CTIS2023-508929-27-00进行中（未招募）1 期
A Phase 3 open-label, multicenter study of the long-term safety and efficacy of intravenous recombinant coagulation factor VIII Fc-von willebrand factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN; BIVV001) in previously treated patients with severe hemophilia A - LTS16294
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 272
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •For participants rolling over into Arm A • Participants who have completed the studies EFC16923, EFC16925, Arm B or Arm C of the current study, or any other potential BIVV001 study., For participants rolling over into Arm A: • Male or Female, For participants new to BIVV001 (Arm B and C) • Participants who have 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., For participants new to BIVV001 (Arm B and C) • Previous treatment for hemophilia A (prophylaxis or on-demand) with any recombinant and/or plasma-derived FVIII, or cryoprecipitate for at least 150 EDs or 50 EDs for participants aged <6 years., For participants new to BIVV001 (Arm B and C) • Platelet count =100 000 cells/µL at screening., For participants new to BIVV001 (Arm B and C) • A participant known to be human immunodeficiency virus (HIV) antibody positive, either previously documented or identified from screening assessments, must have the following results prior to enrollment: CD4 lymphocyte count >200 cells/mm³ and viral load of <400 000 copies/mL, For participants new to BIVV001 (Arm B and C) • Male, For participants new to BIVV001 (Arm B and C) • Only for Arm B: Chinese participants, For participants new to BIVV001 (Arm B and C) • Only for Arm C: planned major surgery within 6 months after Day 1.
排除标准
- •For participants rolling over into Arm A • Positive inhibitor result, defined as =0.6 Bethesda units (BU)/mL, For participants new to BIVV001 (Arm B and Arm C) • Treatment with NSAIDs greater than the maximum dose specified in the regional prescribing information within 2 weeks prior to screening., For participants new to BIVV001 (Arm B and Arm C) • Systemic treatment within 12 weeks prior to Screening with chemotherapy and/or other immunosuppressive drugs (except for the treatment of hepatitis C virus [HCV] or HIV)., For participants new to BIVV001 (Arm B and Arm C) • Emicizumab use within the 20 weeks prior to screening., For participants new to BIVV001 (Arm B and Arm C) • Major surgery within 8 weeks prior to screening., For participants rolling over into Arm A • Participation in another study., For participants new to BIVV001 (Arm B and Arm C) • Any concurrent clinically significant liver disease that, in the opinion of the Investigator, would make the participant unsuitable for enrollment. This may include, but is not limited to cirrhosis, portal hypertension, and acute hepatitis., For participants new to BIVV001 (Arm B and Arm C) • Serious active bacterial, fungal, or viral infection (other than chronic hepatitis or HIV) present within 30 days of screening., For participants new to BIVV001 (Arm B and Arm C) Other known coagulation disorder(s) in addition to hemophilia A., For participants new to BIVV001 (Arm B and Arm C) • History of hypersensitivity or anaphylaxis associated with any FVIII product., For participants new to BIVV001 (Arm B and Arm C) • History of a positive inhibitor (to FVIII) test defined as =0.6 BU/mL, or any value greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL, or clinical signs or symptoms of decreased response to FVIII administrations. Family history of inhibitors will not exclude the participant., For participants new to BIVV001 (Arm B and Arm C) • Positive inhibitor test (FVIII) result, defined as =0.6 BU/mL at screening., For participants new to BIVV001 (Arm B and Arm C) • Treatment with acetylsalicylic acid (ASA) or antiplatelet agents that are not nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to screening.
研究者
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