KCT0006060已完成未知
A Phase 1, Open-label, Multi-Center, to investigate Safety, Efficacy, and Pharmacokinetics (PK) of PGA40 in Previously Treated Subjects with Severe Hemophilia A
PanGen Biotech0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 12(Year) 至 65(Year)（—）
- 性别
- Male
入选标准
- •To be eligible for study entry, subjects must satisfy all of the following criteria:
- •1.Male aged = 12 to = 65 years.
- •2.Male subjects with the diagnosis of severe (FVIII:C < 1%)hemophilia documented in medical records.
- •3.Previously treated with plasma-derived and/or recombinant FVIII products for a minimum of 150 EDs (based on the subject’s medical records). Cryoprecipitate and frozen plasma treatment are not considered as a treatment.
- •4.No history of FVIII inhibitors based on the subject’s previous medical records.
- •5.No detectable FVIII inhibitors (=0.6) Bethesda units [BU]) as assessed by a central laboratory at the time of screening.
- •6.Subject who are HIV negative. If, HIV positive viral load < 400.000 copies/mL and CD4+ lymphocyte count ?200/µL at screening
- •7.Subjects who are willing to undergo a prophylactic treatment for at least 50 EDs.
- •8.Non-bleeding state (i.e., no clinical signs of active bleeding) at the time of administration of Investigational product for measurement of recovery in relation to the administration of the first dose and/or at the pharmacokinetic session.
- •9.Subject and/or legal representative has provided signed ICF.
排除标准
- •Subjects will be excluded from the study if one or more of the following criteria are applicable:
- •1.Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII products or hamster protein.
- •2.Previous defined medical record of arterial thrombotic events (i.e. deep vein thrombosis, stroke, pulmonary embolism, myocardial infraction and arterial embolus)
- •3.Abnormal renal function (serum creatinine >2 times the upper limit of normal at screening).
- •4.Active hepatic disease with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 5 times the upper limit of normal at screening.
- •5.Diagnosis of an inherited or acquired hemostatic defect other than hemophilia A.
- •6.Platelet count < 100,000/µL based on medical records and/or based on local laboratory values at screening.
- •7.A clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject’s safety or compliance.
- •8.Patients who are receiving immunotherapy drugs other than chemotherapy, anti-RNA tumor virus chemotherapy, or who use oral or intravenous corticosteroids chronically within 3 months of screening. However, short-term (within 14 days) prednisone / methylprednisolone is allowed for the treatment of diseases such as synovitis and asthma, according to the physician's judgment.
- •9.Use of an investigational medicinal product within 30 days prior to the first PGA40 administration.
- •10.Subjects who received blood transfusions within 30 days of screening.
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