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

NCT06312475 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Hemophilia A With Inhibitor
  • Hemophilia B With Inhibitor

Interventions

DRUG

KN057

KN057 will be administered subcutaneously once a week.

Sponsors & Collaborators

  • Suzhou Alphamab Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Rong Zhou, Doctor · The Third People's Hospital of Chengdu

  • Renchi Yang, Doctor · Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

  • Jing Sun, Doctor · Nanfang Hospital, Southern Medical University

  • Hu Zhou, Doctor · Henan Cancer Hospital

  • Changcheng Zheng, Doctor · The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

  • Xielan Zhao, Doctor · Xiangya Hospital of Central South University

  • Lili Chen, Doctor · Tai Zhou First People's Hospital

  • Chenghao Jin, Doctor · Jiangxi Provincial People's Hopital

  • Yanping Song, Doctor · Xi'an Central Hospital

  • Yaming Xi, Doctor · LanZhou University

  • Zeping Zhou, Doctor · The Second Affiliated Hospital of Kunming Medical University

  • Runhui Wu, Doctor · Beijing Children's Hospital

  • Ziqiang Yu, Doctor · The First Affiliated Hospital of Soochow University

  • Jingyu Yan, Doctor · North China University of Science and Technology

  • Sujun Gao, Doctor · The First Hospital of Jilin University

  • Wei Yang, Doctor · Shengjing Hospital of China University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2025-10-15
Completion
2025-12-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312475 on ClinicalTrials.gov