Validation of Different Methods for HepQuant DuO® Blood Sample Collection

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.

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Key information

Conditions

Healthy Adult Participants Liver Disease Chronic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HepQuant DuO Test

Device

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.

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).

Sponsors and collaborators

Lead sponsor

HepQuant, LLC

Industry

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Mar 16, 2026
Registry last updated: Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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