NCT03947567招募中4 期
A Multicenter, Open, Extension Trial to Evaluate Safety and Efficacy of Recombinant Human Coagulation Factor VIII (SCT800) During Long Term Treatment in Previously Treated Patients With Severe Haemophilia A .
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Incidence of FVIII inhibitors
研究概览
简要总结
This study is a multi-center, open-label, extension trial to evaluate the safety, efficacy of SCT800 in long term prophylaxis and on-demand treatment in patients with severe hemophilia A who have been previously treated with coagulation factor VIII(FVIII) . This study includes two phases: the screening period and prophylaxis period.Prophylaxis with 25 - 50 IU/kg of SCT800 shall be administered once every other day or three times per week starting from V1, on-demand treatment is given when bleeding episodes occur. The study period is 120 consecutive weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients who are diagnosed with severe (laboratory tested FVIII:C <2%) hemophilia A;
- •Patients Who Completed trial of SCT800-A302 or SCT800-A 303 and New PTP(previously treated patients)(Previously received FVIII prophylactic or bleeding treatment, have the relevant records and are verified to have accumulated exposures days( EDs) ≥150 days;
- •Negative FVIII inhibitor assay results (laboratory tested Nijmegen-Bethesda assay result <0.6 BU(Bethesda unit)/mL);
- •The treatment records of at least 50EDs before screening can be obtained;
- •HIV negative; if HIV positive, the viral load <200 particles/uL or <400,000 copies/mL, and HIV patients must satisfy CD4+ count >200/μL;
- •The patient or his guardian voluntarily signed the Informed Consent Form.
排除标准
- •Known allergy to any coagulation factor VIII or any excipient; known allergy to bovine, rodent or hamster bovine;
- •Has a history or family history of blood coagulation factor VIII inhibitor;
- •Patients with other coagulation dysfunction diseases in addition to hemophilia A;
- •Patients with other clinically significant diseases, alcoholism, drug abuse, mental disorders or intellectual disabilities;
- •Patients with other severe or clinical significant diseases verified by the investigator to be unable to benefit from the clinical study;
- •Patients who participated in other clinical studies within one month before the first drug administration (except FVIII trials) and patients who participated in other FVIII clinical trials after signing the Informed Consent Form;
研究组 & 干预措施
Recombinant Human Coagulation FVIII
Experimental
干预措施: Recombinant Human Coagulation FVIII (Drug)
结局指标
主要结局
Incidence of FVIII inhibitors
时间窗: up to 120 weeks
The Nijmegen-Bethesda assay shall be used to monitor the production of FVIII inhibitors during the trial.
次要结局
- Annualized Bleeding Rate(up to 120 weeks)
- FVIII incremental in-vivo recovery(up to 120 weeks)
- Bleeding event treatment efficacy(up to 120 weeks)
研究者
研究点 (1)
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