Validation of Different Methods for HepQuant DuO® Blood Sample Collection

March 11, 2026 updated by: HepQuant, LLC
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants ranging from healthy to living with chronic liver disease will consist of:

50% healthy participants 25% CLD participants with non-cirrhotic fibrosis 25% CLD participants with cirrhosis of which no more than 10% of the total study participants will have Child-Pugh class of B or C.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: HepQuant DuO Test
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From screening to completion of blood collection at Visit 1 is 2 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HepQuant, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

April 20, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • HQ-US-2501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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