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Tests treatment safety and results for Hemophilia A or B
Official title Safety of KN057 Prophylaxis in Patients With Haemophilia A or B
ClinicalTrials.gov ID: NCT07545395
What this study is testing
What is KN057?
KN057 is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hemophilia a or b.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 26 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65, men only
You may be able to join if
- 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...
- Participates with inhibitors agree to avoid using PCC for treatment when breakthrough bleeding occurred. Participates without inhibitors agree to be...
You likely can't join if
- Have serious or poorly controlled chronic diseases or obvious systemic diseases.
- Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with...
- Have high-risk factors for thrombosis: such as atrial fibrillation, atherosclerotic diseases of important arteries, ischemic disease of important...
- 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.
See the full eligibility 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] \<...
- 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...
- Have serious or poorly controlled chronic diseases or obvious systemic diseases.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 26 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 12 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.