DRKS00018093招募中不适用
A non-interventional study to assess CYP3A induction by high-dose systemic glucocorticoids and by mitotane using 4ß-hydroxycholesterol as a biomarker - GLUCIND
Institut I für Pharmakologie,Universitätsklinikum Köln (AöR)0 个研究点目标入组 64 人开始时间: 2021年10月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •IN CASE OF administration of glucocorticoids/biologicals, one of the following three criteria must apply:
- •- Patients starting a high-dose systemic glucocorticoid therapy ( = 0.5 mg/kg/d prednisolone/ prednisone, = 4 mg/d dexamethasone) for a duration of = 1 week
- •- Patients starting a high-dose systemic glucocorticoid therapy ( = 2 mg/kg/d prednisolone/ prednisone, = 16 mg/d dexamethasone) for a duration of = 4 days
- •- Patients starting a systemic immunosuppressive therapy with the following biologicals:
- •including infliximab, adalimumab, vedolizumab, golimumab, ustekinumab and tofacitinib
- •IN CASE OF administration of mitotane, the following criterion must apply:
- •- Patients with ACC starting an oral mitotane therapy
- •In addition, all of the following three criteria must apply:
- •- Willing and capable to provide written consent prior to enrolment after ample information has been provided
- •- Patients of any sex
- •- Age of at least 18 years
- •- Any drugs mentioned above must be administered only for the approved indication as
- •mentioned in the respective summary of product characteristics (German
- •Fachinformation)
排除标准
- •- Inability to swallow a tablet
- •- Concomitant severe diseases (e.g. cardiovascular, respiratory, liver, renal, or hematologic) of a degree that would limit participation in the study (based on assessment of treating physician); this applies also to the diseases which are treated by the glucocorticoids, immunosuppressants, or mitotane
- •- Any additional medical, psychological, social disorder(s), or other conditions - including seizure disorder that would limit participation in the study
- •- Subjects who are known or suspected to be drug dependent
- •- Subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the foreseeable risks and discomfort to which they will be exposed
- •- Subjects with chronic administration of drugs known to considerably modify CYP3A activity, i.e. moderate or strong inhibitors or inducers (for patients starting to be treated by high-dose or very high-dose glucocorticoids: chronic administration of biologicals or of glucocorticoids below 7.5 mg prednisone/prednisolone or 1 mg dexamethasone without dose changes within two weeks prior and until the end of participation in the study are allowed; for patients starting to be treated by anti-inflammatory biologics: chronic administration of glucocorticoids below 7.5 mg prednisone/prednisolone or 1 mg dexamethasone without dose changes within two weeks prior and until the end of participation in the study are allowed)
- •- Subjects with new administration or which changed doses of drugs known to modify CYP3A activity
研究者
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