Portal HypertensionNCT04576897

Velacur by Sonic Incytes for Portal Hypertension

A study testing Velacur in people with Portal Hypertension and Chronic Advanced Liver Disease, run by Indiana University 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 is a cross sectional study that evaluates the relationship between LSM (liver stiffness measurement) by Liver Incytes in patients with cACLD (compensated advanced chronic liver disease) and manifestations of portal hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Portal Hypertension, Chronic Advanced Liver Disease
What is being tested?: Velacur
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2021to 19 Apr 2022
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged 18 years or older
Ability to provide informed consent
Planned standard of care upper endoscopy to screen for varices
Planned standard of care transjugular liver biopsy with portal pressure measurement

Who cannot join

Inability or refusal to provide informed consent
Fasting for less than three hours prior to the scan
Subject is a pregnant or lactating female
Subject with current, significant alcohol consumption
Patients with a pacemaker or defibrillator
Acute hepatitis defined as AST/ALT > 500 U/L
Ascites
post liver transplantation

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University Division of Gastroenterolgy and Hepatology
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Liver Stiffness Measurement Using Liver Incytes

Read the detailed description

The purpose of this study is to assess the severity of portal hypertension in people with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplant by measuring liver stiffness with the Liver Incytes device (Velacur) and comparing the performance of LSM (liver stiffness measurement) via Velcaur and transient elastography via FibroScan to esophageal varices.

Conditions: Portal Hypertension, Chronic Advanced Liver Disease
Being tested: Velacur
Medical subject headings: Hypertension, Portal

What participants receive

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

VelacurDiagnostic test
Ultrasound elasticity imaging

Study groups in NCT04576897
Study group	Role	What they receive
Velacur by Sonic Incytes	Experimental	Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur. Receives: Diagnostic Test: Velacur

What is being measured

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

Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)
Comparing the performance of Velacur by Sonic Incytes to transient elastography via FibroScan® in the same patient population to determine if either test is more accurate in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices.
Measured: one day
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease
Comparing the platelet count in the same patient population to determine Velacur's accuracy in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices
Measured: one day

Timeline

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

1 Feb 202119 Apr 2022

First posted6 Oct 2020
Study start1 Feb 2021
Primary completion19 Apr 2022
Study completion19 Apr 2022

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.
Other trials for Portal HypertensionStudies of the same condition, open and under way.
More trials run by Indiana 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
Model description: All participants will undergo quantitative ultrasound with Velacur by Sonic Incytes by a certified technician.
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04576897
Sponsor's protocol ID: LI for Portal Hypertenstion
Other IDs: 2009698702
Status last verified: Aug 2023
First submitted: 30 Sep 2020
Last updated: 5 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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?

See locations

RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy

All Portal Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Liver Stiffness Measurement Using Liver Incytes
ClinicalTrials.gov ID: NCT04576897
Acronym / sponsor ID: LI for Portal Hypertenstion
Conditions: Portal Hypertension, Chronic Advanced Liver Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Collaborators: Sonic Incytes
Study start: 1 Feb 2021 (actual)
Primary completion: 19 Apr 2022 (actual)
Study completion: 19 Apr 2022 (actual)
First posted: 6 Oct 2020 (actual)
Results: Posted 5 Sep 2023

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
Model description: All participants will undergo quantitative ultrasound with Velacur by Sonic Incytes by a certified technician.

Arm	Type	Receives
Velacur by Sonic Incytes	Experimental	Diagnostic Test: VelacurPatients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur.

Who may qualify

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

Key inclusion criteria (4 listed)

Adults aged 18 years or older
Ability to provide informed consent
Planned standard of care upper endoscopy to screen for varices
Planned standard of care transjugular liver biopsy with portal pressure measurement

Key exclusion criteria (8 listed)

Inability or refusal to provide informed consent
Fasting for less than three hours prior to the scan
Subject is a pregnant or lactating female
Subject with current, significant alcohol consumption
Patients with a pacemaker or defibrillator

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
VelacurUltrasound elasticity imaging	Diagnostic test	Velacur by Sonic Incytes

Primary outcome

Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)
Time frame: one day
Comparing the performance of Velacur by Sonic Incytes to transient elastography via FibroScan® in the same patient population to determine if either test is more accurate in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices.
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease
Time frame: one day
Comparing the platelet count in the same patient population to determine Velacur's accuracy in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices

Results and safety

Results posted to the registry on 5 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liver Incytes	70	33

Primary outcome: Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)

Time frame: one day. Mean (Standard Deviation). Unit: kPa

Measure	Participants Without Evidences of Esophageal Varices n = 10	Participants With Evidence of Esophageal Varices n = 23
liver stiffness with Velacur	9.6 (3.9)	10.1 (3.2)
liver stiffness with FibroScan	26.5 (21.9)	43.3 (23.5)

Primary outcome: Platelet Count for Participants With Compensated Advanced Chronic Liver Disease

Time frame: one day. Mean (Standard Deviation). Unit: in 100000 per microliter of blood

Measure	Participants With Evidence of Esophageal Varices n = 23	Participants Without Evidence of Esophageal Varices n = 10
Value	91.2 (37.7)	138 (71)

Adverse events

Time frame: Adverse events were collected for the duration of study participation. This is a minimal risk study with only one study visit lasting less than one hour.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liver Incytes	0 of 70 (0%)	0 of 70 (0%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Portal Hypertension

RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy

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.

Samer Gawrieh, MD principal investigator

Indiana University

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

Questions about this trial

What is this clinical trial studying?

A study testing Velacur in people with Portal Hypertension and Chronic Advanced Liver Disease, run by Indiana 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 4 inclusion and 8 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 5 Sep 2023. 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?

Yes. Results are posted in the registry (first posted 5 Sep 2023). 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?

Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) (time frame: one day). The study lists 2 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 NCT04576897.

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 5 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.