Validation of Different Methods for HepQuant DuO® Blood Sample Collection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HepQuant DuO Test.
- Who it may be relevant to
- Registry conditions: Healthy Adult Participants, Liver Disease Chronic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- 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.
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07473817 · HQ-US-2501