Validation of Different Methods for HepQuant DuO® Blood Sample Collection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- HepQuant, LLC
- Enrollment
- 200
- Primary Endpoint
- Difference in d4-cholate concentrations between RTs by VP (reference method) and the SSTs by VP (primary index method).
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: HepQuant DuO Test (Device)
Outcomes
Primary Outcomes
Difference in d4-cholate concentrations between RTs by VP (reference method) and the SSTs by VP (primary index method).
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported