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Eine Studie zu Pirfenidon bei Patient*innen mit nicht klassifizierbarer progredienter fibrosierender interstitieller Lungenerkrankung
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
- Atemwegserkrankungen
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Bad Berka
- Berlin
- Gießen
- Heidelberg
- München
Studien-ID:
NCT03099187 2016-002744-17 MA39189
Studienzusammenfassung
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).
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT03099187,MA39189,2016-002744-17
Studien-ID
Pirfenidone, Placebo
Treatments
Lung Diseases, Interstitial
Condition
Official Title
Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD
Einschlusskriterien
All
Gender
≥18 Years & ≤ 85 Years
Age
No
Healthy Volunteers
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
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