Validation of Different Methods for HepQuant DuO® Blood Sample Collection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Difference in d4-cholate concentrations between RTs by VP (reference method) and the SSTs by VP (primary index method).
研究概览
简要总结
This is a study to see the agreement of blood samples collected through different means and tube types for the HepQuant DuO Test. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data from patients living with chronic liver disease and healthy adult volunteers. The study has up to 2 study visits at an outpatient clinic and can take up to 4 weeks for a participant to complete study. At these visits, participants will undergo a HepQuant DuO test and other standard lab tests. In addition, the study team will ask about a participant's experience with different blood sampling methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •adult healthy participant with no major comorbidities and lean body mass (BMI 18-25.5)
- •adult participant with all etiologies of parenchymal chronic liver disease or PBC or PSC with F2-F3 fibrosis or cirrhosis.
排除标准
- •under the age of 18
- •pregnancy
- •Unable to absorb orally administered cholate (examples could include underlying severe gastroparesis or having undergone extensive small bowel resection, conditions or post-operative state that could impair the absorption of the orally administered d4-cholate)
- •NPO (nothing through the mouth) status or those who are unable to ingest a thin liquid by mouth
- •for patients with cirrhosis, any hospital admission within 3 months of enrollment in the study.
研究组 & 干预措施
Blood Sampling
Participant completes a HepQUant DuO test during which the participant ingests a d4-tagged cholate solution and has blood samples drawn 20 and 60 minutes after ingesting oral solution. Blood samples are obtained through direct venipuncture of a peripheral vein, one is collected into a red-top tube and one is collected into a serum separator tube (SST), and simultaneously, a third blood sample is collected into Microtainer SST using a transcutaneous capillary blood collection device.
干预措施: HepQuant DuO Test (Device)
结局指标
主要结局
Difference in d4-cholate concentrations between RTs by VP (reference method) and the SSTs by VP (primary index method).
时间窗: From screening to completion of blood collection at Visit 1 is 2 weeks.
To evaluate the agreement of the HepQuant DuO 20- and 60-minute d4-cholate concentrations between samples collected using Serum Separator Tubes (SST) by venipuncture (VP) (the primary index method) and blood collection in Red-top Tubes (RTs) by VP (the reference method).
次要结局
未报告次要终点