EUCTR2016-002744-17-BE进行中（未招募）1 期
MULTICENTER, INTERNATIONAL, DOUBLEBLIND, TWO-ARM, RANDOMIZED, PLACEBO CONTROLLED PHASE II TRIAL OF PIRFENIDONE IN PATIENTS WITH UNCLASSIFIABLE PROGRESSIVE FIBROSING ILD
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 253
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- 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
排除标准
- •-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
研究者
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