Validation of Different Methods for HepQuant DuO® Blood Sample Collection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHepQuant, LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
HepQuant DuO Test
DeviceHepQuant 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Blood Sampling1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
From screening to completion of blood collection at Visit 1 is 2 weeks.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: