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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)
NCT04093024 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04093024
The ClinicalTrials.gov registry entry for NCT04093024 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04093024 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04093024?
The interventions under investigation include: Placebo (DRUG), Nintedanib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04093024?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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