Liver DiseasePhase 3NCT02523196

Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)

A Phase 3 study testing HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate) and Hepatic Venous Pressure Gradient (HVPG) in people with Liver Disease, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Liver Disease
What is being tested?: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate) and Hepatic Venous Pressure Gradient (HVPG)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Mar 2016to 23 Feb 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver (Leprino Building)
Aurora, Colorado, 80045

Other trials in United States

About this study

Read the detailed description

The goal of this study is to demonstrate the HQ-SHUNT is safe, simple to administer, noninvasive, cost-effective, and well tolerated by patients. This study will compare the HQ-SHUNT to Hepatic Venous Pressure Gradient (HVPG) testing. In this study, 100 consecutive patients with various etiologies of liver disease who have undergone technically successful HVPG testing as standard of care will also undergo HQ-SHUNT testing.

Conditions: Liver Disease
Being tested: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate), Hepatic Venous Pressure Gradient (HVPG)
Keywords: Hepatic Venous Pressure Gradient (HVPG) testing, HepQuant-SHUNT, Liver Function
Medical subject headings: Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)Drug
Also called HQ-SHUNT
The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease
Hepatic Venous Pressure Gradient (HVPG)Device
Also called (HVPG)
Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease

Study groups in NCT02523196
Study group	Role	What they receive
(HVPG) and HepQuant-SHUNT (HQ-Shunt)	Other	Successful Hepatic Venous Pressure Gradiant (HVPG) testing is required prior to administration of the HepQuant-SHUNT test. Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices. Receives: Drug: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate); Device: Hepatic Venous Pressure Gradient (HVPG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1)
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Measured: Up to 90 minutes
Results of HepQuant SHUNT Test: Systemic Clearance
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. Systemic Clearance (13C-CA; ml min-1)
Measured: Up to 90 minutes
Results of HepQuant SHUNT Test: Apparent Portal Clearance
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Measured: Up to 90 minutes
Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Measured: Up to 90 minutes
Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Measured: Up to 90 minutes
Results of HepQuant SHUNT Test: SHUNT
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
SHUNT% is The percent of the oral dose of cholate that escapes hepatic extraction
Measured: Up to 90 minutes
Results of HepQuant SHUNT Test: DSI Score
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
DSI range is from 0 to 50. 0 implies no disease; 50 implies severe end-stage disease.
Measured: Up to 90 minutes
Results of HepQuant SHUNT Test: STAT
Compare HepQuant STAT test from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. HepQuant STAT is a simple "drink and draw" blood-based clearance test that quantifies hepatic impairment from early through late stages of disease.
Measured: 60 minutes

Secondary outcomes (2)

Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Overall experience and willingness to repeat 0-10 Scale 0 being no pain, 10 being severe pain 0 being no discomfort, 10 being severe discomfort 0 being no interference with daily life, 10 being unable to carry on activities 0 being very negative experience, 10 being very positive experience 0 being definitely not wanting to have the test again, 10 being very willing to have the test again
Measured: Immediately post HepQuant SHUNT test (Baseline up to Day 60)
Hours for Test
Number of hours it took for subjects to complete each test
Measured: Baseline, up to Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201623 Feb 2017

First posted14 Aug 2015 (estimated)
Study startMar 2016
Primary completion23 Feb 2017
Study completion23 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Liver DiseaseStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
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: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02523196
Sponsor's protocol ID: 15-0520
Other IDs: UL1TR001082
Status last verified: Aug 2021
First submitted: 3 Aug 2015
Last updated: 9 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Lauriski S, Curto TM, Stoddard A, Wright EC; HALT-C Trial Group. 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. Hepatology. 2012 Apr;55(4):1019-29. doi: 10.1002/hep.24752. Epub 2012 Mar 1.
PubMed 22030902

