CTIS2023-508729-28-00进行中（未招募）1 期
A participant - and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in patients with idiopathic pulmonary fibrosis - CADPT09A12201
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 109
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 65+（—）
- 性别
- All
入选标准
- •Written informed consent must be obtained before any assessment is performed., Male and female participants at least 40 years of age, IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guideline for diagnosis and management, within 5 years of screening (HRCT and surgical lung biopsy or cryobiopsy (if available) will be read by a central reader), FVC =45% predicted at screening with no clinically significant deterioration, as determined by investigator between the screening visit and randomization, as determined by the investigator., DLCO, corrected for hemoglobin, =25% predicted (inclusive) at screening with no clinically significant deterioration, as determined by investigator between the screening visit and randomization, as determined by the investigator., Unlikely to die from cause other than IPF within the next 2 years, in the opinion of the investigator, Unlikely to undergo lung transplantation during this trial in the opinion of the investigator, If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization, Able to communicate well with the investigator, to understand and comply with the requirements of the study
排除标准
- •Unable to perform PFTs, 6MWT or undergo HRCT procedure at time of screening, Pulmonary hypertension requiring pharmacologic treatment, Any surgical, medical (e.g. uncontrolled hypertension, diabetes), psychiatric or additional physical condition that the investigator feels may jeopardize the participant in case of participation in this study. The investigator should make this determination in consideration of the patient’s medical history and/or clinical or laboratory evidence of any of the following: • Moderate or severe hepatic failure (Child-Pugh classification stage B or C) • Significant renal impairment with an estimated glomerular filtration rate (eGFR) < 30 mL/min as calculated by the CKD-EPI formula, Inability to comply with study requirements., Other unspecified reason that in the opinion of the investigator in consultation with the sponsor makes the participant unsuitable for enrollment, Active drug or alcohol abuse (as defined by the investigator) within 3 months prior to screening., Use of any inhaled substance, including but not limited to tobacco or marijuana products and/ or the use of any electronic cigarette or vaping device, within 12 weeks prior to screening (note that respiratory inhalers or nebulizers for delivery of prescribed medication for pulmonary disease are allowed)., Any one of the following screening values of complete blood count laboratory values: • Hemoglobin levels < 10.0 g/dL • Total leukocyte count < 3,000/µL • Neutrophils <1.5 x 103 /µL • Platelets <100.0 x 103 /µL • Total Bilirubin > 1.5 mg/dL (in the absence of known Gilbert's syndrome) • Aspartate transaminase (AST) or alanine transaminase (ALT) > 2X upper limit of normal, Peripheral capillary oxygen saturation (SpO2) <90% at rest (if on supplemental oxygen, must be =2 L/min at rest), Airway obstruction (i.e., prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening as defined by an absolute increase of =12% and an increase of = 200ml in FEV1 or FVC, or both, after bronchodilator use, compared with the values before bronchodilator use at screening., Emphysema >20% on screening HRCT as assessed visually by central reader., History of major organ, hematopoietic stem cell or bone marrow transplant, Fibrosis <10% on screening HRCT as assessed visually by central reader., Clinical diagnosis of any connective tissue disease (including but not limited to scleroderma, polymyositis/ dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the investigator applying the recent ERS/ ATS research statement. Note: serological testing is not needed if not clinically indicated., Other known causes of interstitial lung disease (e.g. domestic or occupational environmental exposures, drug toxicity) or another identifiable interstitial lung disease, Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization, Currently receiving high-dose corticosteroid, cytotoxic therapy (e.g. chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g. bosentan), unapproved (e.g. IFN-?, penicillamine, cyclosporine, mycophenolate, N-acetylcysteine [may vary by country]) and/or investigational therapy or device for IPF or administration of such therapeutics within 5 half-lives of the IP prior to initial screening in this study. A curre
研究者
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