EUCTR2018-002880-25-DE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
适应症
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
- •04. Use of compounds other than factor concentrates or BPAs for hemophilia treatment
- •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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