At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 752 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.
An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
In Brief
A Phase 3 clinical trial evaluating Nintedanib for Idiopathic Pulmonary Fibrosis. Completed, enrolled 752 participants across 173 sites in 24 countries.
Detailed Summary
The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesAustralia, Belgium, Canada, Chile, China, Czechia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Russia, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJun 2012
Primary CompletionJul 2017
Study CompletionFeb 2021
TodayJul 2026
First PostedJun 14, 2012
Enrollment StartJun 6, 2012
Primary CompletionJul 5, 2017
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 14.0 years ago
Interventions
Nintedanibdrug
Nintedanib twice a day