JPRN-jRCT2031230034
尚未招募
4 期
A Rollover Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study - AG348-C-025
ishioka Tsuyoshi0 个研究点目标入组 4 人2023年4月17日
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Pyruvate Kinase Deficiency
- 发起方
- ishioka Tsuyoshi
- 入组人数
- 4
- 状态
- 尚未招募
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Has completed an Agios\-sponsored adult pyruvate kinase (PK) deficiency study of mitapivat within 1 day of enrollment in this rollover study;
- •\- Is unable to obtain mitapivat treatment due to country regulations or lack of commercial access;
- •\- Was deriving clinical benefit from mitapivat treatment at the completion of the antecedent study, in the opinion of the Investigator;
- •\- For women of childbearing potential, 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, 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 from the participant before any study\-related procedures are conducted and 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
- •\- Has discontinued treatment with mitapivat before completing the antecedent study;
- •\- Known allergy or other contraindication to mitapivat or its inactive ingredients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, Opadry II Blue \[hypromellose, titanium dioxide, lactose monohydrate, triacetin, and FD\&C Blue \#2]);
- •\- 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 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).
结局指标
主要结局
未指定
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