EUCTR2020-005103-39-CZ进行中（未招募）1 期
Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- 性别
- All
入选标准
- •1. Prior participant in an Avalyn AP01 study, excluding normal volunteers
- •2. Patients with no other treatment options with ILDs, including but not limited to IPF, fibrosing phenotype ILD, pulmonary involvement of scleroderma, rheumatoid lung and silicosis. Prior Sponsor approval of non-Avalyn study rollover patients is required.
- •3. Diagnosed chronic progressive fibrotic ILD, including IPF, without treatment alternatives such as:
- •a. Not eligible for oral pirfenidone and nintedanib due to national formulary restrictions or lack of regulatory approval
- •b. Intolerant to oral pirfenidone and nintedanib, if previously offered
- •c. Not eligible for an ongoing clinical study of AP01 other than this study
- •4. Age greater than 18 years
- •5. Able to understand and sign a written informed consent form (ICF)
- •6. 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
- •7. Females of childbearing potential (FOCBP) must use a contraceptive method during the clinical study and 30 days after the last dose of AP01 as described in Section 7.3.6, Pregnancy Testing.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Disease-Related Exclusions
- •1. Significant clinical worsening of ILD/IPF for AP01 naïve patients between Screening and Day 1, in the opinion of the investigator
- •2. Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study, in the opinion of the investigator
- •3. History of acute IPF exacerbation requiring hospitalization in the last 30 days
- •4. Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis
- •Medical Exclusions
- •5. Females with a positive pregnancy test at Screening (AP01 naïve patients) or Baseline (Rollover patients from previous study) or are currently breastfeeding
- •6. Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for localized cancer (e.g., basal cell carcinoma)
- •7. Any condition other than ILD/IPF that, in the opinion of the investigator, is likely to result in the death of the patient within the next 6 months
- •8. History of severe hepatic impairment or end-stage liver disease or AST or ALT greater than 5 times the upper limit of normal at Screening (AP01 naïve patients)
- •9. History of end-stage renal disease requiring dialysis
- •10. Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives of the previously administered investigational product (IP) (AP01 naïve patients only)
研究者
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