Preventing blood clots in knee surgery patients
An Open, Randomized, Active-comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of Different Doses of KN060 for the Prevention of Venous Thromboembolism in Patients Undergoing Unilateral Total Knee Arthroplasty.
This study tests a new drug called KN060 to see if it works better than enoxaparin at preventing blood clots in patients having knee surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Suzhou Alphamab Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06180889 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of a new drug, KN060, against enoxaparin for preventing blood clots in patients undergoing total knee arthroplasty. It aims to assess the safety and efficacy of these treatments in reducing the risk of venous thromboembolism. Participants will be monitored for any adverse effects and the overall success of clot prevention. The study involves various dosages of KN060 to determine the optimal treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are scheduled for unilateral total knee arthroplasty.
Not a fit: Patients with a high risk of bleeding or a history of venous thromboembolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective option for preventing blood clots in patients undergoing knee surgery.
How similar studies have performed: Other studies have shown promising results with similar anticoagulant approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, aged between 18 and 75 years old (including the cut-off value); 2. undergoing unilateral Total Knee Arthroplasty (TKA); 3. Voluntarily participate in the study and sign a written informed consent; Exclusion Criteria: 1. There is a high risk of bleeding or abnormal bleeding related indicators: 2. Evidence of venous thrombosis, such as the presence of related symptoms or auxiliary tests indicating thrombosis; Or have a history of venous embolic disease. 3. Acute myocardial infarction or ischemic stroke occurred within 6 months before screening. 4. Presence of malignant tumors or history of malignant tumors.
Where this trial is running
Shanghai, Shanghai
- Shanghai Sixth People's Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xianlong Zhang, Doctor — Shanghai 6th People's Hospital
- Study coordinator: Yanrong Dong, Master
- Email: yanrongdong@alphamab.com
- Phone: +86 18914005458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.