EUCTR2020-005103-39-PL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
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
- •A patient must meet the following inclusion criteria to be eligible for enrollment in the clinical study:
- •1. Prior participant in an Avalyn AP01 study, excluding normal healthy 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 applicable 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 at Screening
- •5. Able to understand and sign, prior to study entry, a written informed consent form (ICF) consistent with International Council on Harmonisation Guideline for Good Clinical Practice (ICH-GCP) and local
- •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 an effective 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
- •The presence of any of the following exclusion criteria excludes a patient from study enrollment:
- •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, 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)
- •11. Hypersensitivity to the active substance or to any of the excipients of pirfenidone
研究者
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