A Non-Interventional Pilot Study Assessing Whether Lysyl Oxidase-like 2 (LOXL2) is Present in Subjects With Scleroderma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Summarized the number and percentage of subjects with elevated LOXL2 levels
研究概览
简要总结
To treat patients with scleroderma by blocking the expression of LOXL2. The investigators first need to confirm (through observation) that LOXL2 is overexpressed in disease.
详细描述
Scleroderma is a chronic skin-hardening disease. There are two types of scleroderma. The first type is called limited cutaneous scleroderma, where disrupted blood flow causes skin discoloration and sometimes patients experience high blood pressure in their arteries. The second type is called diffuse cutaneous scleroderma and it is much more aggressive, affecting a larger area of skin causing organ damage. This study will determine if the disease is associated with an elevated expression of LOXL2 levels in tissue samples from patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Over 18 years of age
- •Documented diagnosis of scleroderma
- •Willing and able to provide written informed consent
排除标准
- •Use of experimental therapies within 28 days prior to Screening.
- •Aspirin use > 81 mg daily within 1 week prior to Screening.
- •Any lab abnormality or concurrent medical condition that, in the opinion of the investigator would make the patient ineligible for the study
结局指标
主要结局
Summarized the number and percentage of subjects with elevated LOXL2 levels
时间窗: Baseline
次要结局
未报告次要终点