At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
Nintedanib +1 moredrug
Likely dose
Nintedanib 150 mgfrom 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.
A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary Fibrosis
In Brief
A Phase 2 clinical trial evaluating Nintedanib and Pirfenidoneone for Pulmonary Fibrosis. Completed, enrolled 20 participants across 4 sites.
Detailed Summary
Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31). Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Fibrosis
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartSep 2011
Primary CompletionOct 2015
TodayJul 2026
First PostedAug 16, 2011
Enrollment StartSep 1, 2011
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.9 years ago
Interventions
Nintedanibdrug
150 mg bid
Pirfenidoneonedrug
Existing treatment