NL-OMON43663已完成2 期
A B2-agonist as a CFTR activator in CF - Part 2 - ABBA 2
niversitair Medisch Centrum Utrecht0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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)
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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