A study to find out how nintedanib is taken up in the body and how well it is tolerated in children and adolescents with Interstitial Lung Disease (ILD).

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

-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:
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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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