JPRN-jRCTs071230004进行中（未招募）2 期
Phase II study of concurrent induction therapy with nintedanib and anti-inflammatory therapy in untreated progressive pulmonary fibrosis patients - TOP-ILD study
Okamoto Isamu0 个研究点目标入组 32 人开始时间: 2023年4月10日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who are 20 years of age or older at the time of obtaining consent.
- •2) Patients who are not receiving any treatment for interstitial lung disease, such as antifibrotic agents, immunosuppressive agents, or steroids..
- •3) Patients diagnosed with idiopathic non-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia, fibrotic hypersensitivity pneumonitis, or rheumatoid arthritis-associated interstitial lung disease (RA-ILD) and meeting the following progressive criteria within 12 months of observation period (since the test that was the starting point for the diagnosis of PPF) prior to enrollment.
- •Progressive pulmonary fibrosis (PPF) in this study must meet at least 2 of the following 3 criteria, including ii)
- •i) Worsening of respiratory symptoms
- •ii) A decline in lung function as measured by at least 5% (relative change) of %FVC or 15% (relative change) of %DLco corrected for Hb concentration.
- •iii) An increase in fibrotic changes on chest imaging
- •4) Patients with pulmonary fibrosis exceeding at least 10% of the total lung field on HRCT as assessed by the physician in charge on HRCT images (since the test that was the starting point for the diagnosis of PPF). Fibrosis of the lungs is defined as including reticular shadows or traction bronchiectasis, with or without honeycomb lung findings.
- •5) Patients with %FVC greater than 50%.
- •6) Patients with a %DLco greater than 30% and less than 80% corrected for hemoglobin (Hb) concentration
- •7) Patients with rheumatoid arthritis who have stable symptoms (no new treatment for rheumatoid arthritis must have been started or stopped within 6 weeks prior to enrollment)
- •8) Patients with rheumatoid arthritis who have not used steroids or immunosuppressive drugs (tacrolimus, mizoribine, methotrexate, leflunomide, etc.), biologics (infliximab, etanercept, adalimumab, golimumab, tocilizumab, abatacept, etc.) or JAK inhibitors (tofacitinib, baricitinib, etc.) for articular manifestations.
- •However, patients who have used them in the past but not within 12 weeks prior to enrollment may be enrolled.
- •Immunomodulators (e.g., salazosulfapyridine, busiramine, iguratimod) are allowed.
- •9) Patients with AST and ALT levels below 100 IU/L and not Child Pugh B,C (the most recent data within 14 days from the date of registration will be used for registration. (The same day of the week 14 days prior is acceptable, based on the date of registration).
- •10) Creatinine clearance (measured or estimated by Cockcroft-Gault formula):>=30 ml/min (data within 14 days from the date of registration, the most recent data will be used for registration. The same day of the week 14 days prior is acceptable) based on the date of registration.
- •11) Written consent has been obtained from the patient himself/herself after a thorough explanation of the study content has been given prior to enrollment in the study.
排除标准
- •1) Patients diagnosed with IPF, COP, AIP, DIP, RB-ILD, LIP and PPFE
- •2) Patients with interstitial lung disease associated with collagen diseases except rheumatoid arthritis (including cases of overlap syndrome (e.g., Sjogren's syndrome in rheumatoid arthritis patients)) and interstitial lung disease with causes other than fibrotic hypersensitivity pneumonitis
- •3) Patients already receiving steroids, immunosuppressants (tacrolimus, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil,etc.), or antifibrotic agents at the time of enrollment
- •4) Patients with a history of acute exacerbation of interstitial lung disease
- •5) Patients with poorly controlled diabetes mellitus
- •(>=HbA1c 8.0%)
- •6) Patients with predominant airflow obstruction (FEV1/FVC less than 0.7 within 30 days prior to enrollment)
- •7) Patients with complications of acute and chronic systemic infections (e.g., non-tuberculous mycobacterial infections)
- •8) Patients with acute and chronic pancreatitis
- •9) Patients with a history of or complications of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure (New York Heart Association (NYHA) Class III or IV) within 180 days prior to enrollment.
- •(Patients with a history of these diseases more than 180 days ago may be enrolled if they currently have cardiac function within normal limits and are free of cardiac disease-related symptoms.)
- •10)Patients with a history of severe pulmonary hypertension (WHO pulmonary hypertension functional classification (WHO-PH) class III or IV)
- •11) Patients at risk of bleeding
- •(e.g., genetic predisposition to bleeding, a need for fibrinolytic drugs, therapeutic doses of anticoagulants, or a need for high-dose antiplatelet therapy)
- •12) Patients with a history of venous thromboembolism (deep vein thrombosis, pulmonary thromboembolism, etc.) or complications.
- •13) Patients with active malignancy requiring chemotherapy
- •(Patients who have undergone surgical treatment may be enrolled if there has been no recurrence for at least 1 year)
- •14) Patients with clinically problematic psychiatric disorders that would preclude enrollment in the study.
- •15) Pregnant women, lactating women, women who may be currently pregnant, and men and women who are not willing to use contraception during the treatment period.
- •16) Other patients deemed inappropriate by the physician in charge.
研究者
相似试验
已完成
2 期
Phase II study of remission induction therapy with bendamustine and rituximab combination (BR) therapy followed by consolidation therapy with 90Y-labeled iburitumomab tiuxetan for relapsed follicular lymphoma.(BRiZ2012 protocol)follicular lymphomaJPRN-UMIN000008793Society of Lymphoma Treatment in Japan (SoLTJ)28
招募中
不适用
A phase I study of conbination therapy with intratumorak administration of dendritic cells and radiation for far advanced esophageal cancerEsophageal cancerJPRN-UMIN000012218Chiba University6
进行中（未招募）
1 期
Phase II clinical trial of palliativ treatment of patients with advanced non-operable gastric carcinoma: FLOT regimen followed by AIO regimen and irinotecan combined with artificial nutrition and physical activity - impact on quality of life and fatigue: FLOTIRI gastric cancer trialAdvanced non-resectable adenocarcinoma of the stomach and the gastro-oesophageal junctionMedDRA version: 15.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-014895-23-DEniversitätsklinikum Erlangen50
已完成
2 期
The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patientsoral squamous cell carcinomaJPRN-UMIN000014632The workshop of chemotherapy for oral cancer55
尚未招募
不适用
Phase I and II trial of combination therapy using nab-Paclitaxel+Pertuzumab+Trastuzumab for HER2 positive metastatic breast cancermetastatic breast cancerJPRN-UMIN000035869The University of Tokushima Graduate School, Depertment of Thoracic, Endocrine surgery and Oncology, Institute of Health Bioscience30