EUCTR2015-001317-28-NL进行中（未招募）1 期
A B2-agonist as a CFTR activator in CF - Part 2 - ABBA 2
MC Utrecht0 个研究点开始时间: 2015年5月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •-CFTR genotype compound/A455E or compound/R117H
- •-Already had a rectal biopsy to produce an organoid
- •-Males and females, aged 18 years or older on the date of informed consent
- •-Signed informed consent form (ICF)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Severe acute exacerbation or pulmonary infection during last four weeks (needing intravenous treatment and/or systemic corticosteroids)
- •-Known cardiovascular medical history like cardiac failure, arrhythmias, ischemic cardiac disease, long QT interval syndrome and hypertension
- •-Known hyperthyroidism, thyrotoxicosis, galactose intolerance, lactase deficiency or glucose-galactose malabsorption
- •-Haemoglobin A1C (HBA1C) > 45 mmol/mol
- •-Use of oral B2-agonist one week prior to the start of the study (V1)
- •-Use of: heart glycoside, high dose sympathomimetics, theophylline, thiazide diuretics or non-selective beta-blockers
- •-Pregnancy or breastfeeding
- •-Participation in another drug-investigating clinical study at the start
- •-Inability to follow instructions of the investigator
研究者
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