At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,058 enrolled
Drug / intervention
pirfenidonedrug
Likely dose
pirfenidone 2403 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.
An Open-Label Extension Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
In Brief
A Phase 3 clinical trial evaluating pirfenidone for Idiopathic Pulmonary Fibrosis. Completed, enrolled 1,058 participants across 1 site.
Detailed Summary
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesUnited States
CollaboratorsHoffmann-La Roche
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartAug 2008
Primary CompletionFeb 2016
TodayJul 2026
First PostedApr 21, 2008
Enrollment StartAug 1, 2008
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 18.2 years ago
Interventions
pirfenidonedrug
Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.