JPRN-jRCT1091220013已完成2 期
A Phase II Study of Inhaled GM-CSF in Patients With Idiopathic Pulmonary Alveolar Proteinosis (iPAP)
Koh Nakata, M.D., Ph.D.Bioscience Medical Research Center (BMRC), Niigata University Medical & Dental Hospital0 个研究点目标入组 40 人开始时间: 2007年8月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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
- >= 16age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. Male or female patients aged 16 - 80 (on the day of enrollment). Patients aged 16 - 19 must provide a signed consent from parents/guardians.
- •2. A written consent from the patient or his/her parents/guardians.
- •3. Able to be hospitalized for a short time.
- •4. Idiopathic pulmonary alveolar proteinosis with serum anti-GM-CSF autoantibody titer grater than 3 mcg/ml and meets A or B below:
- •A. typical pathological findings (accumulation of PAS-positive proteinaceous materials within the alveoli) on transbronchial lung biopsy or surgical lung biopsy (incl. thoracoscopy lung biopsy)
- •B. bronchoalveolar lavage (BAL) fluid showing features characteristic of iPAP (i.e., opaque appearance, proteinaceous materials, low alveolar macrophage count).
- •5. Resting Pao2 < 75 mmHg on room air.
- •6. Diagnosis of PAP
- •7. Life expectancy longer than 3 months.
- •8. Confirmed presence of anti-GM-CSF autoantibodies.
排除标准
- •1. WBC count >/= 12000/mm3
- •2. Concomitant bronchial asthma.
- •3. Fever of >/= 38 degrees Celsius.
- •4. Edema of Grade 2 or more (CTCAE)
- •5. Myeloid malignancy.
- •6. Concomitant congestive heart failure (NYHA III - IV), angina, bleeding tendency, primary lung cancer, or metastatic lung cancer that will make assessment of treatment difficult.
- •7. Concurrent treatment with other cytokines.
- •8. Pregnant or possibly pregnant women or nursing mothers, and women planning to become pregnant during the study.
- •9. Whole lung lavage or sequential segmental lung lavage within 6 months prior to the start of treatment.
- •10. Upper lung lobe fibrosis with a honeycomb pattern or emphysema on x-ray or high-resolution computed tomography (HRCT) scan of the chest performed within 6 months prior to study enrollment.
- •11. For any reason, is judged by the investigator/co-investigators to be inappropriate for study, including inability to complete the protocol or cooperate with the investigator/co-investigators.
- •12. History of serious drug allergy.
研究者
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