Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor
A Multi-center, Open-label, Phase Ⅱb Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients with Hemophilia with Inhibitor
1 other identifier
interventional
25
1 country
20
Brief Summary
This study will assess the safety and 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_2
Started Mar 2024
Shorter than P25 for phase_2
20 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
February 23, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedStudy Start
First participant enrolled
March 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2024
CompletedJanuary 22, 2025
January 1, 2025
7 months
February 23, 2024
January 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of successfully treated bleeding episodes
12 hours after first administration of study drug
Secondary Outcomes (9)
Proportion of successfully treated first bleeding episodes
12 hours after first administration of study drug
Proportion of successfully treated bleeding episodes
8 hours after first administration of study drug
Excellent + good rate of treated bleeding episodes
12 hours after first administration of study drug
Excellent + good rate of treated bleeding episodes
8 hours after first administration of study drug
Number of doses required for effective hemostasis
12 hours after first administration of study drug
- +4 more secondary outcomes
Study Arms (1)
Consecutive doses of STSP-0601
EXPERIMENTALInterventions
A Multiple-dose Design to Evaluate the Safety, Tolerability and Efficacy of STSP-0601 for Injection in hemophilia A or B patients with inhibitor.
Eligibility Criteria
You may qualify if:
- ≤age≤70 years of age,male.
- Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
- Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled.
- Establish proper venous access.
- There were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (Only applicable to the on-demand treatment stage).
- Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
- 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 enrollment or plan to receive these drugs during the trial.Patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment.
- 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 enrollment.
- Accepted major operation or blood transfusion within 4 weeks before enrollment.
- 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 prior to enrollment, FVII, FVIIa, tranexamic acid, and aminocaproic acid were used. Within 3 days prior to enrollment, prothrombin complex, FVIII, and FIX were used. Within 4 weeks prior to enrollment, treatment with amisulumab 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 (20)
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
Fujian Medical University Affiliated Union Medical College Hospital
Fuzhou, Fujian, 350005, China
Lanzhou University First Hospital
Lanzhou, Gansu, 730000, China
Southern Medical University Southern Hospital
Guangzhou, Guangdong, 510000, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000, China
Guizhou Medical University Affiliated Hospital
Guiyang, Guizhou, 550000, China
Harbin First Hospital Hematology Tumor Research Center
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Nanjing University School of Medicine Affiliated Gulou Hospital
Nanjing, Jiangsu, 210000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330038, China
The first hospital of Jilin University
Changchun, Jilin, 130000, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110000, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Xi'an Central Hospital
Xi’an, Shanxi, 710000, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000, 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
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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2024
First Posted
March 1, 2024
Study Start
March 18, 2024
Primary Completion
October 17, 2024
Study Completion
October 17, 2024
Last Updated
January 22, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share