EUCTR2014-002387-32-GB进行中（未招募）1 期
Phase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis - PROteKT
niversity of Liverpool0 个研究点目标入组 50 人开始时间: 2014年6月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •1.Age 10 to 18 years inclusive.
- •2.Diagnosis of cystic fibrosis (established by sweat test or genotype).
- •3.Planned, clinically indicated, course of treatment with IV tobramycin.
- •4.Ability to give informed consent.
- •5.Willingness to comply with all study requirements.
- •6. Able to take tablets.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Existing treatment with a statin.
- •2.Previous adverse reaction to a statin.
- •3.Co-enrolment in other drug trials*, or completion of a previous CTIMP within the last 30 days
- •4.Previous randomisation in the PROteKT trial
- •5.Patients taking any of the following medications: Ciclosporin, Protease Inhibitors, Fibrates, Ezetimibe, Erythromycin (but not other macrolides), Eltrombopag, Dronedarone, Itraconazole, Coumarins, Oral contraceptives, nicotinic acid, fusidic acid and Simepravir.
- •6.Female participants who are pregnant or lactating (female participants of childbearing potential must use a barrier method of contraception if sexually active whilst taking rosuvastatin and for 7 days afterwards).
- •7.Patients of Asian ancestry (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
- •8.Patients with renal disease (eGFR<60ml/min/1.73m², using the Schwartz formula, in the 6 months preceding randomisation).
- •9.Patients with current elevation in transaminases exceeding 3x the upper limit of normal.
- •10.Family history, or personal history, of hereditary muscular disorders.
- •11.Patients with myopathy.
- •12.Patients with a history of, or active alcohol abuse.
- •13.Patients with hypothyroidism.
- •14.Patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
- •15.Patients who are Hepatitis C positive or HIV-positive.
- •*Patients who are currently taking part in TORPEDO-CF are allowed to take part in PROteKT as long as their date of randomisation into TORPEDO-CF is not within the previous six months of the screening date for PROteKT.
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