NCT04097704已完成不适用
An Observational Follow-on Study to Describe the Pharmacogenetics of the CC-90007-CP-003 Study Cohort
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria
研究概览
简要总结
This is a multi-center observational follow-up study to collect saliva samples that allow pharmacogenetic analysis of the subjects that participated in the CC-90007-CP-003 study.
Approximately 28 subjects with moderate and severe hepatic impairment and healthy control subjects with normal hepatic function will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each subject must satisfy all of the following criteria to be enrolled in this study:
- •Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- •Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements.
- •Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- •Subject participated in the CC-90007-CP-003 study.
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •Subject has any condition which places the subject at unacceptable risk if he/she were to participate in the study.
- •Subject has any condition that confounds the ability to interpret data from the study.
- •Sponsor's medical monitor should be consulted on suspected conditions under this exclusion criterion, prior to exclusion.
结局指标
主要结局
Percentage of subjects whose primary saliva sample yields DNA that meets modified PharmacoScan® workflow acceptability criteria
时间窗: Day 1
DNA Quality
次要结局
- Adverse Events (AEs)(Time from ICF to Day 1)
研究者
研究点 (3)
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