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

Phase 1

• Conditions: Fibrosing interstitial lung disease (ILD) of unknown origin; MedDRA version: 20.0 Level: PT Classification code 10022611 Term: Interstitial lung disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-002744-17-DK
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-30
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 253

Inclusion Criteria

- Age >= 18-85 years
- Confirmed fibrosing ILD which, following multidisciplinary team review, cannot be classified with either high or moderate confidence as a specific idiopathic interstitial pneumonia or other defined ILD
- Progressive disease as considered by the investigator as patient deterioration within the last 6 months, which is defined as a rate of decline in forced vital capacity (FVC) >5% or a significant symptomatic worsening not due to cardiac, pulmonary vascular or other causes
- Extent of fibrosis >10% on high-resolution computed tomography within the last 12 months
-Forced vital capacity >= 45% of predicted value
-Diffusing capacity of the lung for carbon monoxide (DLco) >= 30% of predicted value
-Forced expiratory volume in 1 second/FVC ratio >= 0.7
-Able to do 6-minute walk distance (6MWD) >= 150 meters
-For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 58 days after the last dose of trial treatment
-For men, agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

-Diagnosis with moderate or high confidence of nonspecific interstitial pneumonia and any ILD with an identifiable cause such as connective tissue disease-ILD, chronic hypersensitivity pneumonitis, or others
-Diagnosis of idiopathic pulmonary fibrosis independent of the confidence level
-History of unstable angina or myocardial infarction during the previous 6 months
-Treatment with high dose systemic corticosteroids, or any immunosuppressant other than mycophenolate mofetil/acid (MMF), at any time at least 4 weeks prior to the screening period. Patients being treated with MMF should be on a stable dose that is expected to remain stable throughout the trial and was started at least 3 months prior to screening
-Patients previously treated with pirfenidone or nintedanib
-Patients treated with N-acetyl-cysteine for fibrotic lung disease, at any time within the 4 weeks of the screening period
-Drug treatment for any type of pulmonary hypertension
-Participation in a trial of an investigational medicinal product within the last 4 weeks
-Significant co-existent emphysema (extent greater than extent of fibrosis on high-resolution computed tomography within the last 12 months)
-Significant other organ co-morbidity including hepatic or renal impairment
-Predicted life expectancy < 12 months or on an active transplant waiting list
-Use of any tobacco product in the 12 weeks prior to the start of screening, or any unwillingness to abstain from their use through to the Follow-up Visit
-Illicit drug or alcohol abuse within 12 months prior to screening
-Planned major surgery during the trial
-Hypersensitivity to the active substance or to any of the excipients of pirfenidone
-History of angioedema
-Concomitant use of fluvoxamine
-Clinical evidence of any active infection
-Any history of hepatic impairment, elevation of transaminase enzymes, or liver function test results as: Total bilirubin above the upper limit of normal (ULN), Aspartate aminotransferase or alanine aminotransferase >1.5 × ULN, and Alkaline phosphatase >2.0 × ULN
-Creatinine clearance < 30 millilitre (mL) per minute, calculated using the Cockcroft-Gault formula
-Any serious medical condition, clinically significant abnormality on an Electrocardiogram (ECG) at screening, or laboratory test results
-An ECG with a heart rate corrected QT interval using Fridericia’s formula as >= 500 milliseconds at screening, or a family or personal history of long QT syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified