An open-label, multi-centre, rollover study to characterise long-term safety andefficacy of etavopivat in adults, adolescents and children who have sickle cell disease orthalassaemia and have completed a treatment period in an etavopivat study

ovo Nordisk0 个研究点目标入组 325 人开始时间: 2024年7月8日最近更新: 2024年8月19日

适应症

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 325

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 0 Month(s) 至 23 Month(s)（—）
性别: All

入选标准

•1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. United Kingdom: Please see country-specific requirements in Appendix 8
•2. Participant must have ongoing participation in an etavopivat parent study (Table 4-1) for treatment of SCD or thalassaemia and have completed at least a treatment period of the parent study.
•3. Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.
•4. Any participant with dose reduction or temporary discontinuation will need to be rechallenged before transferring.
•5. Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they:
•a. Have been on a stable dose during participation in the parent study (i.e., no changes to the dose except for changes to weight or age reasons).
•b. Have been compliant with the treatment regimen at the discretion of the investigator
•during participation of the parent study.

排除标准

•1. Previous participation in this study. Participation is defined as signed informed consent.
•2. Female who is pregnant or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method, as defined in Appendix 4 (Section 10.4).
•3. Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
•4. Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.
•5. Participants on permanent treatment dose reduction or temporary treatment discontinuation.
•6. Use of any of the following within the timeframes prior to the transfer visit as stated:
•a. Use of voxelotor within participation of the parent study or anticipated need for this agent during this study.
•b. Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.
•c. Use of erythropoietin or other haematopoietic growth factor treatment within the parent study or anticipated need for such agents during this study.
•d. Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.
•7. Current participation in a study that is not a designated parent study, or planned participation in
•any other clinical trial, for the duration of FLORAL.

研究者

发起方

ovo Nordisk

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