NCT02921945Unknown3 期
A Multi-center, Phase III, Non-controlled, Open-label Trial to Evaluate the Safety and Efficacy of SCT800 for On-demand Treatment in Previously Treated Patients With Hemophilia A
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incremental Recovery (K-value)
研究概览
简要总结
In this trial safety and efficacy of SCT800 (B-domain deleted recombinant factor VIII) is being evaluated in 50 subjects, 12 to 65 years of age, with moderate to severe Hemophilia A. These subjects will receive open label treatment with SCT800 for approximately 6 months for on-demand treatment.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 to 65 years old;
- •The activity of the coagulation factor VIII (FVIII:C) ≤5%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
- •Bleeding state need to be treated with FVIII;
- •Negative assays for FVIII inhibitors (<0.6 BU/mL);
- •The platelet count is normal；
- •Normal prothrombin time or INR ≤1.5；
- •Given informed consent
排除标准
- •Hypersensitivity to recombinant coagulation factor VIII concentrate or any of the excipients ;allergic to heterologous proteins (e.g. murine, bovine or hamster origin);
- •Family history or history of FVIII inhibitors (≥0.6 Bethesda Units [BU] mL-1);
- •Received an infusion of any FVIII for on-demand therapy or prophylaxis within 4 days prior to study entry (including rFVIII, plasma-derived factor VIII [pdFVIII], cryoprecipitate and whole blood);
- •Significant hepatic or renal impairment (ALT and AST ≥2×ULN; BUN and Cr≥2×ULN);
- •HIV seropositive;
- •Abnormal hemostasis from causes other than hemophilia A；
- •Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level);
- •Patients who received any anticoagulant or antiplatelet therapy within one week (including NSAIDs) or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials;
- •Alcoholism, drug abuse, mental disorders and mental retardation;
- •Elective surgery planned during the process of study;
- •Patients who previously participated in the other clinical trials prior to study entry;
- •The patient or parent/legal guardian is unable or unwilling to sign an informed consent form or to comply with the requirements of clinical protocol;
- •Other conditions confirmed by the researchers, resulting in that patients are unable to benefit from clinical observation;
结局指标
主要结局
Incremental Recovery (K-value)
时间窗: 1hour after the end of the infusion
One-stage aPTT Assay
次要结局
- Haemostatic effect of SCT800 evaluated according to a predefined four grade scale: excellent, good, moderate, or no response(Up to 6 months)
- The incidence rate of FVIII inhibitors (≥0.6 BU)(Up to 6 months)
- The number of infusions of SCT800 required per bleeding episode(Up to 6 months)
- Actual consumption of SCT800 (IU/Kg/bleed)(Up to 6 months)
- AEs related to SCT800 during the clinical study(Up to 6 months)
研究者
研究点 (1)
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