Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Cholate Shunt Test
研究概览
简要总结
HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive. The primary goal of this study is to define the intra-individual reproducibility of the HepQuant tests, that is, to see if a person is given the tests several times that the test results are essentially the same each time. Subjects for this study will include healthy controls and patients with chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV) infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis (NASH). The HCV and NASH patients will include men and women, and those with early stage and late stage liver disease as defined by the amount of fibrosis observed in their liver biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests on three separate days within the span of one month. The hypothesis of this study is that HepQuant tests will reproducibly report liver function in healthy controls and patients with all stages of chronic HCV and NASH liver disease and that liver function will decrease as the amount of liver fibrosis increases in the chronic liver disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of chronic HCV or NASH
- •Liver biopsy within 2 years of enrollment
- •Compensated liver disease
排除标准
- •Decompensated liver disease
- •Currently being treated with beta blockers, ACE inhibitors, or other agents affecting FMD
- •Malignancy diagnosed within 5 years of study enrollment without demonstrated clearance
- •History of congestive heart failure
- •Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min/1.73m2)
- •Crohn's disease or any active intestinal inflammatory condition
- •Having an ileal resection
- •Diabetic Gastroparesis
- •Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed at each visit.
- •Inability to consent for one's self
结局指标
主要结局
Cholate Shunt Test
时间窗: Average of all three study visits performed within 30 days
The Cholate Shunt Test result is defined as the ratio of the IV Cholate Clearance to the Oral Cholate Clearance and is expressed as a percentage. The higher the SHUNT percentage, the more the blood flow is shunting around the liver, the more severe the liver disease. The average of the SHUNT test results (ratio of IV Cholate Clearance to Oral Cholate Clearance) from all three time points (3 visits within 30 days) for each participant was used in the calculation of the group SHUNT Test results.
次要结局
- Intra-individual Reproducibility of the Cholate SHUNT Test Across All Subjects(All three study visits within 30 days)
- Intra-class Reproducibility of the Disease Severity Index (DSI) by Histological Fibrosis Stage(Average of DSIs obtained from all three study visits within 30 days)