New weekly shot aims to stop bleeds in hemophilia patients
NCT ID NCT06569108
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This Phase 3 trial tests a new drug called KN057, given as a weekly injection, to prevent bleeding in people with hemophilia A or B who do not have inhibitors. The study includes 125 males aged 12 to 70 with severe or moderately severe hemophilia. Participants are split into groups to compare KN057 against standard on-demand or preventive treatment over 52 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KN057 (a weekly injection to prevent bleeding)
- What this could lead to
- If it works, this could offer a new, convenient option to prevent bleeding episodes in people with hemophilia A or B without inhibitors.
- What could go wrong
- This is a Phase 3 trial, but results are not yet available. The drug may not reduce bleeding as hoped, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
125 people
The number who actually took part.
- Started
-
Apr 2024
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 70 years
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥30 kg and BMI \<28 kg/m\^2 at screening; 2. Severe and moderately severe hemophilia A or hemophilia B (FVIII or FIX activity level ≤2%); 3. FVIII or FIX inhibitor test is negative (\<0.6 BU/ml) or lower than the lower limit of laboratory normal values during the screening period; 4. There is no history of FVIII or FIX inhibitors in the past; or there has been an inhibitor, but it has been at least 5 years since successful immune tolerance induction therapy (ITI), and the inhibitor has not reappeared (a positive inhibitor was detected after successful ITI); 5. Use coagulation factor replacement therapy for no less than 100 exposure days before screening; 6. Have not used Anti-TFPI drugs before; 7. Be able and agree to elute the original hemophilia drugs. Participants who are enrolled into Part A must also meet the following criteria: 1. ≥6 treated bleeding episodes within 26 weeks before screening; 2. Receiving on-demand treatment, non-standard prophylaxis, or standard prophylaxis no more than 12 weeks before screening; Participants who are enrolled into Part B must also meet the following criteria: Being on standard prophylaxis and maintaining it for more than 12 weeks (standard prophylaxis is defined as at least 80% compliance with a predetermined prophylaxis regimen). Exclusion Criteria: 1. Have serious or poorly controlled chronic diseases or obvious systemic diseases; 2. Have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy; 3. Have high-risk factors for thrombosis: such as a history of coronary atherosclerotic disease, ischemic disease of important organs, vascular occlusive disease, autoimmune diseases with a high risk of thrombosis, or indwelling central venous catheter; 4. The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B; 5. Known or suspected hypersensitivity to any constituent of the trial product or related products; 6. Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study; 7. Used Emicizumab treatment within 6 months before screening; 8. Have received any gene therapy for hemophilia in the past; 9. 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hemophilia A without inhibitor are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.