Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

Summary

The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use. Participants receiving on-demand treatment prior to screening will be randomly assigned to Experimental group or Control group at a ratio of 2:1 in Part A. Participants receiving prophylaxis prior to screening will be nonrandomly assigned to Prophylaxis group in Part B. Participants in Experimental group will receive KN057 prophylaxis for 52 weeks upon enrollment. Participants in Control group will first receive on-demand treatment for 26 weeks, then switch to KN057 prophylaxis for 26 weeks. Participants in Prophylaxis group will first receive prophylaxis with coagulation factor for 26 weeks, then switch to KN057 prophylaxis for 26 weeks.

Conditions

• Hemophilia A Without Inhibitor
• Hemophilia B Without Inhibitor

Interventions

DRUG

KN057

KN057 will be administered subcutaneously once a week.

Sponsors & Collaborators

• Suzhou Alphamab Co., Ltd.

  lead INDUSTRY

Principal Investigators

• 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

• 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

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

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

• Yun Chen, Doctor · Qianfoshan Hospital

• Pingchong Lei, Doctor · Henan Provincial People's Hospital

• Yinsuo Zheng, Doctor · Bao Ji Central Hospital

• Peng Cheng, Doctor · First Affiliated Hospital of Guangxi Medical University

• Jianwen Xiao, Doctor · Children's Hospital of Chongqing Medical University

• Ruibin Huang, Doctor · The First Affiliated Hospital of Nanchang University

• Hailiang Li, Doctor · The first affiliated hospital of jiangxi medical college

• Shu Chen, Doctor · The Second Affiliated Hospital of Chongqing Medical University

• Xiong Zhang, Doctor · Maoming City People's Hospital

• Jingyu Zhang, Doctor · The Second Hospital of Hebei Medical Hospital

• Baolai Hua, Doctor · Beijing Shijitan Hospital, Capital Medical University

• Yanming Zhang, Doctor · Huai'an Second People'Hospital

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

2024-04-01

Primary Completion

2026-10-15

Completion

2026-12-15

Countries

• China

Study Locations