EUCTR2015-000458-40-DE进行中（未招募）1 期
Open-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 study - Infacort004
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
入选标准
- •Subjects successfully completing study Infacort 003, whose inclusion criteria were:
- •1. Male and female children less than 6 years of age.
- •2. A diagnosis of AI as confirmed by an inappropriately low cortisol usually with other supporting tests.
- •3.Receiving appropriate adrenocortical replacement therapy (hydrocortisone with/without fludrocortisone).
- •4.Adequately hydrated and nourished.
- •In addition, the parents/carers must be able to understand and give written Informed Consent (according to AMG §40 (1) 3b) for this extension study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Clinically evident acute AI (adrenal crisis) (Note: the subject can be re-evaluated for eligibility once the episode is over)
- •2.Inability of the child to take oral therapy
- •3.Subjects with clinical signs of acute infection or fever on inclusion (Note: the subject can be re-evaluated for eligibility once the episode is over)
- •4.Any surgical or medical condition that in the opinion of the Investigator may place the subject at higher risk from his/her participation in the study
- •5.Parents/carers of subjects unwilling to consent to saving and propagation of pseudonymised medical data for study reasons
- •6.Subjects who are in a dependent relationship with the Investigator or the Sponsor
研究者
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