EUCTR2020-004885-21-BE进行中（未招募）1 期
A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 143
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
- All
入选标准
- •1. Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF) and, when appropriate, an assent form.
- •2. Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
- •3. Did not withdraw consent from a parent study.
- •4. Meets at least 1 of the following criteria:
- •Completed study drug treatment in a parent study.
- •Had study drug interruption(s) in a parent study, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of a parent study.
- •5. For subjects being considered for resumption of participation in this study after enrolling in another Vertex study of investigational CFTR modulators (referred to as another qualified Vertex study”): Completed the ETT visit in another qualified Vertex study before or on the same day as the Returning Visit in this study. If more than 30 days have elapsed since the ETT visit in the other qualified Vertex study, approval of the medical monitor is required.
- •6. Willing to remain on a stable CF treatment regimen (as defined in Section 9.5 of the protocol) through completion of study participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 33
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 107
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
- •2. History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator (e.g., subjects with a history of allergy or hypersensitivity to the study drug).
- •3. Pregnant and breast-feeding females. Female subjects must have a negative pregnancy test at the Day 1 Visit before receiving the first dose of study drug.
- •4. Current participation in an investigational drug trial other than a parent study. Participation in a noninterventional study (including observational studies, registry studies, and studies requiring blood collections without administration of study drug) and screening for another Vertex study is permitted.
- •5. For subjects being considered for resumption of participation in this study after enrolling in another qualified Vertex study, the following exclusion criteria also apply:
- •Subject received the first dose of study drug in the Treatment Period of another qualified Vertex study,
- •Subject has access to commercially available ELX/TEZ/IVA or is receiving managed access program supplied ELX/TEZ/IVA, or
- •Subject departed this study more than once to participate in another qualified Vertex study.
研究者
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