EUCTR2019-002023-15-IT进行中（未招募）1 期
Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients = or >12 Years of Age With Severe Hemophilia A - XTEND-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participant, male or female, must be equal to or greater than 12 years of age inclusive, at the time of signing the informed consent.
- •2. Severe hemophilia A, defined as <1 IU/dL (<1%) endogenous FVIII activity as documented either by central laboratory testing at Screening or in historical medical records from a clinical laboratory demonstrating
- •<1% FVIII coagulant activity (FVIII:C) or a documented genotype known to produce severe hemophilia A
- •3. Previous treatment for hemophilia A (prophylaxis or on demand) with any recombinant and/or plasma-derived FVIII, or cryoprecipitate for at least 150 EDs.
- •4. Current regimen includes
- •Prophylactic treatment regimen with a FVIII product or prophylactic emicizumab therapy for at least 6 months during the previous 12 months. Appropriate washout time needs to be taken into account.
- •On-demand regimen with a FVIII product with a history of at least 12 bleeding episodes in the previous 12 months or at least 6 bleeding episodes in the previous 6 months prior to study enrollment. On-demand participant is accepting to move to a prophylaxis treatment regimen after 26-week on-demand period.
- •5. Willingness and ability of the participant or surrogate (a caregiver or a family member = or more than 18 years of age) to complete training in the use of the study electronic Patient Diary (ePD) and to use the ePD throughout the study.
- •6. Ability of the participant or his or her legally authorized representative (eg., parent or legal guardian) to understand the purpose
- •and risks of the study, willing and able to comply with study requirements and provide signed and dated informed consent or assent
- •(as applicable) and authorization to use protected health information in accordance with national and local participant privacy regulations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 149
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Clinically significant liver disease.
- •- Serious active bacterial or viral infection (other than chronic hepatitis or HIV) present within 30 days of Screening.
- •- Other known coagulation disorder(s) in addition to hemophilia A.
- •- History of hypersensitivity or anaphylaxis associated with any FVIII product
- •- Positive inhibitor results, defined as = or above 0.6 BU/mL at Screening. History of a positive inhibitor test defined as = or above 0.6 BU/mL. Family history of inhibitors will not exclude the participant.
- •- Use of Emicizumab within the 20 weeks prior to Screening
- •- Major surgery within 8 weeks prior to Screening.
研究者
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