At a glance
ClinicalIndex Comparison RecordN/ACompleted· 425 enrolled
Drug / intervention
Nintedanibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-marketing Surveillance of Ofev Capsules in Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype in Japan
In Brief
An observational study evaluating Nintedanib for Lung Diseases, Interstitial. Completed, enrolled 425 participants across 1 site.
Detailed Summary
The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Interstitial
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartOct 2020
Primary CompletionDec 2024
Study CompletionJan 2025
TodayJul 2026
First PostedSep 23, 2020
Enrollment StartOct 2, 2020
Primary CompletionDec 18, 2024
Study CompletionJan 22, 2025
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 5.8 years ago
Interventions
Nintedanibdrug
Ofev Capsules as prescribed by the treating physician