A Treatment Protocol to Support the Care of Children and Adolescents With Fibrosing Interstitial Lung Disease (ILD)
- Conditions
- Lung Diseases, Interstitial (in Pediatric Populations)Childhood Interstitial Lung Disease (chILD)
- Registration Number
- NCT05624281
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This Expanded Access Program (EAP) is intended to facilitate the availability of OFEV® (nintedanib) to children and adolescents with chronic fibrosing interstitial lung disease (ILD) on top of current standard of care treatment and for whom no satisfactory authorized alternative therapy exists and who cannot participate in the ongoing 1199-0378 trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does nintedanib target in fibrosing interstitial lung disease (ILD) in pediatric populations?
How does nintedanib compare to standard-of-care treatments for childhood interstitial lung disease (chILD) in terms of efficacy and safety?
Which biomarkers are associated with response prediction to nintedanib in fibrosing ILD in children and adolescents?
What are the known adverse events of nintedanib in pediatric patients with ILD and how are they managed?
Are there any combination therapies or competitor drugs being explored for fibrosing interstitial lung disease in children alongside Boehringer Ingelheim's expanded access program?