CTRI/2018/06/014682进行中（未招募）3 期
ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX
试验速览
- 阶段
- 3 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
入排标准
入选标准
- •1. Males, >=12 years of age
- •2. Severe hemophilia A or B with inhibitors
- •â?¦(Severity confirmed by a central laboratory where FVIII level is <1% or FIX level is <=2% at Screening; Inhibitors defined as inhibitor titer of >=0.6 BU/mL or as evidenced by medical records)
- •3. A minimum of 6 bleeding episodes requiring bypassing agent treatment within the last 6 months prior to Screening
- •4. Willing and able to comply with the study requirements and to provide written informed consent and assent
排除标准
- •1. Known co-existing bleeding disorders other than hemophilia A or B
- •2. Antithrombin (AT) activity <60% at Screening
- •3. Co-existing thrombophilic disorder
- •4. Clinically significant liver disease
- •5. Active HCV infection
- •6. HIV positive with a CD4 count of <200 cells/μL
- •7. History of arterial or venous thromboembolism
- •8. Inadequate renal function
- •9. History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine (GalNAc)
- •10. History of intolerance to SC injection(s)
- •11. Any other conditions or comorbidities that would make the patient unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement
研究者
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