Healthy Adult ParticipantsNCT07473817
Validation of Different Methods for HepQuant DuO® Blood Sample Collection
An observational study of Healthy Adult Participants and Liver Disease Chronic, run by HepQuant, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Liver Disease Chronic
- What is being tested?
- HepQuant DuO Test
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2026to 18 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- HepQuant DuO Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HepQuant DuO Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From screening to completion of blood collection at Visit 1 is 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start18 Sep 2026 (estimated)
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HepQuant, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473817
- Sponsor's protocol ID
- HQ-US-2501
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Different Methods for HepQuant DuO® Blood Sample Collection
- ClinicalTrials.gov ID
- NCT07473817
- Acronym / sponsor ID
- HQ-US-2501
- Conditions
- Healthy Adult Participants, Liver Disease Chronic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HepQuant, LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (estimated)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Sep 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Sampling | – | Device: HepQuant DuO TestParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepQuant DuO TestHepQuant 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. | Device | Blood Sampling |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult Participants and Liver Disease Chronic, run by HepQuant, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.