Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
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
1 other identifier
interventional
40
1 country
18
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2025
CompletedStudy Start
First participant enrolled
March 26, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 23, 2026
April 1, 2026
1.4 years
March 13, 2025
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
12 hours effective hemostasis rate
12 hours after the first administration
Secondary Outcomes (11)
Effective hemostasis rate at the first 12 hours bleeding visit
12 hours after the first administration
12 hours excellent + good rate
12 hours after the first administration
The number of medication required for effective hemostasis within 12 hours
12 hours after the first administration
The amount of medication (U/kg) required for effective hemostasis within 12 hours
12 hours after the first administration
8-hours effective hemostasis rate
8 hours after the first administration
- +6 more secondary outcomes
Study Arms (1)
Continuous administration of STSP-0601
EXPERIMENTALInterventions
Evaluation of the Efficacy of Single-Dose and Continuous Administration of STSP-0601 Injection for the Treatment of Bleeding in Patients with Hemophilia A or B with Inhibitors
Eligibility Criteria
You may qualify if:
- ≤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.
You may not qualify if:
- Have any coagulation disorder other than hemophilia.
- Plan to receive prophylactic treatment of coagulation factor during the trail.
- Patients plan to receive Emicizumab during the trial.
- Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
- Have a history of arterial and/or venous thrombotic events.
- Platelet \<100×109/L.
- Hemoglobin\<90g/L.
- Severe liver or kidney disease.
- Severe bleeding event occurred within 4 weeks before the first administration.
- Accepted major operation or blood transfusion within 4 weeks before the first administration.
- Have a known allergy to STSP-0601.
- Pregnant, lactating, or blood pregnancy test positive female subjects
- Participate in other clinical research within 4 weeks before enrollment (except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
- Within 1 day before the first administration, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days before the first administration, prothrombin complex, FVIII, and FIX were used. Within 4 weeks, treatment with Emicizumab was received.
- Patients not suitable for the trail according to the judgment of the investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Lanzhou University First Hospital
Lanzhou, Gansu, 730000, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000, China
The First affiliated hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, 063000, China
Harbin First Hospital Hematology Tumor Research Center
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 300020, China
Huazhong University of Science and Technology Union Hospital
Wuhan, Hubei, 430022, China
Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
Jinan Central Clinical College of Shandong First Medical University
Jinan, Shandong, 250013, China
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Xi'an Central Hospital
Xi’an, Shanxi, 710000, China
Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Zhang, Ph.D
Hospital of Hematology, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2025
First Posted
April 10, 2025
Study Start
March 26, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04