Trial Outcomes & Findings for Velacur by Sonic Incytes for Portal Hypertension (NCT NCT04576897)

Last Updated: 2023-09-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

one day

Results posted on

2023-09-05

Participant Flow

70 participants enrolled in the study. The images from the Velacur device for all of the subjects were reviewed by the company. Only 33 of the enrolled participants had a valid Velacur study so results are reported only for these 33 participants. The remaining 37 participants were considered to have withdrawn from the study.

Participant milestones

Participant milestones
Measure	Liver Incytes Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Liver Incytes. Liver Incytes: Ultrasound elasticity imaging
Overall Study STARTED	70
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Liver Incytes Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Liver Incytes. Liver Incytes: Ultrasound elasticity imaging
Overall Study 37 scans were determined by the sponsor to be invalid.	37

Baseline Characteristics

Velacur by Sonic Incytes for Portal Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liver Incytes n=33 Participants Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Liver Incytes.
Age, Continuous	58 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants
Velacur, liver stiffness	9.9 kPa STANDARD_DEVIATION 3.4 • n=5 Participants
Velacur, liver steatosis	313 dB/m STANDARD_DEVIATION 76 • n=5 Participants
transient elastography via FibroScan, liver stiffness	37.8 kPa STANDARD_DEVIATION 24.1 • n=5 Participants
transient elastography via FibroScan, liver steatosis	262 dB/m STANDARD_DEVIATION 73 • n=5 Participants

PRIMARY outcome

Timeframe: one day

Outcome measures

Outcome measures
Measure	Participants Without Evidences of Esophageal Varices n=10 Participants Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur by Sonic Incyes and transient elastography via FibroScan. All participants will have also undergone esophagogastroduodenoscopy (EGD). Results will be compared for participants with and without varices found in the EGD.	Participants With Evidence of Esophageal Varices n=23 Participants Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur by Sonic Incyes and transient elastography via FibroScan. All participants will have also undergone esophagogastroduodenoscopy (EGD). Results will be compared for participants with and without varices found in the EGD.
Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) liver stiffness with Velacur	9.6 kPa Standard Deviation 3.9	10.1 kPa Standard Deviation 3.2
Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD) liver stiffness with FibroScan	26.5 kPa Standard Deviation 21.9	43.3 kPa Standard Deviation 23.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Participants Without Evidences of Esophageal Varices n=23 Participants Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur by Sonic Incyes and transient elastography via FibroScan. All participants will have also undergone esophagogastroduodenoscopy (EGD). Results will be compared for participants with and without varices found in the EGD.	Participants With Evidence of Esophageal Varices n=10 Participants Patients with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplantation will be scanned with Velacur by Sonic Incyes and transient elastography via FibroScan. All participants will have also undergone esophagogastroduodenoscopy (EGD). Results will be compared for participants with and without varices found in the EGD.
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease	91.2 in 100000 per microliter of blood Standard Deviation 37.7	138 in 100000 per microliter of blood Standard Deviation 71

OTHER_PRE_SPECIFIED outcome

Timeframe: one day

Population: During the course of this study, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement

This was initially included in our study protocol as an outcome measurement. However, we realized that these markers were not being routinely collected and the data are simply not available. Therefore, no outcome data are or can be included for this measurement.

Outcome measures

Outcome data not reported

Adverse Events

Liver Incytes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Samer Gawrieh

Indiana University

Phone: 317-278-9326

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place