NL-OMON50041已完成2 期
A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis (ATLAS Study) - ATLAS study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
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 99（—）
入选标准
- •1. Male and female patients, at least 40 years of age at Screening
- •2. Not eligible for oral pirfenidone and nintedanib due to national formulary;
- •restrictions OR intolerant to or unwilling to start oral pirfenidone and
- •nintedanib, if previously offered;
- •3. Clinical symptoms consistent with IPF of * 12 months duration (with or
- •without IPF diagnosis)
- •4. Diagnosis of IPF, defined as the first instance in which a patient was
- •informed of having IPF, no more than 60 months before randomization;
- •Patients that have had an IPF diagnosis * 1 year, the following criteria must
- •- HRCT and/or Surgical Lung Biopsy findings consistent with UIP. If
- •honeycombing is not present on the HRCT, then one or both of the following
- •criteria must be present:
- •* Disease progression since diagnosis by HRCT and/or
- •* An absolute loss of FVC * 5% percent predicted over the past 12 months,
- •Patients that have had IPF diagnosis within the last year, the following
- •criteria must be met:
- •- Diagnosis of Usual Interstitial Pneumonia (UIP) or IPF by HRCT (HRCT must be
- •performed within 12 months prior to Screening) and/or Surgical Lung Biopsy
- •5. Extent of fibrotic changes (honeycombing, reticular changes) greater than
- •the extent of emphysema on HRCT scan, confirmed by central review;
- •6. No features supporting an alternative diagnosis on transbronchial biopsy,
- •BAL, or surgical lung biopsy, if performed;
- •7. 40% * FVC * 90 % predicted at Screening based on Global Lung Initiative12
- •equations. The first 20 patients randomized must have FVC * 50% predicted.
- •After the first 20 patients have randomized, patients with FVC 40% - 50%
- •predicted will be allowed to be randomized in the
- •study but randomization for these patients will be capped at 20;
- •8. Change in FVC (measured in liters) between Screening and Day 1 (pre-dose
- •measurement) must be a < 10% relative difference;
- •9. 30 * % DLCO * 90% at Screening;
- •10. In the investigator's opinion, no evidence of improvement in measure of IPF
- •disease severity over the preceding year;
- •11. FEV1/FVC * 70%;
- •12. Able to understand and sign a written informed consent form;
- •13. 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;
排除标准
- •1. Significant clinical worsening of IPF 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 last3
- •4. History of clinically significant environmental exposure known to cause
- •pulmonary fibrosis, including but not limited to drugs (such as amiodarone),
- •asbestos, beryllium, radiation, and domestic birds;
- •5. Known explanation for interstitial lung disease, including but not limited
- •to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis,
- •bronchiolitis obliterans organizing pneumonia, human
- •immunodeficiency virus, viral hepatitis, and cancer;
- •6. Clinical diagnosis of any connective tissue disease, including but not
- •limited to scleroderma, polymyositis/dermatomyositis, systemic lupus
- •erythematosus, and rheumatoid arthritis;
- •7. Current diagnosis of asthma or chronic obstructive pulmonary disease;
- •8. Clinical evidence of active infection, including but not limited to
- •bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis;
- •9. Females with a positive pregnancy test at Screening or are currently
- •breastfeeding
- •10. 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);
- •11. 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;
- •12. History of severe hepatic impairment or end-stage liver disease or ALT or
- •AST greater than 5 times the upper limit of normal at Screening;
- •13. History of end-stage renal disease requiring dialysis
- •14. 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.
研究者
相似试验
已完成
1 期
A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis (ATLAS Study)Respiratory - Other respiratory disorders / diseasesIdiopathic Pulmonary FibrosisACTRN12618001838202Avalyn Pharma Pty Ltd91
已完成
1 期
A Phase I, Randomised, Open Label Study of the Safety, Tolerability and Pharmacokinetics of Single Sublingual or Oral Dose of GDN-1 in Adult Healthy Volunteers.This trial is to assess the tolerability and pharmacokinetics in healthy adult volunteers and does not focus on any particular health condition or problem.Subsequent studies are planned to evaluate efficacy in promoting improved exercise endurance and recovery, reduced muscle damage and soreness post exercise and for its lipid lowering effects in appropriate populations.This trial is to assess the tolerability and pharmacokinetics in healthy adult volunteers and does not focus on any particular health condition or problem.Subsequent studies are planned to evaluate efficacy in promoting improved exercise endurance and recovery, reduced muscle damage and soreness post exercise and for its lipid lowering effects in appropriate populations.Other - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12615000560594Gordagen Pharmaceuticals Pty Ltd60
进行中（未招募）
1 期
AC220 in adults with refractory/relapsed Acute Myeloid LeukaemiaAcute Myeloid LeukemiaEUCTR2011-005408-13-GBAmbit BioSciences Corporation76
进行中（未招募）
1 期
A Phase 2, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)EUCTR2011-005408-13-ITASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.76
已完成
1 期
A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)Relapsed/Refractory (R/R) Higher Risk Myelodysplastic Syndrome (MDS)JPRN-jRCT1080224851Astellas Pharma Global Development, Inc.43