Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients

Sponsor
Jiangsu BioJeTay Biotechnology Co., Ltd.
Study ID
NCT06922045
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • STSP-0601 for Injection — DRUG
    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

Study Details

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

Key Dates

Start date
Mar 26, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Continuous administration of STSP-0601

Primary Outcome Measure

12 hours effective hemostasis rate [ Time Frame: 12 hours after the first administration ]

Central Contacts

Related Studies