NCT02888223Unknown1 期
Pharmacokinetic Comparison of SCT800 (B-domain Deleted Recombinant Factor VIII) With Xyntha in Previously Treated Patients With Hemophilia A: a Phase I, Open-label, Randomized, Crossover Study
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Factor VIII (FVIII) Clearance (CL)
研究概览
简要总结
Participants will be assigned to A or B groups with a scale of 1:1 based on a prospectively randomized treatment-sequence assignment, i.e. infuse SCT800 followed by Xyntha (group A), or the alternate sequence (group B). All participants who completed the SCT800HA1 study will enter the efficacy and safety study (Protocol No.: SCT800HA3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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) ≤2%, and was previously treated with FVIII concentrate(s) for a minimum of 50 exposure days (EDs) prior to study entry
- •Non-bleeding state (No clinical manifestations of active hemorrhage);
- •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
Factor VIII (FVIII) Clearance (CL)
时间窗: 48 hours after the end of the infusion
One-stage aPTT Assay
Incremental Recovery (K-value)
时间窗: 1hour after the end of the infusion
One-stage aPTT Assay
Elimination Phase Half-life (t1/2)
时间窗: 48 hours after the end of the infusion
One-stage aPTT Assay
Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUClast)
时间窗: 48 hours after the end of the infusion
One-stage aPTT Assay
次要结局
- Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC∞)(48 hours after the end of the infusion)
- FVIII Maximum Plasma Concentration (Cmax)(3 hours after the end of the infusion)
- Volume of Distribution at Steady State (Vss)(48 hours after the end of the infusion)
- AEs related to SCT800 during treatment and observation of the clinical study(48 hours after the end of the infusion)
- Mean Residence Time (MRT)(48 hours after the end of the infusion)
- Incidence of inhibitors(72 hours after the end of the infusion)
研究者
研究点 (1)
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