At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 253 enrolled
Drug / intervention
Pirfenidone +1 moredrug
Likely dose
Pirfenidone 267 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.
Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD
In Brief
A Phase 2 clinical trial evaluating Pirfenidone and Placebo for Lung Diseases, Interstitial. Completed, enrolled 253 participants across 66 sites in 14 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of pirfenidone in participants with fibrosing interstitial lung disease (ILD) who cannot be classified with moderate or high confidence into any other category of fibrosing ILD by multidisciplinary team (MDT) review ("unclassifiable" ILD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Interstitial
CountriesAustralia, Belgium, Canada, Czechia, Denmark, Germany, Greece, Ireland, Israel, Italy, Poland, Portugal, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionNov 2018
Study CompletionJan 2020
TodayJul 2026
First PostedApr 4, 2017
Enrollment StartMay 15, 2017
Primary CompletionNov 21, 2018
Study CompletionJan 10, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.2 years ago
Interventions
Pirfenidonedrug
Pirfenidone 267 mg capsules three times in a day.
Placebodrug
Matching placebo capsules three times in a day.