Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measuring circulating markers of Nilotinib affect
研究概览
简要总结
The investigators hypothesize that bone marrow progenitor cells are mobilized into the circulation in PAH, home to the lungs and differentiate into mast cells, which promote vascular remodeling and vasoconstriction through release of renin and chymase. As a corollary to this, the investigators hypothesize that anti cKit tyrosine kinase inhibitor (TKI), nilotinib, provides clinical benefit to patients through inhibition of mast cell progenitor proliferation, mobilization and differentiation. To test this, the investigators will determine if mast cell progenitors and mast cell biomarkers are related to nilotinib clinical response. This will be an ancillary study, part of a placebo-controlled, double-blind multi center clinical trial of nilotinib in pulmonary arterial hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •This study is a substudy and subjects must be enrolled in the main trial:
- •See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737)
- •http://clinicaltrials.gov/ct2/show/NCT01179737?
排除标准
- •Subjects are not enrolled in the main study:
- •See Study Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Nilotinib (AMN107) in Pulmonary Arterial Hypertension (PAH) In clinical trials. (clinical Trial ID NCT01179737)
- •http://clinicaltrials.gov/ct2/show/NCT01179737?term=tasigna+and+pulmonary+hypertension&rank=1
结局指标
主要结局
Measuring circulating markers of Nilotinib affect
时间窗: within one year of the end of the study
We will measure markers of mast cell activation in blood and urine before and during treatment with nilotinib.
次要结局
- Evaluate effect of Nilotinib on the activation of mast cells.(within one year of the end of the study)
研究者
Kewal Asosingh, Ph.D
Associate Staff
The Cleveland Clinic
