Phase III Clinical Trial of STSP-0601 for Injection in Hemophilia Patients
ConditionHemophilia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-70
SponsorJiangsu BioJeTay Biotechnology Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
12 ≤age≤70 years of age.
Hemophilia A or B patients.
Peak historical inhibitor titer ≥ 5 BU and a positive inhibitor test when enrolled.
Establish proper venous access.
Disqualifiers
Have any coagulation disorder other than hemophilia.
Plan to receive prophylactic treatment of coagulation factor during the trail.
Patients plan to receive Emicizumab during the trial.
Patients received anticoagulant or antifibrinolytic therapy 7 days before the first administration or plan to receive these drugs during the trial.
Trial design
Design model
Single group
Treatments tested in this trial
STSP-0601 for Injection
DrugEvaluation 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
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Continuous administration of STSP-0601Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
12 hours effective hemostasis rate
Time frame
12 hours after the first administrationSecondary outcomes
1
Effective hemostasis rate at the first 12 hours bleeding visit
Time frame
12 hours after the first administration2
12 hours excellent + good rate
Time frame
12 hours after the first administration3
The number of medication required for effective hemostasis within 12 hours
Time frame
12 hours after the first administration4
The amount of medication (U/kg) required for effective hemostasis within 12 hours
Time frame
12 hours after the first administrationSponsors and contacts
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Source ClinicalTrials.gov