Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor

Hemophilia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289166
• Other study ID #: STSP-0601-04
• Status: Recruiting
• Phase: Phase 2
• Start date: March 18, 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: Yanli Wang
• Phone: 010-67519614
• Email: wangyanli[@]staidson.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 18 =age=70 years of age,male.

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:

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 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.

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The first hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Fujian Medical University Affiliated Union Medical College Hospital	Fuzhou	Fujian
China	Southern Medical University Southern Hospital	Guangzhou	Guangdong
China	Guizhou Medical University Affiliated Hospital	Guiyang	Guizhou
China	Harbin First Hospital Hematology Tumor Research Center	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Lanzhou University First Hospital	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing University School of Medicine Affiliated Gulou Hospital	Nanjing	Jiangsu
China	Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shengjing Hospital Affiliated to China Medical University	Shenyang	Liaoning
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	Hospital of Hematology, Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Xi'an Central Hospital	Xi'an	Shanxi
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Within 3 months after enrollment
Primary	Proportion of successfully treated bleeding episodes		12 hours after first administration of study drug
Secondary	Proportion of successfully treated bleeding episodes		8 hours after first administration of study drug
Secondary	Proportion of bleeding episodes received salvage treatment		Within 3 months after enrollment