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Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B With Inhibitors | Clinical Trials | Clareo Health

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

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

NCT06312475•Suzhou Alphamab Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - 70 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. 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;
•2. 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;
•3. ≥6 treated bleeding episodes within 26 weeks before screening;
•4. Have not used TFPI antibody drugs before;
•5. Be able and agree to elute prior drugs for the treatment of hemophilia.

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. 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);
•6. Ongoing or planned Immune Tolerance Induction treatment;
•7. When bleeding occurred in the past, rFVIIa was ineffective and PCC treatment must be used;
•8. Known or suspected hypersensitivity to any constituent of the trial product or related products;
•9. Have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study.

Locations (1)

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

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

January 9, 2024

Primary Completion Date

October 15, 2025

Completion Date

December 15, 2025

Last Updated

September 17, 2025

Enrollment

ACTUAL participants

Conditions

Hemophilia A With InhibitorHemophilia B With Inhibitor

Interventions

KN057

DRUG

ATHN 7: Hemophilia Natural History Study

NCT03619863

Hemophilia A With InhibitorHaemophilia A Without Inhibitor+2 more

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COMPLETED

An Exploration of the Impact of Emicizumab on the Lives of People With Haemophilia and Inhibitors and Their Families

NCT04723693

Hemophilia A With Inhibitor

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ATHN 7: Hemophilia Natural History Study

An Exploration of the Impact of Emicizumab on the Lives of People With Haemophilia and Inhibitors and Their Families

The Hemophilia Inhibitor Eradication Trial

Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders

INdividualized ITI Based on Fviii(ATE) Protection by VWF

rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors