ACTRN12620001152910已完成1 期
Pharmacokinetic Evaluation of Coagulation Factor VIIa (Recombinant) in Subjects with Congenital Hemophilia A with or without Inhibitors to Factor VIII
FB USA, Inc.0 个研究点目标入组 28 人开始时间: 2020年11月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- Male
入选标准
- •1. Have the ability to provide informed consent, including privacy authorization, before study participation
- •2. Be judged by the investigator as willing and able to comply with the study procedures and visit schedules
- •3. Be a male, aged 18 to 75 years, inclusive, at the time of informed consent
- •4. Have a confirmed diagnosis of congenital hemophilia A (with or without inhibitors to FVIII) of any severity and not be experiencing an active bleeding episode
- •5. If enrolled with a medical history of inhibitors to FVIII, have a positive inhibitor test result (5 Bethesda Units (BU) and above) at the local laboratory during the 14 day screening period
排除标准
- •1. Have any other known coagulation or hematologic disorder(s) or condition(s) in addition to hemophilia A
- •2. Be immunosuppressed (i.e., the patient may not be receiving systemic immunosuppressive medication; cluster of differentiation 4 (CD4) counts at screening must be >200/µL)
- •3. Have undergone a major surgical procedure (e.g., orthopedic, abdominal) within 1 month
- •before administration of LR769
- •4. Be currently receiving treatment for active, ongoing bleeding, or if treatment for a bleeding was stopped within 24 hours of the time of LR769 administration
- •5. Have a medical history of malignancy within the past 5 years (except for nonmelanoma
- •skin cancer)
- •6. Have a clinically significant cardiac arrhythmia/dysrhythmia or unstable cardiac disease,
- •based on medication use, recent (< 6 months) medical history or intervention, or ECG
- •results during screening
- •7. Have positive serology during the 14 day screening period for hepatitis B (hepatitis B
- •surface antigen), hepatitis C virus (except patients with history of cured Hepatitis C proven
- •by a documented HCV RNA negative RT-PCR performed at least 24 weeks after completion of the Hepatitis C treatment, and with normal liver function tests), or human
- •immunodeficiency virus
- •8. Be currently taking or have taken within 7 days prior to LR769 administration (Day 1) known or suspected anticoagulants, antiplatelet medications, supplements, dietary ingredients, or other medications that may alter platelet aggregation including, but not limited to, the following:
- •Nonsteroidal anti-inflammatory drugs (commonly known as NSAIDs)
- •Herbal or natural medications
- •Supplements or vitamins
- •Other platelet-inhibiting drugs
- •9. Have any life-threatening disease, or other disease or condition that, in the investigator’s judgment, could pose a potential hazard to the subject or interfere with study participation or study outcome (e.g., a history of no response to bypassing products or thromboembolic disease)
- •10. Have any known or suspected hypersensitivity to the active substance in LR769 or to any of its excipients
- •11. Have any known or suspected allergy or hypersensitivity to rabbits or rabbit proteins
- •12. Have received a Factor VII- or FVIIa-containing product (either plasma derived or recombinant) within 24 hours prior to administration of LR769
- •13. Have received an investigational drug within 30 days prior to LR769 administration, or be expected to receive such drug during participation in this study
- •14. Have platelet count <100,000/µL
- •15. Have abnormal renal or hepatic function as defined by the following laboratory results at screening:
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN)
- •Serum creatinine concentration >2 times the
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