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NCT04093024 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Lung Diseases, Interstitial, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
- 20
- Study locations
NCT04093024: Completed Phase 3 study of Lung Diseases, Interstitial, sponsored by Boehringer Ingelheim.
NCT04093024 is a Phase 3 study of Lung Diseases, Interstitial that has completed, run by Boehringer Ingelheim. The registered enrollment target is 39 participants, below the 12,505-participant average among 10 other Lung Diseases, Interstitial trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04093024, a Phase 3 study of Lung Diseases, Interstitial, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Area under the plasma concentration-time curve at steady state (AUCt,ss) based on sampling at steady state (at Week 2 and Week 26) after multiple oral administration of Nintedanib by age group over all treatments. Values of samples taken at Week 2 (for randomised Nintedanib participants) and at Week 26 (for randomised placebo participants) were used. Missing values at Week 2 of randomised Nintedanib participants were replaced with values taken at Week 26.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nintedanib
Study Locations (20)
Other
- Hospital de Pediatría " Prof. Dr. Juan P. Garrahan" - CABA
- Hospital de Niños Dr. Ricardo Gutierrez - CABA
- INSARES - Mendoza
- Brussels - UNIV HUDERF - Brussels
- Serviços Medicos Respirar Sul Fluminense - Barra Mansa
- Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP - São Paulo
- Teaching Hospital Motol, Oncology Clinic - Prague
- Aarhus University Hospital - Aarhus N
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center - Pittsburgh
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Indiana
- Riley Hospital for Children at Indiana University Health - Indianapolis
Missouri
- Children's Mercy Hospitals and Clinics - Kansas City
New York
- Weill Cornell Medicine - New York
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-12-03 |
| Est. Completion | 2022-05-24 |
| Phase | Phase 3 |
What the finished NCT04093024 record still lists
NCT04093024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 12,505-participant average among 10 other Lung Diseases, Interstitial trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Lung Diseases, Interstitial appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04093024 names 20 study sites across 12 states, led by Other, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT04093024 about?
NCT04093024 is a clinical study titled "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)". 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).
What is the current status of trial NCT04093024?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2019-12-03. Estimated completion is 2022-05-24.
What conditions does trial NCT04093024 study?
This clinical trial studies the following conditions: Lung Diseases, Interstitial.
What interventions are being tested in trial NCT04093024?
The interventions under investigation include: Placebo (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT04093024?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04093024 being conducted?
This trial has 20 study locations across California, Colorado, Indiana, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04093024's enrollment target sits among peer trials
39 8th of 10 higher than 3 of 10 other Lung Diseases, Interstitial trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Diseases, Interstitial trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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