EUCTR2016-001463-36-DK进行中（未招募）1 期
ATLAS-INH: A Phase 3 study to evaluate the efficacy and safety of fitusiran (ALN-AT3SC) in patients with hemophilia A or B, with inhibitory antibodies to factor VIII or IX
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- •Males =12 years of age. In Denmark only males = 18 years of age.
- •Severe hemophilia A or B with inhibitors evidenced by:
- •a.A central laboratory measurement or documented medical record
- •evidence of FVIII <1% or FIX level =2% at Screening.
- •b.On-demand use of BPAs to manage bleeding episodes for at least the
- •last 6 months prior to Screening, and meet one of the following
- •Nijmegen-modified Bethesda assay results criteria:
- •Inhibitor titer of =0.6 BU/mL at Screening, or
- •Inhibitor titer of <0.6 BU/mL at Screening with medical record evidence
- •of 2 consecutive titers =0.6 BU/mL, or Inhibitor titer of <0.6 BU/mL at Screening with medical record evidence
- •of anamnestic response
- •A minimum of 6 bleeding episodes requiring BPA treatment within the
- •last 6 months prior to Screening.
- •Willing and able to comply with the study requirements and to provide
- •written informed consent and assent in the case of patients under the
- •age of legal consent, per local and national requirements. Assent is N/A in Denmark as only patients = 18 years of age will be included.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with known co-existing bleeding disorders other than
- •hemophilia A or B
- •Patients with clinically significant liver disease
- •Patients known to be HIV positive and have a CD4 count <200 cells/µL
- •Patients with a history of arterial or venous thromboembolism
- •Estimated glomerular filtration rate =45 mL/min/1.73m2 (using the
- •Modification of Diet in Renal Disease [MDRD] formula)
- •Patients with a co-existing thrombophilic disorder
- •Patients with a history of multiple drug allergies or history of allergic
- •reaction to an oligonucleotide or GalNAc
- •Patients with a history of intolerance to SC injection(s)
- •Patients with an anticipated or planned need for surgery during the
- •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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