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A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
Study Purpose
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).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years - 85 Years
Gender
All
More Inclusion & Exclusion Criteria
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 participants 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
- 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
non-hormonal or hormonal contraceptive method with a failure rate of < 1% per year
during the treatment period and for at least 90 days after the last dose of
pirfenidone
- For men, agreement to remain abstinent or use contraceptive measures, and agreement to
refrain from donating sperm
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 within the 4 weeks of the screening
period.
Participants 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
- Participants previously treated with pirfenidone or nintedanib
- Participants 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 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 milliliter (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
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Hoffmann-La Roche
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Clinical Trials
Principal Investigator Affiliation
Hoffmann-La Roche
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Diseases, Interstitial
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia