NCT01639261Unknown2 期
Eine Phase II Studie über Interferon Gamma 1b Zur Behandlung Der steroidrefraktären Bronchiolitis Obliterans Nach Allogener SZT
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- therapy response
研究概览
简要总结
Improvement of quality of life in patients with BO and establishment of a new third line therapy
详细描述
Primary Objectives:
Objective improvement of lung function, i.e.:
- Improvement of SO2, pO2 or pCO2 in oxygen dependent or improvement of FiO2 in respiration dependent patients ≥ 20 % or
- Reduction of oxygen need in oxygen dependent patients ≥ 1L O2/min with constant parameters at blood gas analysis (BGA) or
- Improvement of obstructive parameters ≥ 20 % or
- Improvement of lung function score (LFS) at least about one grade Improvement of lung function should be detectable at least by two consecutive examinations of lung function or BGA within at least four weeks.
Secondary Objectives
- Morphological improvement of BO/BOOP at CT scan
- Reduction of steroids about at least 20 %
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Age < 18 years
- •Pregnant or nursing woman
- •No appropriate contraception
- •Participation in any other study within 4 weeks before or during the study
- •Active acute GvHD of other organs than the lung > grade II or severe active chronic GvHD
- •No appropriate antibiotic/ antimycotic therapy in documented infection
- •Severe bone marrow suppression (ANC < 1000/ml) or graft failure
- •Liver parameters (bilirubin, gammaGT, AP, ASAT and ALAT) higher than 3 x paramount normal range
- •Kreatinin higher than 3 x paramount normal range
- •Participation in another study within 4 weeks before or during the study
结局指标
主要结局
therapy response
时间窗: 24 weeks
Enhancement of therapy response from 15 % to 50 %
次要结局
未报告次要终点
研究者
Professor Ernst Holler MD
Senior physician
University Hospital Regensburg
研究点 (2)
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