KCT0009628尚未招募Unknown
A Multicenter, Double blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Pirfenidone vs Placebo in Patients with Progressive Pulmonary Fibrosis
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 102
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Those aged 19 or older at the time of screening
- •2) At the time of screening, the clinical research director and the person in charge will be in line with the PPF definition*
- •*In the International Society of Respiratory Diseases' Clinical Practice Guidelines (2022 ATS/ERS/JRS/ALAT clinical practice guideline), PPF is defined as a case that satisfies at least two of the following three criteria (deterioration of respiratory symptoms; physiological evidence of disease progression; radiological evidence of disease progression) in the past year among ILD patients with radiological evidence of pulmonary fibrosis.
- •1) aggravation of respiratory symptoms
- •2) Physiological evidence of disease progression: Those with an absolute value of FVC reduction during a 1-year follow-up of = 5% or those with an absolute value of a reduction in hemoglobin value (Dlco) during a 1-year follow-up of = 10% predicted
- •3) Imaging evidence (one or more of the following, blindfolded evaluators):
- •a. Tract bronchial/bronchial dilatation (Trace bronchial/bronchioelectasis) range, deterioration
- •b. New ground glass opacity and traction bronchial dilatation
- •c. New micro-network (Reticulation)
- •d. Degradation of the degree and category of reticular abnormality
- •e. Newly discovered honeycombing or deterioration of existing honeycomb shapes
- •f. Deterioration of Lobar volume loss of lung lobe
- •3) High-resolution computed tomography (HRCT) at screening shows a degree of fibrosis of 10% or more
- •4) FVC 45% predicted or higher at screening time
- •5) Dlco 30% predicated or higher at screening time
- •6) 6 minute walk distance (6MWD) at the time of screening. Those with a distance of 150m or higher
- •7) A person who has voluntarily agreed in writing to participate in this clinical trial
排除标准
- •1) Screening visit criteria, FEV1/FVC <0.7 after administration of bronchodilators
- •2) ILD patients with radiation, sarcoidosis, pneumothoraxic hearing loss pneumonia, HIV, viral hepatitis, and cancer
- •3) Persons with active infections including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection or cellulitis
- •4) Those who need a lung transplant within the clinical trial period after randomization, as judged by the clinical research director and the person in charge
- •5) Those who cannot undergo a pulmonary function test
- •6) Those who are likely to die or cause serious disability or have a history of malignancy within the past 5 years (skin* or cervical cancer within 2 years)
- •*Localized cancer (e.g., basal cell carcinoma)
- •7) Those with a history of advanced cirrhosis or clinically significant liver disease, such as patients with severe liver disorder or end-stage epilepsy
- •8) Those with a history of unstable heart or lung disease (excluding IPF) within the last 6 months, including, but not limited to, myocardial infarction, unstable angina, coronary bypass, coronary angioplasty or uncontrolled arrhythmia requiring hospitalization, as follows
- •A. Myocardial infarction, unstable angina, coronary bypass or coronary angioplasty
- •B. Congestion heart failure requiring hospitalization
- •C. Uncontrolled arrhythmia
- •D. Asthma or chronic bronchitis requiring hospitalization within the last 6 months
- •E. Acute exacerbation
- •9) Those who are contraindicated (who have hypersensitivity to the ingredients of clinical trial drugs) according to Piresco's permission
- •10) Pregnant women or nursing mothers
- •11) A person who has a history of alcohol or substance abuse in the past two years as of screening visits
- •12) A person who has a history of conditions or habits related to consciousness change and aspiration risk over the past two years as of screening visits
- •13) A person who has a family history or personal history of Long QT syndrome
- •14) Those treated with one of the following drugs: Fluvoxamine (any time), all research drugs within the last 6 months, specific interventional drugs that start more than 6 months ago and do not maintain stable pH thereafter and throughout the study period.
- •15) Those with severe pulmonary hypertension (PULMONARY VASCULAR RESISTANCE, PVR > 900 dynes/sec/cm-5)
- •16) Current smokers
- •17) Subjects who meet the criteria above the specified limits in the liver function test* according to the institution-specific criteria during clinical laboratory examination
- •*Total bilirubin > 2.5 Upper Limit of Normal (ULN), AST/SGOT or ALT/SGPT > 2.5 ULN; alkaline phosphatase > 2.5 ULN, eGFR <30 ml/min.
- •18) Those who have previously used Piresco tablets have applied 15 mg or more of prednisolone equivalent per day, or have used conventional steroid or immunosuppressant therapy within the past 3 months if they are less than 15 mg (excluding conventional steroids and immunosuppressant stable dose users)
- •*: Methylprednisolone, Prednisolone , : Azathioprine, cyclophosphamide, cyclosporin, mycophenolate mofetil
- •19) A person who has a history of angioplasmic edema associated with the use of a previous pyresco tablet
- •20) A person who performs combination therapy with a drug that simultaneously inhibits CYP1A2, CYP2C9, CYP2c19, CYP2D6, and CYP2E18
- •21) Those undergoing combination therapy (full list of CYP drug interactions) with potent inhibitors or inducers of CYP1A28
- •22) A person who is not appropriate to part
研究者
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