Phase 3
Completed N=20
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Source: ClinicalTrials.gov NCT02523196 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1) — 0.104; 0.092; 0.099 min-1
◆ Published Evidence
Established
78citations · ~6 / year
Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial.
Summary
This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient testing in patients with liver disease.
Linked Publications
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Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1) |
0.104; 0.092; 0.099 | — |
| PRIMARY Results of HepQuant SHUNT Test: Systemic Clearance |
463; 384; 427 | — |
| PRIMARY Results of HepQuant SHUNT Test: Apparent Portal Clearance |
1538; 975; 1285 | — |
| PRIMARY Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate |
5.30; 4.47; 4.92 | — |
| PRIMARY Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate |
17.83; 11.11; 14.81 | — |
| PRIMARY Results of HepQuant SHUNT Test: SHUNT |
29.08; 47.50; 37.37 | — |
| PRIMARY Results of HepQuant SHUNT Test: DSI Score |
14.64; 20.68; 17.36 | — |
| PRIMARY Results of HepQuant SHUNT Test: STAT |
0.61; 1.29; 0.92 | — |
| SECONDARY Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures. |
3.9; .35; 4.2; .5; 5.9; 1.25 | — |
| SECONDARY Hours for Test |
4; 18; 5; 2; 3; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Liver disease patient scheduled to have an Hepatic Venous Pressure Gradient (HVPG) procedure
- At time of enrollment, being between the ages of 18 and 75
Exclusion Criteria
- Concomitant treatment with both a beta blocker and an ACE inhibitor
- Concurrent hepatic malignancy. Patients with a history of treated HCC can be included if there is no evidence of recurrent disease at the time of this study.
- Unstable angina or history of myocardial infarction or congestive heart failure within 6 months prior to enrollment into this study
- Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min/1.73m2)
- Crohn's disease or any active intestinal inflammatory condition
- Having had an ileal resection
- Diabetic Gastroparesis
- Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed prior to HQ SHUNT testing.
- Inability to consent for one's self
Data sourced from ClinicalTrials.gov (NCT02523196) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.