RECRUITINGPhase 3INTERVENTIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
1. 12 ≤age≤70 years of age.
2. Hemophilia A or B patients.
3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
4. Establish proper venous access.
5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
6. Agree to use adequate contraception to avoid pregnancy.
7. Provide signed willing to sign a consent form.
Who Should NOT Join This Trial:
1. Have any coagulation disorder other than hemophilia.
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 the first administration or plan to receive these drugs during the trial.
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 the first administration.
10. Accepted major operation or blood transfusion within 4 weeks before the first administration.
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 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.
15. Patients not suitable for the trail according to the judgment of the investigators.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. 12 ≤age≤70 years of age.
2. Hemophilia A or B patients.
3. Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
4. Establish proper venous access.
5. There were at least 3 bleeding events that required treatment occurred in the past 6 months before screening.
6. Agree to use adequate contraception to avoid pregnancy.
7. Provide signed informed consent.
Exclusion Criteria:
1. Have any coagulation disorder other than hemophilia.
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 the first administration or plan to receive these drugs during the trial.
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 the first administration.
10. Accepted major operation or blood transfusion within 4 weeks before the first administration.
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 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.
15. Patients not suitable for the trail according to the judgment of the investigators.
Treatments Being Tested
DRUG
STSP-0601 for Injection
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
Locations (18)
Anhui Provincial Hospital
Hefei, Anhui, China
Lanzhou University First Hospital
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The First affiliated hospital of Guangxi Medical University
Nanning, Guangxi, China
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
Harbin First Hospital Hematology Tumor Research Center
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Huazhong University of Science and Technology Union Hospital
Wuhan, Hubei, China
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jinan Central Clinical College of Shandong First Medical University
Jinan, Shandong, China
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xi'an Central Hospital
Xi’an, Shanxi, China
Sichuan Academy of Medical Sciences＆Sichuan Provincial People's Hospital
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
Wenzhou People's Hospital
Wenzhou, Zhejiang, China