N/A
N=70
Velacur by Sonic Incytes for Portal Hypertension
Portal Hypertension · Chronic Advanced Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT04576897 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) — 9.6; 10.1; 26.5; 43.3 kPa
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Velacur (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) |
9.6; 10.1; 26.5; 43.3 | — |
| PRIMARY Platelet Count for Participants With Compensated Advanced Chronic Liver Disease |
91.2; 138 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04576897). 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.