NCT03208933已完成3 期
Local Open-label Multicenter Study to Assess the Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis in Russian Clinical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC)
研究概览
简要总结
This study is a national, multicenter, interventional, non-randomized, non-controlled, open-label study to assess the effectiveness of pirfenidone in participants with IPF in Russian clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms consistent with IPF of ≥ 6months duration
- •Participants could have both "confident" or "consistent" with UIP diagnosis of IPF based on clinical, radiologic and pathologic data according to 2011 American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines at the Screening. HRCT scan performed within 24 months before the start of the Screening may be used, if it meets all image acquisition guideline
- •No features supporting an alternative diagnosis on transbronchial biopsy, bronchoalveolar lavage (BAL), or surgical lung biopsy, if performed. Results of the surgical lung biopsy performed within the last 4 years must be confirmed by central review
- •Participants with %FVC ≥ 40 % at the Screening
- •Participants with %Carbon monoxide diffusing capacity (DLCO) ≥ 30 % at the Screening
- •Ability to walk ≥ 100 m during the 6-minute walk test at the Screening
- •Eligible participants must discontinue all prohibited medications at least 28 days before the Screening
- •Female participants of childbearing potential must have negative urine pregnancy test at the Screening and before first dosing on Day 1
排除标准
- •Significant clinical worsening of IPF between Screening and Day 1, in the opinion of the investigator
- •Relevant airways obstruction (i.e. pre-bronchodilator forced expiratory volume (FEV)1/FVC < 0.7)
- •Cigarette smoking within 28 days before the start of treatment or unwilling to avoid tobacco products throughout the study
- •History of clinically significant environmental exposure known to cause pulmonary fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds
- •Known explanation for interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
- •Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/ dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- •During baseline analysis of HRCT, significant coexistent emphysema (emphysema extent greater than extent of fibrosis) confirmed by central review
- •Planned lung transplantation during the study
- •Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
- •Unable to perform 6MWT or to undergo pulmonary function test
- •Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 1 years. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma)
- •History of severe hepatic impairment or end-stage liver disease
- •History of end-stage renal disease requiring dialysis
- •History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
- •Pregnancy or lactation, or intention to become pregnant during the study. Women of childbearing capacity are required to have a negative urine pregnancy test before treatment and must agree to maintain highly effective contraception
- •Liver function test outside specified limits at the Screening: total bilirubin above the upper limit of normal (ULN); aspartate or alanine aminotransferase (AST or ALT) > 3 × ULN; alkaline phosphatase > 2.5 × ULN
- •Creatinine clearance < 30 mL/min, calculated using the Cockcroft-Gault formula
- •Electrocardiogram (ECG) with a QT interval corrected according to Fridericia's formula (QTcF) > 500 msec at the Screening
研究组 & 干预措施
Pirfenidone
Experimental
Participants will be administered pirfenidone 2403 milligram per day (mg/d) orally for 26 weeks in participants with IPF.
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Change From Baseline to Week 26 in Absolute Millilitre (mL) Forced Vital Capacity (FVC)
时间窗: Baseline, Week 26
FVC is a standard pulmonary function test. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Baseline FVC will be the average of the highest FVC measurement recorded at the Screening and Day 1. The FVC at Week 26 will be the average of the highest FVC measurement recorded on two separate days at Week 26.
Change From Baseline to Week 26 in Percent (%) Predicted FVC
时间窗: Baseline, Week 26
Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = \[(observed FVC)/(predicted FVC)\]\*100.
次要结局
- Change From Baseline to Week 26 in 6-Minute Walk Test (6MWT) Distance(Baseline, Week 26)
- Change From Baseline to Week 26 in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score(Baseline, Week 26)
- Change From Baseline to Week 26 in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score(Baseline, Week 26)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(Up to Week 52)
研究者
研究点 (11)
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