Actively Recruiting
Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
Led by Jiangsu BioJeTay Biotechnology Co., Ltd. · Updated on 2026-04-23
40
Participants Needed
18
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 70 years
- Diagnosed with Hemophilia A or B
- Peak historical inhibitor titer of 5 BU or higher and positive inhibitor test at enrollment
- Established proper venous access
- At least 3 bleeding events requiring treatment in the past 6 months
- Agree to use effective contraception to prevent pregnancy
- Provide signed informed consent
You will not qualify if you...
- Presence of any coagulation disorder other than hemophilia
- Planned prophylactic treatment with coagulation factors during the trial
- Planned use of Emicizumab during the trial
- Use of anticoagulant or antifibrinolytic therapy within 7 days before first dose or planned use during trial
- History of arterial or venous thrombotic events
- Platelet count below 100 x 10^9/L
- Hemoglobin level below 90 g/L
- Severe liver or kidney disease
- Severe bleeding event within 4 weeks before first dose
- Major surgery or blood transfusion within 4 weeks before first dose
- Known allergy to STSP-0601
- Pregnant, lactating, or positive pregnancy test in females
- Participation in other clinical research within 4 weeks before enrollment (except certain factor trials)
- Recent use of specific coagulation-related drugs within defined timeframes before first dose
- Considered unsuitable for the trial by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
Lanzhou University First Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
3
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
4
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
5
The First affiliated hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
6
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China, 063000
Actively Recruiting
7
Harbin First Hospital Hematology Tumor Research Center
Harbin, Heilongjiang, China, 150000
Actively Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China, 300020
Actively Recruiting
9
Huazhong University of Science and Technology Union Hospital
Wuhan, Hubei, China, 430022
Not Yet Recruiting
10
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
11
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Actively Recruiting
12
Jinan Central Clinical College of Shandong First Medical University
Jinan, Shandong, China, 250013
Actively Recruiting
13
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
14
Xi'an Central Hospital
Xi’an, Shanxi, China, 710000
Actively Recruiting
15
Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
16
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
17
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650000
Actively Recruiting
18
Wenzhou People's Hospital
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
Y
Yanli Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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