Validation of Different Methods for HepQuant DuO® Blood Sample Collection

N/ANot Yet RecruitingNCT07473817

HepQuant, LLC200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Healthy Adult Participants Liver Disease Chronic

Interventions

HepQuant DuO TestDEVICE

HepQuant DuO is commercially available in the U.S. as a Laboratory Developed Test (LDT), but it will be used in this study as a nonsignificant risk investigational device to measure change in liver function over time.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Difference in d4-cholate concentrations between RTs by VP (reference method) and the SSTs by VP (primary index method).

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).

Time frame: From screening to completion of blood collection at Visit 1 is 2 weeks.