Hemophilia
Conditions
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.
Interventions
Intravenous Injection
Sponsors
Beijing Novikang Medical Technology Co., LTD
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | From day 0 to up to day 4 |
| Proportion of successfully treated bleeding episodes | 8 hours after first administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed