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NCT05285982 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
NCT05285982 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 54 participants.
The verdict
NCT05285982, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
Study 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 called InPedILD (study 1199-0337) and for people who are between 6 and 17 years old (in France, between 12 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 coming from the previous study are in this study for at least 3 years or until nintedanib or other treatment options become available outside of this study. New participants are in the study until the overall end of study meaning for at least 1.5 years. Participants visit the study site about 15 times for a study participation of 3 years. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.
Interventions
- DRUG Nintedanib (Ofev®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2025-08-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05285982
The ClinicalTrials.gov registry entry for NCT05285982 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nintedanib (Ofev®) is the first listed.
NCT05285982 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05285982 about?
NCT05285982 is a clinical study titled "A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)". 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 called InPedILD (study 1199-0337) and for people who are between 6 and 17 years old (in France, between 12 and 17 years old) and...
What is the current status of trial NCT05285982?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2022-04-06. Estimated completion is 2025-08-13.
What interventions are being tested in trial NCT05285982?
The interventions under investigation include: Nintedanib (Ofev®) (DRUG).
Who is sponsoring clinical trial NCT05285982?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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