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A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease

NCT03099187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2021-01-13

Study results available
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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).

Conditions

  • Lung Diseases, Interstitial

Interventions

DRUG

Pirfenidone

Pirfenidone 267 mg capsules three times in a day.

DRUG

Placebo

Matching placebo capsules three times in a day.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2018-11-21
Completion
2020-01-10
FDA Drug
Yes

Countries

  • Australia
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Ireland
  • Israel
  • Italy
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03099187 on ClinicalTrials.gov