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A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)

Lung Diseases, Interstitial Clinical Trial

Official title:
An Open-label Trial of the Long-term Safety and Tolerability of Nintedanib Per os, on Top of Standard of Care, Over at Least 3 Years, in Children and Adolescents With Clinically Significant Fibrosing Interstitial Lung Disease (InPedILD®-ON)

Clinical Trial Summary

This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study (study 1199-0337, InPedILD™) and for people who are between 6 and 17 years old and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants are in the study for at least 1 year and 5 months or until nintedanib or other treatment options become available outside of this study. During the first 3 years, they visit the study site about 15 times. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05285982
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Active, not recruiting
Phase Phase 3
Start date April 4, 2022
Completion date August 11, 2025
View Details
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