CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Pirfenidonedrug
Likely dose
Pirfenidone up to 3600 mg/day orally in divided doses three times daily with foodAI-extracted
Key inclusion· 6
  • ✓Clinical symptoms consistent with IPF for ≥3 months
  • ✓Age 40–85 years, inclusive
  • ✓At enrollment (baseline), percent predicted FVC ≥45% and percent predicted DLCO ≥30%
  • ✓High-resolution CT scan showing definite IPF, or surgical lung biopsy showing definite/probable UIP
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00080223
NCT00080223Phase 2Completed
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An Open-Label, Phase 2 Study of the Safety of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis

Genentech, Inc.·interventional·Posted Mar 26, 2004·Updated Apr 17, 2017

In Brief

A Phase 2 clinical trial evaluating Pirfenidone for Idiopathic Pulmonary Fibrosis and Pulmonary Fibrosis. Completed, enrolled 83 participants across 27 sites.

Detailed Summary

To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 26, 2004
Enrollment StartAug 31, 2003
Primary CompletionApr 30, 2015
TodayJul 2, 2026
Enrollment to primary: 11.7 yearsPosted 22.3 years ago

Interventions

Pirfenidonedrug

up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study