Last reviewed · How we verify

NCT04576897

Velacur by Sonic Incytes for Portal Hypertension

Completed NA Results posted Last updated 5 September 2023
What this trial tests

NA trial testing Velacur in Portal Hypertension in 70 participants. Completed in 19 April 2022.

Timeline
1 February 2021
Primary endpoint
19 April 2022
19 April 2022

Quick facts

Lead sponsorIndiana University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment70
Start date1 February 2021
Primary completion19 April 2022
Estimated completion19 April 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Indiana University

Who can join

18 and older, any sex, with Portal Hypertension or Chronic Advanced Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

liver stiffness with Velacur
GroupValue95% CI
Participants Without Evidences of Esophageal Varices9.6± 3.9
Participants With Evidence of Esophageal Varices10.1± 3.2
liver stiffness with FibroScan
GroupValue95% CI
Participants Without Evidences of Esophageal Varices26.5± 21.9
Participants With Evidence of Esophageal Varices43.3± 23.5
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease Primary · 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

GroupValue95% CI
Participants With Evidence of Esophageal Varices91.2± 37.7
Participants Without Evidence of Esophageal Varices138± 71

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Velacur

Trials testing the same drug.

Other recruiting trials for Portal Hypertension

Currently open trials in the same condition.

Other Indiana University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04576897.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing