NCT06137092已完成3 期
A Randomized, Two-armed, Double-blind, Single-dose, Crossover, Two-sequence, Bioequivalence Clinical Trial to Compare PK Parameters and Safety of rFVIII-Fc (AryoGen Pharmed Co.) Versus Elocta® in PTPs With Severe Hemophilia A
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- dose-normalized Area Under the Curve (dnAUC last)
研究概览
简要总结
The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve (dnAUC last)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients ≥ 12 years, with signed informed consent by the patient, or the patient's legally authorized representative for patients under the legal age
- •Diagnosed with severe hemophilia A (endogenous FVIII <1% [1 IU/dL])
- •History of at least 150 documented prior exposure days to any FVIII product
- •Having adequate bone marrow and organ function:
- •Plt ≥ 80,000 cells/µL
- •Hb ≥ 8 mg/dL
- •eGFR ≥ 30 mL/min
- •ALT or AST ≤ 5×ULN
- •Serum bilirubin ≤ 1.5×ULN
排除标准
- •Measurable anti-drug antibody activity against FVIII (≥ 0.6 BU/mL) at screening or a history of developing anti FVIII antibody
- •History of other coagulation disorders except for hemophilia A
- •Acute hemorrhagic state
- •Infection with HCV or HBV
- •HIV-positive patients
- •Infusion of any products containing FVIII within 7 days prior to first administration
- •Previous treatment with commercially available extended half-life FVIII products
- •Receiving drugs which increase bleeding tendency (e.g: Anti-coagulants, antiplatelets, omega 3, Vit E, etc.) within 2 weeks of screening. NSAIDs are permitted.
- •Current systemic treatment with immunosuppressive drugs
- •Hypersensitivity or anaphylaxis associated with any FVIII concentrate or intravenous immunoglobulin (IVIG)
- •Planned elective surgery
- •Current enrolment or willing to enroll in any other experimental study during the time of current trial
- •Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g.: physical, psychological and mental problems)
研究组 & 干预措施
AryoGen Pharmed Co. rFVIII-Fc/Elocta® (Sobi Co. rFVIII-Fc)
Experimental
AryoGen Pharmed Co. rFVIII-Fc, IV, 50 units/kg, single dose, then Elocta® (Sobi Co. rFVIII-Fc), IV, 50 units/kg, single dose (cross-over)
干预措施: Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) (Drug)
Elocta® (Sobi Co. rFVIII-Fc)/AryoGen Pharmed Co. rFVIII-Fc
Experimental
Elocta® (Sobi Co. rFVIII-Fc), IV, 50 units/kg, single dose, then AryoGen Pharmed Co. rFVIII-Fc, IV, 50 units/kg, single dose (cross-over)
干预措施: Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) (Drug)
结局指标
主要结局
dose-normalized Area Under the Curve (dnAUC last)
时间窗: pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose
Area under the concentration-time curve measured from the time of administration to the last measurable time point
次要结局
- Area Under the Curve to Infinity (AUC inf)(pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose)
- Volume of distribution (Vd)(pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose)
- Immunogenicity assessment(Immunogenicity sampling was done at screening visit and day 7, 12 and 28)
- Incremental Recovery (IR)(pre-dose, 15 minutes, 30 minutes, 1 hour)
- Maximum Plasma Activity (Cmax)(pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose)
- Half-life (T ½)(pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose)
- Clearance (Cl)(pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose)
- Safety assessment by evaluation of adverse events (AEs) and abnormal laboratory results(Adverse events collection and documentation was done during the study (up to 28 days))
研究者
研究点 (5)
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