NL-OMON34511已完成2 期
A phase II open label, roll over study of the long term tolerability, safety and efficacy of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis - BIBF roll over study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. patients with primary diagnosis of IPF, who are willing to continue trial medication
- •2. written informed consent signed prior to entry into the study, in accordance with ICH-GCP
- •3. completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
排除标准
- •1. any disease that may put the patient at risk when participating in this trial
- •2. participation in another experimental trial in the last 8 weeks
- •3. women of breast feeding or of child bearing potential, not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy.
- •4. sexually active males not comitting to using condoms during the course of the study and at least 10 weeeks after the end of active therapy.
- •5. patients who require full dose anticoagulation or antiplatelets
- •6. known or suspected active alcohol or drug abuse
- •7. patients not compliant in parent trial, with trial medication or visits
研究者
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