes before skin incision at a dose of 20mg/kg, and intravenous infusion of TXA is initiated 3 hours (±10 minutes) after the end of the surgery at a dose of 1g.

Study Details

This is a randomized, double-blind, active-controlled, multicenter, phase II clinical study designed to evaluate the efficacy and safety of BT-114143 Injection in the perioperative treatment of unilateral total knee arthroplasty. It is planned to enroll 270 subjects undergoing elective unilateral open total knee arthroplasty. Subjects will be randomly assigned to the BT-114143 high-dose group, BT-114143 low-dose group, or tranexamic acid treatment group in a 1:1:1 ratio. All subjects will receive intravenous injection of BT-114143 or tranexamic acid before and after surgical incision. The total perioperative blood loss in different treatment groups will be evaluated.

Key Dates

First listed
Aug 17, 2025
Start date
Aug 27, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose Group
    High-dose BT-114143
  • Experimental: Low-dose Group
    Low-dose BT-114143
  • Active Comparator: Control Group
    Tranexamic acid

Primary Outcome Measure

Total blood loss [ Time Frame: The 3rd day after surgery ]

Central Contacts

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