EUCTR2017-000373-36-Outside-EU/EEA进行中（未招募）1 期
A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects with Inhibitors Undergoing the First ITI Treatment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- Male
入选标准
- •1.Ability of the subject or his legally authorized representative (e.g., parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
- •2.Male subjects of any age diagnosed with severe hemophilia A (as confirmed from the medical record).
- •3. Currently diagnosed with high titer inhibitors (historical peak =5 BU/mL, according to medical records)
- •4.Previously treated with any plasma-derived or recombinant conventional or Extended Half-Life FVIII.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 17
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Other coagulation disorder(s) in addition to hemophilia A.
- •2. Previous ITI
- •3. History of hypersensitivity or anaphylaxis associated with any rFVIIIFc administration.
- •4. Planned major surgery scheduled during the study unless deferred until after study completion (minor surgery such as tooth extraction or insertion/replacement of central venous access device is allowed)
- •5. Abnormal renal function (serum creatinine >1.5 mg/dL or 2x upper limit of normal (ULN) for subject age based on local laboratory range) as assessed by local laboratory.
- •6. Serum alanine aminotransferase or aspartate aminotransferase >5 × upper limit of normal (ULN) as assessed by local laboratory.
- •7. Serum total bilirubin >3 × ULN as assessed by local laboratory
- •8. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy, other than rFVIIIFc, for investigational use is administered within 30 days (or 5 half-lives of the agent, whichever is longer) prior to the Baseline Visit.
- •9. Inability to comply with study requirements.
- •10. Presence of any medical or psychological condition or laboratory result that in the opinion of the Investigator can interfere with the subject’s ability to comply with the protocol requirements or make the subject not appropriate for inclusion to the study and treatment with Elocta/Eloctate (rFVIIIFc)
- •11. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment.
- •12. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that prevents the subject from participating in visits as scheduled or entering required information into the EPD in a timely manner
- •13. Concurrent systemic treatment with immunosuppressive drugs within 12 weeks (3 months) prior to Screening. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days within 12 weeks [3 months] prior to Day 1) and/or inhaled steroids
- •14. High risk of cardiovascular, cerebrovascular, or other thromboembolic events, as judged by the Investigator
- •The following criteria refer to tests performed within 26 weeks (6.5 months) prior to Screening. If not available, a new test will be drawn at the Screening visit.
- •15. Cluster of differentiation 4 (CD4) lymphocytes <200 mm3 at Screening, if known as human immunodeficiency virus (HIV) antibody positive based on medical history or HIV testing
- •16. Viral load of >400 copies/mL at Screening, if known as HIV antibody positive, based on medical history.
研究者
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