Safety and Efficacy of STSP-0601 in Adult Patients with Hemophilia a or B with Inhibitor
- Conditions
- Hemophilia
- Interventions
- Drug: STSP-0601 for Injection
- Registration Number
- NCT06289166
- Lead Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 18 ≤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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Consecutive doses of STSP-0601 STSP-0601 for Injection -
- Primary Outcome Measures
Name Time Method Proportion of successfully treated bleeding episodes 12 hours after first administration of study drug
- Secondary Outcome Measures
Name Time Method Time to complete/significant remission from haematogenesis 72 hours after last administration of study drug Proportion of successfully treated first bleeding episodes 12 hours after first administration of study drug Proportion of bleeding episodes received salvage treatment 24 hours after first administration of study drug Proportion of successfully treated bleeding episodes 8 hours after first administration of study drug Proportion of successfully treated Target joint 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 Excellent: Pain and Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had fully eased. No additional infusion of study drug was required.
Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely eased , but had not completely disappeared. No additional infusion of study drug was required.Number of doses required for effective hemostasis 12 hours after first administration of study drug Time to complete/significant remission from first dose 72 hours after last administration of study drug
Trial Locations
- Locations (20)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, 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, 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, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China