跳至主要内容
临床试验/NCT01320865
NCT01320865撤回不适用

Biomarkers in Pulmonary Arterial Hypertension Treated With Nilotinib

The Cleveland Clinic1 个研究点 分布在 1 个国家开始时间: 2010年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kewal Asosingh, Ph.D

Associate Staff

The Cleveland Clinic

研究点 (1)

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