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

Staidson (Beijing) Biopharmaceuticals Co., Ltd12 sites in 1 country32 target enrollmentJanuary 9, 2023

ConditionsHemophilia

InterventionsSTSP-0601 for Injection

DrugsSTSP-0601 for Injection

Overview

Phase: Phase 2
Intervention: STSP-0601 for Injection
Conditions: Hemophilia
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Enrollment: 32
Locations: 12
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 9, 2023

End Date

August 25, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

Consecutive doses of low-dose of STSP-0601

Intervention: STSP-0601 for Injection

Consecutive doses of high-dose of STSP-0601

Intervention: STSP-0601 for Injection

Outcomes

Primary Outcomes

Incidence of adverse events

Time Frame: From day 0 to up to day 4

Proportion of successfully treated bleeding episodes

Time Frame: 8 hours after first administration of study drug

Secondary Outcomes

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)