An Open-label Trial of the Long-term Safety and Tolerability of Nintedanib Per os, on Top of Standard of Care, Over at Least 2 Years, in Children and Adolescents With Clinically Significant Fibrosing Interstitial Lung Disease (InPedILD®-ON)
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- STATUS
- Recruiting
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- End date
- Aug 12, 2024
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- participants needed
- 60
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- sponsor
- Boehringer Ingelheim
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 2 years or until nintedanib or other treatment options become available outside of this study.
During the first 2 years, they visit the study site between 9 and 11 times. Afterwards, they visit the study site every 3 months.
The doctors collect information on any health problems of the participants.
Details
| Condition | Lung Diseases, Interstitial |
|---|---|
| Treatment | Nintedanib (Ofev®) |
| Clinical Study Identifier | NCT05285982 |
| Sponsor | Boehringer Ingelheim |
| Last Modified on | 24 October 2022 |
Eligibility
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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