NCT05487976Unknown3 期
A Phase III Clinical Study of the Efficacy and Safety of Recombinant Human Activated Coagulation Factor VII for Injection in Patients With Hemophilia With Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Number of bleeding Effective rate of hemostasis
研究概览
简要总结
Human coagulation factor VII is a vitamin K-dependent serine endogenous protease, and its activated form plays an important role in the coagulation process. Recombinant human activated coagulation factor VII is an activated state coagulation factor VII obtained by recombinant means.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 Diagnosed as congenital hemophilia A or B, and meet the following conditions:
- •FⅧ<1% or FIX activity<2%;
- •FⅧ inhibitor or FⅨ inhibitor titer in the screening period>5 BU (Nijmegen modified Bethesda method of detection)."
- •2 Age ≥18 and ≤65 years, male or female.
- •3 There have been at least two incidents of bleeding of any kind in the last six months.
- •4 No other drugs for the treatment of hemophilia have been used within 72hours (3 days) before administration, including prothrombin complex and any coagulation factor VII or activated coagulation factor VII、coagulation factor VIII、coagulation factor IX products, cryoprecipitate, fresh plasma and whole blood, etc.
- •5 Subjects of childbearing age agree to take effective contraceptive measures throughout the trial period, and continue to 28 days after the last medication.
- •6 Volunteer to participate in this study, sign an informed consent form, have good compliance, and be able to cooperate with the experimental observation.
排除标准
- •1 Any other bleeding disease except Congenital hemophilia A or B.
- •2 Patients with any previous medical history or symptoms of arterial or venous thromboembolic events (such as atherosclerosis, myocardial infarction, ischemic stroke, transient ischemic attack, deep vein thrombosis or pulmonary hypertension embolism) or disseminated intravascular coagulation (DIC) within the past 1 year.
- •3 Baseline and previous values of FⅦ inhibitor or activated recombinant human coagulation factor VII inhibitor is positive.
- •4 Vitamin K deficiency.
- •5 Human immunodeficiency virus (HIV) positive and cluster of differentiation 4 (CD4) count ≤200/μl, the number of virus carriers ≥200 particles/μl or ≥400000 copies/ml.
- •6 Subjects plan to perform elective surgery during the trial period.
- •7 Those who are allergic to test drugs or any excipients.
- •8 Severe anemia and need blood transfusion.
- •9 Platelet count <80×10^9/L.
- •10 Obvious liver or kidney damage: glutamic-pyruvic transaminase (ALT) or aspartic transaminase (AST)>2.5×ULN, or total bilirubin>1.5×ULN or serum creatinine>1.5×ULN.
- •11 Severe heart disease, including myocardial infarction, cardiac insufficiency grade 3 or above, the current New York Heart Association cardiac function grade II-IV.
- •12 There was a prior intracranial hemorrhage
- •13 Those who had used or planned to use any anticoagulants, antifibrinants and drugs affecting platelet function during the first week of medication included non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin
- •14 Hypertension that cannot be controlled with drug treatment: systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg.
- •15 Participated in other clinical studies (except Activated coagulation factor VII, coagulation factor VIII and coagulation factor IX trials) within one month before the first medication.
- •16 Alcoholism, drug abuse, mental disorders, other severe acute or chronic diseases, greater abnormal laboratory values, and those who are considered unsuitable by the researcher.
研究组 & 干预措施
Recombinant human activated coagulation factor VII for injection
Experimental
Each subject in this study received on-demand treatment with recombinant human activated coagulation factor VII for injection for 24 weeks. The single dose for each bleeding event was 90 μg/kg, and the number of doses was increased according to the remission after treatment.
干预措施: Recombinant human activated coagulation factor VII for injection (Drug)
结局指标
主要结局
Number of bleeding Effective rate of hemostasis
时间窗: Each new blood event was assessed within 12 hours of initial treatment
Hemostasis is effective after the bleeding event if the bleeding event has not received other treatment within 12 hours since the first treatment and achieved moderate or above remission (based on the four-point scoring standard)
Activity recovery of first dose
时间窗: Within 1 hour of completion of infusion
The peak coagulation factor VII activity measured within 1 hour after the end of the infusion was subtracted from the baseline coagulation factor VII activity and expressed as \[IU/ml\]/\[IU/kg\].
次要结局
- Number of bleeding effective rate of hemostasis within 8 hours(Each new blood event was assessed within 8 hours of initial treatment)
- Number of bleeding effective rate continuous hemostatic(Each new blood event was assessed within 24 hours of initial treatment)
- Number of injections for each new blood transfusion(Up to 24 weeks.)
- Activity recovery after repeated administration(Within 1 hour of completion of infusion)
- Dose of injections for each new blood transfusion(Up to 24 weeks.)
- Coagulation tests(First and week 24，within 30 minutes before the administration and 5 minutes after the completion of drug injection.)
研究者
研究点 (9)
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