Hemophilia A With InhibitorPhase 3NCT06312475

Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors

A Phase 3 study testing KN057 in people with Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, run by Suzhou Alphamab Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 70 years, men only
Conditions the study is for: Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
What is being tested?: KN057
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteChina
Study dates: 9 Jan 2024to 15 Dec 2025
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 70 years
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥25 kg and BMI <28 kg/m^2 at screening;
The FVIII or FIX inhibitor test is positive at a high titer (≥5 BU/ml) during the screening period; or the FVIII or FIX inhibitor is detected at a low titer (0.6 BU/ml or the upper limit of normal value < inhibitor titer < 5 BU/ml) during the screening period and treatment with bypass agents (rFVIIa or PCC) has been started;
≥6 treated bleeding episodes within 26 weeks before screening;
Have not used TFPI antibody drugs before;
Be able and agree to elute prior drugs for the treatment of hemophilia.

Who cannot join

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 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;
The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
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);
Ongoing or planned Immune Tolerance Induction treatment;

Show all 9Show fewer

When bleeding occurred in the past, rFVIIa was ineffective and PCC treatment must be used;
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.

Trial locations and contacts

1 site in 1 country.

China1 site

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020

Other trials in China

About this study

Official title: A Randomized, Open-label Study to Evaluate the Efficacy and Safety of KN057 Injection Prophylaxis in Patients With Hemophilia A or B With Inhibitors

The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B with inhibitors and is safe to use. Successfully screened participants will be randomly assigned to KN057 Prophylaxis (Arm 1) versus No Prophylaxis (Arm 2) at a ratio of 2:1. Participants in KN057 Prophylaxis will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in No Prophylaxis will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.The trial period is 59 weeks, including a 3-week screening period, a 26-week main trial, a 26-week extension period, and a 4-week follow-up period after the last administration.

Conditions: Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Being tested: KN057

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KN057Drug
KN057 will be administered subcutaneously once a week.

Study groups in NCT06312475
Study group	Role	What they receive
Arm 1: KN057 Prophylaxis	Experimental	Successfully screened participants will be randomly assigned to KN057 Prophylaxis versus No Prophylaxis at a ratio of 2:1. Participants in Arm 1 (KN057 Prophylaxis) will receive KN057 through the main trial (26 weeks) and extension period (26 weeks) for total of approximately 1 year. Receives: Drug: KN057
Arm 2: No Prophylaxis	Experimental	Successfully screened participants will be randomly assigned to KN057 Prophylaxis versus No Prophylaxis at a ratio of 2:1. Participants in Arm 2 (No Prophylaxis) will continue on-demand treatment with their usual bypass agents (rFVIIa or PCC) through the main trial for 26 weeks, in the extension period they will switch to prophylaxis treatment and receive KN057 for 26 weeks. Receives: Drug: KN057

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized bleeding rate (ABR) calculated based on treated spontaneous and traumatic bleeding episodes in Arm 1 and Arm 2.
Treated bleeding refers to the use of bypass agents and/or coagulation factors for hemostatic treatment of the bleeding.
Measured: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total

Secondary outcomes (19)

ABR calculated based on bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1 and Arm 2.
Bleeding episodes includes spontaneous and/or traumatic bleeding episodes, excluding surgery/procedure-related bleeding episodes. Treated bleeding refers to the use of bypass agents and/or coagulation factors for hemostatic treatment of the bleeding. Target joint are those with spontaneous bleeding ≥3 times in the 6 months prior to screening.
Measured: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total
ABR calculated based on bleeding episodes and treated bleeding episodes respectively in Arm 2.
Bleeding episodes includes spontaneous and/or traumatic bleeding episodes, excluding surgery/procedure-related bleeding episodes. Treated bleeding refers to the use of bypass agents and/or coagulation factors for hemostatic treatment of the bleeding.
Measured: From Day 183 (the beginning of the extension period) to Day 365 (the end of the extension period), approximately 26 weeks in total
ABR calculated based on bleeding episodes, treated bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1.
Bleeding episodes includes spontaneous and/or traumatic bleeding episodes, excluding surgery/procedure-related bleeding episodes. Treated bleeding refers to the use of bypass agents and/or coagulation factors for hemostatic treatment of the bleeding. Target joint are those with spontaneous bleeding ≥3 times in the 6 months prior to screening.
Measured: From Day 1 (the beginning of the main trial) to Day 365 (the end of the extension period), approximately 52 weeks in total
Change from baseline in Hemophilia Joint Health Score (HJHS) scores in Arm 1 and Arm 2.
Hemophilia Joint Health Scores (HJHS) is a validated 11-item scoring tool developed for the assessment of joint health in participants with hemophilia. It comprised an evaluation of the elbows, knee and ankle joints: swelling (0 to 3), duration of swelling (0 and 1), muscle atrophy (0 to 2), crepitus on motion (0 to 2), flexion loss (0 to 3), extension loss (0 to 3), joint pain (0 to 2) and strength (0 to 4), in each item 0 = none and higher score = severe damage and global gait (walking, stairs, running, hopping on 1 leg) scored on scale ranged from 0 to 4, where 0 = all skills in normal limit and 4 = no skills within normal limits). Total HJHS score = sum of joint totals (0 to 120) + general gait (1 to 4) and ranged from 0 (no joint damage) to 124 (severe joint damage), where higher score indicated severe joint damage.
Measured: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total
Change in HJHS scores from baseline in Arm 1 and from the 26th week in Arm 2.
Hemophilia Joint Health Scores (HJHS) is a validated 11-item scoring tool developed for the assessment of joint health in participants with hemophilia. It comprised an evaluation of the elbows, knee and ankle joints: swelling (0 to 3), duration of swelling (0 and 1), muscle atrophy (0 to 2), crepitus on motion (0 to 2), flexion loss (0 to 3), extension loss (0 to 3), joint pain (0 to 2) and strength (0 to 4), in each item 0 = none and higher score = severe damage and global gait (walking, stairs, running, hopping on 1 leg) scored on scale ranged from 0 to 4, where 0 = all skills in normal limit and 4 = no skills within normal limits). Total HJHS score = sum of joint totals (0 to 120) + general gait (1 to 4) and ranged from 0 (no joint damage) to 124 (severe joint damage), where higher score indicated severe joint damage.
Measured: From Day 1 (the beginning of the main trial) to Day 365 (the end of the extension period), approximately 52 weeks in total
Change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) in Arm 1 and Arm 2.
The EQ-5D-5L questionnaire is made up for 2 components, health state description and evaluation. In description part, health status is measured in terms of 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; every dimension contains 5 levels (5L): no difficulty, a little difficulty, moderate difficulty, severe difficulty, very severe difficulty/inability to perform. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total
Change in EQ-5D-5L from baseline in Arm 1 and from the 26th week in Arm 2.
The EQ-5D-5L questionnaire is made up for 2 components, health state description and evaluation. In description part, health status is measured in terms of 5 dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; every dimension contains 5 levels (5L): no difficulty, a little difficulty, moderate difficulty, severe difficulty, very severe difficulty/inability to perform. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: From Day 1 (the beginning of the main trial) to Day 365 (the end of the extension period), approximately 52 weeks in total
Incidence of TEAE, TEAE related to the experimental drug and SAE.
TEAE refers to 'treatment emergent adverse event'. SAE refers to 'serious adverse event'.
Measured: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Incidence of thromboembolic events, TMA and DIC.
TMA refers to 'thrombotic microangiopathy'. DIC refers to 'disseminated intravascular coagulation'.
Measured: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Incidence of hypersensitivity type reactions.
Measured: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Incidence of injection site reactions.
Measured: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Incidence of clinically significant laboratory value abnormalities.
Measured: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Number of participants with clinically significant changes from baseline in physical exam.
Measured: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Number of participants with clinically significant changes from baseline in electrocardiograms.
Measured: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Number of participants with clinically significant changes from baseline in vital signs.
Measured: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
KN057 plasma trough concentration.
pharmacokinetics
Measured: From start of KN057 treatment (Day 1 for KN057 prophylaxis group, Day 183 for no prophylaxis group) to 4 weeks after the last dose of KN057, approximately 56 weeks for KN057 prophylaxis group and 30 weeks for no prophylaxis group in total
Levels of Free TFPI.
pharmacodynamics
Measured: From start of KN057 treatment (Day 1 for KN057 prophylaxis group, Day 183 for no prophylaxis group) to Day 365, approximately 52 weeks for KN057 prophylaxis group and 26 weeks for no prophylaxis group in total
Levels of prothrombin fragment 1+2 (PF1+2).
pharmacodynamics
Measured: From start of KN057 treatment (Day 1 for KN057 prophylaxis group, Day 183 for no prophylaxis group) to Day 365, approximately 52 weeks for KN057 prophylaxis group and 26 weeks for no prophylaxis group in total
Incidence of anti-KN057 antibody (ADA) and neutralizing antibody (Nab).
immunogenicity
Measured: From start of KN057 treatment (Day 1 for KN057 prophylaxis group, Day 183 for no prophylaxis group) to 4 weeks after the last dose of KN057, approximately 56 weeks for KN057 prophylaxis group and 30 weeks for no prophylaxis group in total

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jan 202415 Dec 2025

First posted15 Mar 2024
Study start9 Jan 2024
Primary completion15 Oct 2025 (estimated)
Study completion15 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hemophilia A With InhibitorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06312475
Sponsor's protocol ID: KN057-A-301
Status last verified: Sep 2025
First submitted: 30 Dec 2023
Last updated: 17 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
RecruitingPhase 3
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B
Hemophilia A, Hemophilia B
RecruitingObservational study
Treatment of Hemophilia A Patients With FVIII Inhibitors
Hemophilia A
Not yet recruitingObservational study
Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight: A Multicenter Cross-sectional Observational Study
Hemophilia A, Hemophilia
Not yet recruiting
A Study of Elranatamab for Inhibitor Eradication in Patients With Hemophilia A
Hemophilia A With Inhibitors

All Hemophilia A With Inhibitor trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study to Evaluate the Efficacy and Safety of KN057 Injection Prophylaxis in Patients With Hemophilia A or B With Inhibitors
ClinicalTrials.gov ID: NCT06312475
Acronym / sponsor ID: KN057-A-301
Conditions: Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 53 participants (actual)
Lead sponsor: Suzhou Alphamab Co., Ltd.Industry (pharma, biotech, devices)
Study start: 9 Jan 2024 (actual)
Primary completion: 15 Oct 2025 (estimated)
Study completion: 15 Dec 2025 (estimated)
First posted: 15 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1: KN057 Prophylaxis	Experimental	Drug: KN057Successfully screened participants will be randomly assigned to KN057 Prophylaxis versus No Prophylaxis at a ratio of 2:1. Participants in Arm 1 (KN057 Prophylaxis) will receive KN057 through the main trial (26 weeks) and extension period (26 weeks) for total of approximately 1 year.
Arm 2: No Prophylaxis	Experimental	Drug: KN057Successfully screened participants will be randomly assigned to KN057 Prophylaxis versus No Prophylaxis at a ratio of 2:1. Participants in Arm 2 (No Prophylaxis) will continue on-demand treatment with their usual bypass agents (rFVIIa or PCC) through the main trial for 26 weeks, in the extension period they will switch to prophylaxis treatment and receive KN057 for 26 weeks.

Who may qualify

Ages: 12 to 70 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥25 kg and BMI <28 kg/m^2 at screening;
The FVIII or FIX inhibitor test is positive at a high titer (≥5 BU/ml) during the screening period; or the FVIII or FIX inhibitor is detected at a low titer (0.6 BU/ml or the upper limit of normal value < inhibitor titer < 5 BU/ml) during the screening period and treatment with bypass agents (rFVIIa or PCC) has been started;
≥6 treated bleeding episodes within 26 weeks before screening;
Have not used TFPI antibody drugs before;
Be able and agree to elute prior drugs for the treatment of hemophilia.

Key exclusion criteria (9 listed)

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 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;
The presence of other inherited or acquired bleeding disorders other than hemophilia A and hemophilia B;
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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KN057KN057 will be administered subcutaneously once a week.	Drug	Arm 1: KN057 Prophylaxis, Arm 2: No Prophylaxis

Primary outcome

Annualized bleeding rate (ABR) calculated based on treated spontaneous and traumatic bleeding episodes in Arm 1 and Arm 2.
Time frame: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total
Treated bleeding refers to the use of bypass agents and/or coagulation factors for hemostatic treatment of the bleeding.

