EUCTR2012-000564-14-GB进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N–Acetylcysteine in Patients with Idiopathic Pulmonary Fibrosis with Background Treatment of Pirfenidone - PANORAMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 122
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
- •1. Clinical symptoms consistent with IPF of =3 months duration (relative to Day 1)
- •2. Diagnosis of IPF =3 months before Day 1 (and no more than 4 years ago). Diagnosis date is defined as the first instance in which a patient was informed of having IPF or there is documented evidence of UIP diagnosed by HRCT
- •3. Age =40 and 80 years inclusive, on Day 1
- •4. Diagnosis of UIP or IPF by HRCT and surgical lung biopsy (SLB). Previous HRCT scans, typically and if available, one at the point of time of diagnosis and one more recent, made during the last year before study inclusion) will be used and assessed by a central Reading Committee.
- •5. Extent of fibrotic changes (honeycombing, reticular changes) greater than the extent of emphysema on the HRCT scan
- •6. No features supporting an alternative diagnosis on SLB, transbronchial biopsy (TBB), or bronchoalveolar lavage (BAL), if available. (SLB, TBB and BAL are not required for entry into the study.)
- •7. Percent predicted FVC =50% and =90% at Screening, confirmed by central review
- •8. Percent predicted DLCO =30% and =90% corrected by hemoglobin, at Screening, confirmed by central review.
- •9. Forced expiratory volume in 1 second (FEV1)/FVC ratio =0.75 confirmed by central review
- •Must be on a dose of pirfenidone not less than 1602 mg/day for at least 8 weeks prior to randomization at Day 1.
- •10. Able to understand and sign a written informed consent form
- •11. Able to understand the importance of adherence to study treatment and the study protocol and willing to follow all study requirements, including the concomitant medication restrictions, throughout the study
- •12. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced, one of the two methods of birth control should be an oral contraceptive (e.g., oral contraceptive and a spermicide).
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Significant clinical worsening of IPF between Screen. and Day 1, in the opinion of the Inv.
- •2.Unlikely to comply with the requirements of this study, in the opinion of the Inv.
- •3.Patient-reported cigarette smoking within 3 months of Screen. or unwilling to avoid use of tobacco products throughout the study
- •4.Hist. 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
- •5.Known cause of interstitial lung disease, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, cryptogenic organizing pneumonia
- •6.Human immunodeficiency virus (HIV), viral hepatitis B or C
- •7.Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- •8.Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis (as a diffuse inflammation of connective tissue and or skin)
- •9.In list for lung transplantation: expected to receive a lung transplant within 6 months from Day 1
- •10.Any hist. of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months (relative to Day 1). This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma, squamous skin carcinoma)
- •11.Any condition other than IPF that, in the opinion of the Inv., is likely to result in the death of the patient within the next 12 months
- •12.Hist. of severe hepatic impairment or end-stage liver disease
- •13.Hist. of end-stage renal disease requiring dialysis
- •14.Hist. of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months (relative to Day 1), including but not limited to the following:
- •a.Unstable angina pectoris or myocardial infarction
- •b.Congestive heart failure requiring hospitalization
- •c.Uncontrolled clinically significant arrhythmias
- •15.Any condition that, in the opinion of the Inv., might be significantly exacerbated by the known side effects associated with the administration of NAC taken as a single medication
- •16.Known or suspected presence of a peptic ulcer
- •17.Pregnancy or lactation
- •18.Hist. of alcohol or substance abuse in the past 2 years
- •19.Family or personal hist. of long QT syndrome
- •20.Any contraindications according to the current NAC-product SPC
- •21.Any of the following liver chemistry criteria above specified limits:
- •a.Total bilirubin above the upper limit of normal ULN
- •b.Aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) >2 x ULN
- •c.Alkaline phosphatase >2.5 x ULN
- •22.Creatinine clearance CrCl <30 mL/min, calculated using the Cockcroft-Gault formula
- •23.ECG with a heart-rate–corrected QT interval using Bazett’s formula QTcB >500 ms at Screening
研究者
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