NCT07473817

Validation of Different Methods for HepQuant DuO® Blood Sample Collection

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: HepQuant, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Participants
• Liver Disease Chronic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-10-20
• Completion: 2027-04-20
• First posted: 2026-03-16
• Last updated: 2026-03-16