NL-OMON52355招募中2 期
Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis - AP01-005
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 4
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
- 18 至 64（—）
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
- •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 (Avalyn Pharma, Inc.) approval of
- •non-Avalyn study rollover patients is required.
- •3. Diagnosed chronic progressive fibrotic lung disease, 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 laws
- •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 must use an effective contraceptive method
- •during the clinical study and 30 days after the last dose of AP01
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 IPF/ILD 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
- •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 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 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
- •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
- •11. Hypersensitivity to the active substance or to any of the excipients of
- •pirfenidone
研究者
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