Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B Without Inhibitor

Hemophilia Clinical Trial

Official title:

A Multi-center, Open-label, Multiple-dose Design, Phase 2 Trial to Evaluate the Safety and Efficacy of STSP-0601 for Injection in Patients With Hemophilia Without Inhibitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05619926
• Other study ID #: STSP-0601-03
• Status: Completed
• Phase: Phase 2
• Start date: January 9, 2023
• Est. completion date: August 25, 2023

Study information

• Verified date: August 2023
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the safety,efficacy,pharmacokinetics and pharmacodynamics of multiple-dose of STSP-0601 at two dose levels for the treatment of bleeding episodes in hemophilia A or B patients without inhibitor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 =age=70 years of age,male;

• Hemophilia A or B patients;

• A bleeding event requiring treatment occurred (Only applicable to the on-demand treatment stage);

• Factor VIII or IX level <2%, inhibitor titer < 0.6 BU;

• There were at least 2 bleeding events that requiring treatment occurred in the past 6 months before screening (Only the second stage is applicable);

• Establish proper venous access;

• Agree to use adequate contraception to avoid pregnancy;

• Provide signed informed consent.

Exclusion Criteria:

• Have any coagulation disorder other than hemophilia;

• Plan to receive prophylactic treatment of coagulation factor during the trail;

• 4 weeks before screening, receive prophylactic treatment of amesetuzumab or plan to receive prophylactic treatment of amesetuzumab 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;

• HIV positive;

• Have a known allergy to STSP-0601;

• Participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, FVII, FVIIa, FVIII, FIX trails);

• 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
Intravenous Injection

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Lanzhou University First Hospita	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Gulou Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Nanyang Medical College	Nanyang	Henan
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	North China University of Technology Affiliated Hospital	Tangshan	Hebei
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 (2)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd	Beijing Novikang Medical Technology Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		From day 0 to up to day 4
Primary	Proportion of successfully treated bleeding episodes		8 hours after first administration of study drug
Secondary	Proportion of successfully treated bleeding episodes		12 hours,24 hours after first administration of study drug
Secondary	Proportion of bleeding episodes received salvage treatment		Within 3 months after enrollment