Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor
NCT ID: NCT06289166
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2024-03-18
2024-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Consecutive doses of STSP-0601
STSP-0601 for Injection
A Multiple-dose Design to Evaluate the Safety, Tolerability and Efficacy of STSP-0601 for Injection in hemophilia A or B patients with inhibitor.
Interventions
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STSP-0601 for Injection
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
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Inclusion Criteria
2. Hemophilia A or B patients. (No less than 3 patients with hemophilia B)
3. Peak historical inhibitor titer ≥ 5 BU and apositive inhibitor test when enrolled.
4. Establish proper venous access.
5. 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).
6. Agree to use adequate contraception to avoid pregnancy. Agree not to donate sperm or eggs.
7. Provide signed informed consent.
Exclusion Criteria
2. Plan to receive prophylactic treatment of coagulation factor during the trail.
3. Patients plan to receive Emicizumab during the trial.
4. 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.
5. Have a history of arterial and/or venous thrombotic events.
6. Platelet \<100×109/L.
7. Hemoglobin\<90g/L.
8. Severe liver or kidney disease.
9. Severe bleeding event occurred within 4 weeks before enrollment.
10. Accepted major operation or blood transfusion within 4 weeks before enrollment.
11. Have a known allergy to STSP-0601.
12. Pregnant, lactating, or blood pregnancy test positive female subjects
13. Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails).
14. 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.
15. Patients not suitable for the trail according to the judgment of the investigators.
18 Years
70 Years
ALL
No
Sponsors
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Staidson (Beijing) Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Lei Zhang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hospital of Hematology, Chinese Academy of Medical Sciences
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Affiliated Union Medical College Hospital
Fuzhou, Fujian, China
Lanzhou University First Hospital
Lanzhou, Gansu, China
Southern Medical University Southern Hospital
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Guizhou Medical University Affiliated Hospital
Guiyang, Guizhou, China
Harbin First Hospital Hematology Tumor Research Center
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing University School of Medicine Affiliated Gulou Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The first hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Xi'an Central Hospital
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Countries
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Other Identifiers
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STSP-0601-04
Identifier Type: -
Identifier Source: org_study_id
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