Hepatic EncephalopathyNCT04664621
HepQuant to Predict Hepatic Encephalopathy After TIPS
A study testing HepQuant in people with Hepatic Encephalopathy and Cirrhosis, Liver, run by Northwestern University at 1 site in United States.
Trial summary
A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Encephalopathy, Cirrhosis, Liver
- What is being tested?
- HepQuant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over the age of 18 able to provide consent
- Subjects undergoing initial TIPS procedure for the primary indication of treatment of ascites
Who cannot join
- Prisoners
- Pregnant women
- Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
- Subjects taking beta-blocker medications or angiotensin converting enzyme inhibitors
- Subjects with evidence of porto-systemic shunts present on imaging (eg splenorenal shunt)
- Subjects with calculated MELD score >12 based on most recent laboratory values before consent
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- Subjects with prior history of overt hepatic encephalopathy (grade 3-4) that was primary reason for hospitalization. Episodes of hepatic encephalopathy that were the consequence of other precipitating event (such as variceal bleeding or infection) will not be considered exclusionary.
- Subjects with a known sensitivity to albumin preparations, any ingredient in the formulation, or components of the container
- Subjects unable to fast for >5 hours prior to the HepQuant administration or subjects who are unable to drink the oral dose of the cholate (~40mL of liquid).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HepQuant to Predict Hepatic Encephalopathy in Patients Who Receive Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Refractory Ascites - a Pilot Study
A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease.
- Conditions
- Hepatic Encephalopathy, Cirrhosis, Liver
- Being tested
- HepQuant
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepQuantDiagnostic test
Patients undergoing TIPS procedure will receive a HepQuant test prior to and then after TIPS.
| Study group | Role | What they receive |
|---|---|---|
| HepQuant Testing | Experimental | Not described Receives: Diagnostic Test: HepQuant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of Hepatic Encephalopathy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start25 Feb 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Grant expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- HepQuant, LLC
- Responsible party
- Principal investigator, Justin Boike, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664621
- Sponsor's protocol ID
- STU00210205
- Status last verified
- Aug 2022
- First submitted
- 6 Dec 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HepQuant to Predict Hepatic Encephalopathy in Patients Who Receive Transjugular Intrahepatic Portosystemic Shunt (TIPS) for Refractory Ascites - a Pilot Study
- ClinicalTrials.gov ID
- NCT04664621
- Acronym / sponsor ID
- STU00210205
- Conditions
- Hepatic Encephalopathy, Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant expired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- HepQuant, LLC
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 11 Dec 2020 (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.
A pilot study to determine if a simple blood test can predict patients at risk for significant episodes of confusion and disorientation that can occur in patients who receive an artificial shunt through the liver to control complications of liver disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HepQuant Testing | Experimental | Diagnostic Test: HepQuant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects over the age of 18 able to provide consent
- Subjects undergoing initial TIPS procedure for the primary indication of treatment of ascites
Key exclusion criteria (9 listed)
- Prisoners
- Pregnant women
- Subjects undergoing TIPS placement as part of an investigational study outside of usual clinical care
- Subjects taking beta-blocker medications or angiotensin converting enzyme inhibitors
- Subjects with evidence of porto-systemic shunts present on imaging (eg splenorenal shunt)
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 |
|---|---|---|
| HepQuantPatients undergoing TIPS procedure will receive a HepQuant test prior to and then after TIPS. | Diagnostic test | HepQuant Testing |
Primary outcome
Onset of Hepatic Encephalopathy
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HepQuant in people with Hepatic Encephalopathy and Cirrhosis, Liver, run by Northwestern University at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 9 Aug 2022. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Onset of Hepatic Encephalopathy (time frame: 6 months). 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 9 Aug 2022.