NCT05777993Enrolling By Invitation4 期
A Rollover Study to Provide Continued Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 59
- 试验地点
- 23
- 主要终点
- Not applicable as this protocol is to provide an option for continued access to mitapivat for participants who have previously participated in an Agios-sponsored mitapivat study
研究概览
简要总结
The primary objective of the study is to provide continued access to participants who are deriving clinical benefit from ongoing mitapivat treatment in an Agios-sponsored mitapivat study, in the opinion of the Investigator.
详细描述
Participants will continue the mitapivat dose regimen that they were receiving at the final visit of their antecedent study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participating in an Agios-sponsored study of mitapivat and deriving clinical benefit from ongoing mitapivat treatment, in the opinion of the Investigator.
- •For women of childbearing potential (WOCBP), must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use 2 forms of contraception, 1 of which must be considered highly effective, from the time of providing informed consent/assent, throughout the study, and for 28 days after the last dose of study drug. The second form of contraception can be an acceptable barrier method.
- •Written informed consent/assent from the participant (or their legally authorized representative, parent[s], or legal guardian) before any study-related procedures are conducted, and participants must be willing to comply with all study procedures for the duration of the study.
- •Agrees not to participate in other interventional clinical studies, including other studies of mitapivat, during participation in this study.
排除标准
- •Known allergy or other contraindication to mitapivat or its inactive ingredients as defined in the current investigator brochure (IB).
- •Any medical, hematologic, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data. Also excluded are:
- •Participants who are institutionalized by regulatory or court order.
- •Participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the Investigator or Sponsor).
研究组 & 干预措施
Mitapivat
Experimental
Participants will continue to receive mitapivat at the same dose regimen they were receiving at the final visit of their antecedent study.
干预措施: Mitapivat (Drug)
结局指标
主要结局
Not applicable as this protocol is to provide an option for continued access to mitapivat for participants who have previously participated in an Agios-sponsored mitapivat study
时间窗: Not Applicable - Study Completion
次要结局
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to approximately 6.2 years)
- Percentage of Participants With AEs and SAEs, Graded by Severity(Up to approximately 6.2 years)
- Percentage of Participants With AEs Considered by the Investigator to be Related to Study Drug(Up to approximately 6.2 years)
- Percentage of Participants With SAEs Considered by the Investigator to be Related to Study Drug(Up to approximately 6.2 years)
研究者
研究点 (23)
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