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
RECRUITING
Guangzhou
Harbin First Hospital Hematology Tumor Research Center
RECRUITING
Harbin
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Jinan Central Clinical College of Shandong First Medical University
RECRUITING
Jinan
The Second Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Lanzhou University First Hospital
RECRUITING
Lanzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Provincial Hospital
RECRUITING
Nanjing
The First affiliated hospital of Guangxi Medical University
RECRUITING
Nanning
Shenzhen Second People's Hospital
RECRUITING
Shenzhen
Second hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
Hospital of Hematology, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Wenzhou People's Hospital
RECRUITING
Wenzhou
Huazhong University of Science and Technology Union Hospital
NOT_YET_RECRUITING
Wuhan
Xi'an Central Hospital
RECRUITING
Xi’an
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Yanli Wang
wangyanli@staidson.com
010-67519614
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2027-03
Participants
Target number of participants: 40
Treatments
Experimental: Continuous administration of STSP-0601
Related Therapeutic Areas
Sponsors
Leads: Jiangsu BioJeTay Biotechnology Co., Ltd.