Safety of KN057 Prophylaxis in Patients With Haemophilia A or B (NCT07545395) | Clinical Trial Compass
RecruitingPhase 3
Safety of KN057 Prophylaxis in Patients With Haemophilia A or B
China70 participantsStarted 2026-03-13
Plain-language summary
The purposes of this open-label, multicenter III clinical trial are to evaluate the safety and efficacy of long-term preventive treatment with KN057 in Haemophilia A or B patients with or without inhibitors, and to assess the pharmacokinetic characteristics of the new and old processes KN057.
The participants in Part PK will be randomly assigned to Old process Group or New process Group in a 1:1 ratio. The participants in Old process Group will receive old process KN057 prophylaxis for the first 26 weeks and new process KN057 prophylaxis for the following 26 weeks. The participants in New process Group will receive new process KN057 prophylaxis for both the first 26 weeks and the last 26 weeks.
The participants in Part non-PK will be non-randomized and treated with new process KN057 for 52 weeks prophylaxis after enrollment.
Priority screening and enrollment of participants who have participated in the KN057-A-301 or KN057-A-302 study.
Who can participate
Age range
12 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male, 12 to 65 years old at the time of signing informed consent, body weight ≥30 kg and BMI \<28 kg/m\^2 at screening.
. For participates with inhibitors: Tested positive for high-titer FVIII or FIX inhibitors (≥ 5 BU/mL) at screening; or tested positive for low-titer FVIII or FIX inhibitors (0.6 BU/mL or upper limit of normal \[ULN\] \< inhibitor titer \< 5 BU/mL) at screening, with ongoing treatment using bypassing agents (rFVIIa or PCC).
. Participates with inhibitors agree to avoid using PCC for treatment when breakthrough bleeding occurred. Participates without inhibitors agree to be treated with standard half-life coagulation factors (FVIII or FIX) in the event of breakthrough bleeding.
Exclusion criteria
. Have serious or poorly controlled chronic diseases or obvious systemic diseases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of TEAE.
Timeframe: Up to 12/26/56 weeks.
2
Incidence of TEAE related to the experimental drug.
Timeframe: Up to 12/26/56 weeks.
3
Incidence of SAE.
Timeframe: Up to 12/26/56 weeks.
4
Incidence of thromboembolic events.
Timeframe: Up to 12/26/56 weeks.
5
Incidence of TMA and DIC.
Timeframe: Up to 12/26/56 weeks.
6
Incidence of hypersensitivity type reactions.
Timeframe: Up 12/26/56 weeks.
7
Incidence of injection site reactions.
Timeframe: Up to 12/26/56 weeks.
8
Incidence of clinically significant laboratory value abnormalities.
. Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy.
. Have high-risk factors for thrombosis: such as atrial fibrillation, atherosclerotic diseases of important arteries, ischemic disease of important organs, vascular occlusive disease, autoimmune diseases with a high risk of thrombosis, or indwelling central venous catheter.
. Known or suspected hypersensitivity to any constituent of the trial product or related products.
. Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study.
. Used Emicizumab treatment within 6 months before screening.
. Have received any gene therapy for hemophilia in the past.
. Other factors that the investigator deems inappropriate for participating in this trial, such as the presence of concomitant diseases, treatment or examination abnormalities that affect the subject's safety during the trial or affect the interpretation of trial results.
Timeframe: Up to 12/26/56 weeks.
9
Number of participants with clinically significant changes from baseline in electrocardiograms.
Timeframe: Up to 12/26/56 weeks.
10
Number of participants with clinically significant changes from baseline in vital signs.
Timeframe: Up to 12/26/56 weeks.
11
Number of participants with clinically significant changes from baseline in physical exam.