19 secondary outcomes

ABR calculated based on bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1 and Arm 2.
Time frame: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total
ABR calculated based on bleeding episodes and treated bleeding episodes respectively in Arm 2.
Time frame: From Day 183 (the beginning of the extension period) to Day 365 (the end of the extension period), approximately 26 weeks in total
ABR calculated based on bleeding episodes, treated bleeding episodes, treated spontaneous bleeding episodes, treated joint bleeding episodes, and treated target joint bleeding respectively in Arm 1.
Time frame: From Day 1 (the beginning of the main trial) to Day 365 (the end of the extension period), approximately 52 weeks in total
Change from baseline in Hemophilia Joint Health Score (HJHS) scores in Arm 1 and Arm 2.
Time frame: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total
Change in HJHS scores from baseline in Arm 1 and from the 26th week in Arm 2.
Time frame: From Day 1 (the beginning of the main trial) to Day 365 (the end of the extension period), approximately 52 weeks in total
Change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) in Arm 1 and Arm 2.
Time frame: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total
Change in EQ-5D-5L from baseline in Arm 1 and from the 26th week in Arm 2.
Time frame: From Day 1 (the beginning of the main trial) to Day 365 (the end of the extension period), approximately 52 weeks in total
Incidence of TEAE, TEAE related to the experimental drug and SAE.
Time frame: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Incidence of thromboembolic events, TMA and DIC.
Time frame: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Incidence of hypersensitivity type reactions.
Time frame: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Incidence of injection site reactions.
Time frame: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Incidence of clinically significant laboratory value abnormalities.
Time frame: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Number of participants with clinically significant changes from baseline in physical exam.
Time frame: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Number of participants with clinically significant changes from baseline in electrocardiograms.
Time frame: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
Number of participants with clinically significant changes from baseline in vital signs.
Time frame: From the signing of informed consent to 4 weeks after the last dose of KN057 (the end of the trial), approximately 59 weeks in total
KN057 plasma trough concentration.
Time frame: From start of KN057 treatment (Day 1 for KN057 prophylaxis group, Day 183 for no prophylaxis group) to 4 weeks after the last dose of KN057, approximately 56 weeks for KN057 prophylaxis group and 30 weeks for no prophylaxis group in total
Levels of Free TFPI.
Time frame: From start of KN057 treatment (Day 1 for KN057 prophylaxis group, Day 183 for no prophylaxis group) to Day 365, approximately 52 weeks for KN057 prophylaxis group and 26 weeks for no prophylaxis group in total
Levels of prothrombin fragment 1+2 (PF1+2).
Time frame: From start of KN057 treatment (Day 1 for KN057 prophylaxis group, Day 183 for no prophylaxis group) to Day 365, approximately 52 weeks for KN057 prophylaxis group and 26 weeks for no prophylaxis group in total
Incidence of anti-KN057 antibody (ADA) and neutralizing antibody (Nab).
Time frame: From start of KN057 treatment (Day 1 for KN057 prophylaxis group, Day 183 for no prophylaxis group) to 4 weeks after the last dose of KN057, approximately 56 weeks for KN057 prophylaxis group and 30 weeks for no prophylaxis group in total

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Individual participant dataSharing planned: No

Related trials for Hemophilia A With Inhibitor

RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
RecruitingPhase 3
A Clinical Trial of Study Medicine (Marstacimab) in Pediatric Patients With Hemophilia A or Hemophilia B
Hemophilia A, Hemophilia B
RecruitingObservational study
Treatment of Hemophilia A Patients With FVIII Inhibitors
Hemophilia A
Not yet recruitingObservational study
Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight: A Multicenter Cross-sectional Observational Study
Hemophilia A, Hemophilia
Not yet recruiting
A Study of Elranatamab for Inhibitor Eradication in Patients With Hemophilia A
Hemophilia A With Inhibitors

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Renchi Yang, Doctor principal investigator

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

Jing Sun, Doctor principal investigator

Nanfang Hospital, Southern Medical University

Hu Zhou, Doctor principal investigator

Henan Cancer Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KN057 in people with Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, run by Suzhou Alphamab Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized bleeding rate (ABR) calculated based on treated spontaneous and traumatic bleeding episodes in Arm 1 and Arm 2. (time frame: From Day 1 (the beginning of the main trial) to Day 183 (the end of the main trial), approximately 26 weeks in total). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06312475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.