EUCTR2018-002880-25-DK进行中（未招募）1 期
ATLAS-OLE: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients with Hemophilia A or B, with or without Inhibitory Antibodies to Factor VIII or IX - ATLAS-OLE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 244
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •01. Participant must be at least 12 years of age inclusive, at the time of signing the informed consent
- •Type of participant and disease characteristics
- •02. Participants with severe hemophilia A or B who have completed a Phase 3 fitusiran clinical trial
- •A) There are no contraceptive requirements for this study except where required by local regulations.
- •Informed Consent
- •04. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in
- •this protocol. In countries where legal age of majority is above 18 years, a specific ICF must also be signed by the participant’s legally authorized representative.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 22
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical conditions
- •01. Completion of a surgical procedure within 14 days prior to screening, or currently receiving additional factor concentrate or BPA infusion for postoperative hemostasis
- •Prior/concomitant therapy
- •02. Current participation in ITI
- •03. Current use of factor concentrates or BPAs as regularly administered prophylaxis designed to prevent spontaneous bleeding episodes. However, participants requiring factor concentrates or BAs prophylaxis during the study dosing pause period, per Investigator's judgement in agreement with the study Medical Monitor may be permitted to be enrolled.
- •04. Use of compounds other than factor concentrates or BPAs for hemophilia treatment, including use of emicizumab (Hemlibra®) within 6 months prior to screening.
- •Prior/concurrent clinical study experience
- •05. Received an investigational drug or device, other than fitusiran, within 30 days of anticipated IMP administration or 5 half-lives of the IMP, whichever is longer
- •06. Current or prior participation in a gene therapy trial
- •Diagnostic assessments
- •07. ALT and/or AST >1.5× upper limit of normal reference range (ULN) for patients who are naïve to fitusiran at study start; ALT and/or AST >5× ULN for patients who were in the fitusiran arm in the parent study.
- •Other exclusions
- •08. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
- •09. Any country-related specific regulation that would prevent the participant from entering the study
- •10. Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures
- •11. Participants who are dependent on the Sponsor or Investigator (as defined in section 1.61 of the International Council for Harmonisation (ICH)-Good Clinical Practice (GCP) E6)
- •12. Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
- •13. Any specific situation during study implementation/course that may rise ethics considerations
- •14. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
研究者
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