EUCTR2018-004530-14-PL进行中（未招募）1 期
A double blind, randomised, placebo-controlled trial to evaluate the dose-exposure and safety of nintedanib per os on top of standard of care for 24 weeks, followed by open label treatment with nintedanib of variable duration, in children and adolescents (6 to 17 year-old) with clinically significant fibrosing Interstitial Lung Disease.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •-Children and adolescents 6 to 17 years old at Visit 2.
- •-Signed and dated written informed consent and assent, where applicable, in accordance with ICH-GCP and local legislation prior to admission to the trial.
- •-Male or female patients. Female of childbearing potential (WOCBP) must confirm that sexual abstinence is standard practice and will be continued until 3 months after last drug intake, or be ready and able to use a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly, in combination with one barrier method, from 28 days prior to initiation of study treatment, during treatment and until 3 months after last drug intake. Sexual abstinence is defined as abstinence from any sexual act that may result in pregnancy.
- •-Patients with evidence of fibrosing ILD on HRCT within 12 months of Visit 1 as assessed by the investigator and confirmed by central review.
- •-Patients with FVC % predicted =25% at Visit 2.
- •-Patients with clinically significant disease at Visit 2, as assessed by the investigator based on any of the following: Fan score =3, or documented evidence of clinical progression over time based on either
- •a 5-10% relative decline in FVC% predicted accompanied by worsening symptoms, or
- •a =10% relative decline in FVC % predicted, or
- •increased fibrosis on HRCT, or
- •other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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
- •AST and/or ALT and/or bilirubin >1.5 x ULN, and/or creatinine clearance <30 mL/min (Schwartz formula), and/or underlying chronic liver disease (Child Pugh A, B or C hepatic impairment) at Visit 1; previous treatment with nintedanib, other investigational therapy received within 1 month or 5 half-lives (whichever is shorter but =1 week) prior to Visit 2; significant pulmonary arterial hypertension, any cardiovascular disease excluded by protocol, history of thrombotic event within 12 months of Visit 1, other disease that may interfere with testing procedures or trial participation, or may put the patient at risk; bleeding risk; life expectancy for any concomitant disease other than ILD <2.5 years (investigator assessment); any diagnosed growth disorder or any genetic disorder associated with short stature and/or treatment with growth hormone therapy within 6 months before Visit 2; <13.5 kg of weight at Visit 1.
研究者
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