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

Phase 2

Completed

• Conditions: Hemophilia
• Interventions: Drug: STSP-0601 for Injection

• Registration Number: NCT05619926
• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-17
• Study Start: 2023-01-09
• Status Verified: 2023-08
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Last Update Submitted: 2023-12-29
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Consecutive doses of low-dose of STSP-0601	STSP-0601 for Injection	-
Consecutive doses of high-dose of STSP-0601	STSP-0601 for Injection	-

Primary Outcome Measures

Name	Time	Method
Proportion of successfully treated bleeding episodes	8 hours after first administration of study drug
Incidence of adverse events	From day 0 to up to day 4

Secondary Outcome Measures

Name	Time	Method
Proportion of successfully treated bleeding episodes	12 hours，24 hours after first administration of study drug
Proportion of bleeding episodes received salvage treatment	Within 3 months after enrollment

Trial Locations

Locations (12)

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Lanzhou University First Hospita; 🇨🇳 Lanzhou, Gansu, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

North China University of Technology Affiliated Hospital; 🇨🇳 Tangshan, Hebei, China

The First Affiliated Hospital of Nanyang Medical College; 🇨🇳 Nanyang, Henan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Nanjing Gulou Hospital; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Xi'an Central Hospital; 🇨🇳 Xi'an, Shanxi, China

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