NL-OMON53309已完成2 期
A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infection - BMX-04-001
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- BiomX Ltd.
- 入组人数
- 6
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 99（—）
入选标准
- •1. Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary
- •infection receiving standard of care CF medications.
- •2. Age >= 18 years
- •3. FEV1 >= 40% predicted
- •4. Clinically stable lung disease
- •5. Willing and able to provide adequate sputum samples, using any method
- •(spontaneously expectorated, induced, from home or clinic) at designated study
排除标准
- •1. Known hypersensitivity to bacteriophages, simethicone, or excipients in the
- •formulation
- •2. Receipt of prior bacteriophage therapy (BT) within the 6 months prior to
- •3. Recovery of Burkholderia species from respiratory tract within 1 year prior
- •to screening
- •4. Currently receiving treatment for allergic bronchopulmonary aspergillosis
- •5. Currently having treatment for active infection with non-tuberculous
- •mycobacteria
- •6. History of severe neutropenia
- •7. History of lung transplant
- •8. History of solid organ transplant
- •9. Acquired or primary immunodeficiency syndrome
- •10. Initiation or change in type of CF modulator therapy less than 3 months
- •prior to screening
- •11. Pregnant (or planning to become pregnant) or breastfeeding female
研究者
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