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
ClinicalTrials.gov ID: NCT02523196
Acronym / sponsor ID: 15-0520
Conditions: Liver Disease
Keywords: Hepatic Venous Pressure Gradient (HVPG) testing, HepQuant-SHUNT, Liver Function
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: Mar 2016
Primary completion: 23 Feb 2017 (actual)
Study completion: 23 Feb 2017 (actual)
First posted: 14 Aug 2015 (estimated)
Results: Posted 5 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
(HVPG) and HepQuant-SHUNT (HQ-Shunt)	Other	Drug: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate), Device: Hepatic Venous Pressure Gradient (HVPG)Successful Hepatic Venous Pressure Gradiant (HVPG) testing is required prior to administration of the HepQuant-SHUNT test. Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (9 listed)

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

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-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)Also: HQ-SHUNTThe HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease	Drug	(HVPG) and HepQuant-SHUNT (HQ-Shunt)
Hepatic Venous Pressure Gradient (HVPG)Also: (HVPG)Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease	Device	(HVPG) and HepQuant-SHUNT (HQ-Shunt)

Primary outcome

Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1)
Time frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Results of HepQuant SHUNT Test: Systemic Clearance
Time frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. Systemic Clearance (13C-CA; ml min-1)
Results of HepQuant SHUNT Test: Apparent Portal Clearance
Time frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate
Time frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate
Time frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Results of HepQuant SHUNT Test: SHUNT
Time frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. SHUNT% is The percent of the oral dose of cholate that escapes hepatic extraction
Results of HepQuant SHUNT Test: DSI Score
Time frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. DSI range is from 0 to 50. 0 implies no disease; 50 implies severe end-stage disease.
Results of HepQuant SHUNT Test: STAT
Time frame: 60 minutes
Compare HepQuant STAT test from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. HepQuant STAT is a simple "drink and draw" blood-based clearance test that quantifies hepatic impairment from early through late stages of disease.

2 secondary outcomes

Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Time frame: Immediately post HepQuant SHUNT test (Baseline up to Day 60)
Hours for Test
Time frame: Baseline, up to Day 60

Results and safety

Results posted to the registry on 5 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hepatic Venous Pressure Gradient (HVPG) and HepQuant-SHUNT (HQ	20	20

Primary outcome: Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1)

Time frame: Up to 90 minutes. Mean (Standard Deviation). Unit: min-1

Measure	HVPG <6 mmHg n = 11	HVPG ≥6 mmHg n = 9	All Patients n = 20
Value	0.104 (0.017)	0.092 (0.023)	0.099 (0.020)

Primary outcome: Results of HepQuant SHUNT Test: Systemic Clearance

Time frame: Up to 90 minutes. Mean (Standard Deviation). Unit: (13C-CA; ml min-1)

Measure	HVPG <6 mmHg n = 11	HVPG ≥6 mmHg n = 9	All Patients n = 20
Value	463 (161)	384 (137)	427 (152)

Primary outcome: Results of HepQuant SHUNT Test: Apparent Portal Clearance

Time frame: Up to 90 minutes. Mean (Standard Deviation). Unit: d4-CA; ml min-1

Measure	HVPG <6 mmHg n = 11	HVPG ≥6 mmHg n = 9	All Patients n = 20
Value	1538 (525)	975 (464)	1285 (564)

Primary outcome: Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate

Time frame: Up to 90 minutes. Mean (Standard Deviation). Unit: ml min-1 kg-1

Measure	HVPG <6 mmHg n = 11	HVPG ≥6 mmHg n = 9	All Patients n = 20
Value	5.30 (1.09)	4.47 (1.43)	4.92 (1.29)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hepatic Venous Pressure Gradient (HVPG)	0 of 20 (0%)	0 of 20 (0%)	0 of 20
HepQuant-SHUNT (HQ-Shunt)	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): Study did not reach enrollment goal of 110, therefore analysis was limited due to low power

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22030902Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Lauriski S, Curto TM, Stoddard A, Wright EC; HALT-C Trial Group. 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. Hepatology. 2012 Apr;55(4):1019-29. doi: 10.1002/hep.24752. Epub 2012 Mar 1.
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. This study is not recruiting at the moment.

Amanda Wieland, MD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1) (time frame: Up to 90 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02523196, which also lists 1 linked publication.

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 9 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.