A Phase III Clinical Study on the Efficacy and Safety of STSP-0601 for Injection in Patients With Hemophilia Associated With Inhibitors, With a Multicenter, Open Evaluation Approach
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will assess the efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 70
Healthy Volunteers: f
View:
• 12 ≤age≤70 years of age.
• Hemophilia A or B patients.
• Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
• Establish proper venous access.
• There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
• Agree to use adequate contraception to avoid pregnancy.
• Provide signed informed consent.
Locations
Other Locations
China
Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
Harbin First Hospital Hematology Tumor Research Center
NOT_YET_RECRUITING
Harbin
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Jinan Central Clinical College of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
The Second Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
Lanzhou University First Hospital
NOT_YET_RECRUITING
Lanzhou
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Jiangsu Provincial Hospital
NOT_YET_RECRUITING
Nanjing
The First affiliated hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
Shenzhen Second People's Hospital
NOT_YET_RECRUITING
Shenzhen
Second hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
North China University of Science and Technology Affiliated Hospital
NOT_YET_RECRUITING
Tangshan
Hospital of Hematology, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Wenzhou People's Hospital
NOT_YET_RECRUITING
Wenzhou
Huazhong University of Science and Technology Union Hospital
NOT_YET_RECRUITING
Wuhan
Xi'an Central Hospital
NOT_YET_RECRUITING
Xi’an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Yanli Wang
wangyanli@staidson.com
010-67519614
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2026-12
Participants
Target number of participants: 32
Treatments
Experimental: Continuous administration of STSP-0601
Related Therapeutic Areas
Sponsors
Leads: Jiangsu BioJeTay Biotechnology Co., Ltd.