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
Qualifiers
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
Treatments tested in this trial
- STSP-0601 for Injection
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov