At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 39 enrolled
Drug / intervention
Nintedanib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Nintedanib and Placebo for Lung Diseases, Interstitial. Completed, enrolled 39 participants across 43 sites in 21 countries.
Detailed Summary
The main objective of the study is to evaluate dose-exposure and safety of nintedanib in children and adolescents with fibrosing Interstitial Lung Disease (ILD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Interstitial
CountriesArgentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Greece, Hungary, Italy, Mexico, Norway, Poland, Portugal, Russia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartDec 2019
Primary CompletionMay 2022
TodayJul 2026
First PostedSep 17, 2019
Enrollment StartDec 3, 2019
Primary CompletionMay 24, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.8 years ago
Interventions
Nintedanibdrug
Capsule
Placebodrug
Capsule