An interventional study of Velacur by Sonic Incytes in NAFLD and NASH - Nonalcoholic Steatohepatitis, sponsored by Indiana University. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Indiana University · Not applicable, Interventional, and Diagnostic
The purpose of this study is to prospectively evaluate the utility of Liver Incytes in assessing NAFLD with or without advanced fibrosis in patients seen in liver clinics for suspected NAFLD diagnosis.
The proposed study will evaluate the performance characteristics of LSM as a measure of fibrosis and ACE as a measure of hepatic steatosis by Liver Incytes in patients with different stages of NAFLD. In addition, the diagnostic accuracy of ACE will be compared to CAP and LSM as measured by Liver Incytes to that measured by FibroScan® using liver histology as the reference standard. The performance of these two methods will also be compared to that of non-invasive blood based markers such as APRI, FIB4, and NAFLD fibrosis score in predicting advanced fibrosis in biopsy proven NAFLD.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
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Exclusion Criteria:
Subject with history of cirrhosis or clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities at screening
Patients with known or suspected Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH) will be scanned with Velacur for assessment of liver fibrosis.
Diagnostic Test: Velacur by Sonic Incytes
liver stiffness measurement
Liver Stiffness Measured by Velacur
Assessing correlation of liver stiffness measurements (LSM) as measured by Velacur to grade of fibrosis on liver histology of patients with NAFLD who underwent standard of care liver biopsy. Results are reported per fibrosis category: F0, F1, F2, F3, and F4.
Time frame: one day
Liver Stiffness Measured by Transient Elastography
Assessing correlation of liver stiffness measurements (LSM) as measured by FibroScan to grade of fibrosis on liver histology of patients with NAFLD who underwent standard of care liver biopsy. Results are reported per fibrosis category: F0, F1, F2, F3, and F4.
Time frame: one day
Correlation of Velacur Measurements to Non-Invasive Blood Markers for Predicting Advanced Fibrosis
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.
Time frame: one day
Of the 36 participants who enrolled in the study, only 21 people had a valid Velacur study and valid ultrasound elasticity imaging. All 36 people completed the study but 15 people were later found to have results that were deemed to not be valid upon review by Sonic Incytes.
| Milestone | Velacur by Sonic Incytes |
|---|---|
| Started | 36 |
| Completed | 21 |
| Not completed | 15 |
| Withdrew: 15 had scans that were determined to be invalid and these are not reported within the results. | 15 |
Assessing correlation of liver stiffness measurements (LSM) as measured by Velacur to grade of fibrosis on liver histology of patients with NAFLD who underwent standard of care liver biopsy. Results are reported per fibrosis category: F0, F1, F2, F3, and F4.
| kPa | Velacur by Sonic Incytes for Stage F0 | Velacur by Sonic Incytes for Stage F1 | Velacur by Sonic Incytes for Stage F2 | Velacur by Sonic Incytes for Stage F3 | Velacur by Sonic Incytes for Stage F4 |
|---|---|---|---|---|---|
| Liver Stiffness Measured by Velacur | 9.8 ± 4.4 | 7.2 ± 2.3 | 7.4 ± 1.6 | 7.5 ± 1.9 | 10.5 ± 5.0 |
Assessing correlation of liver stiffness measurements (LSM) as measured by FibroScan to grade of fibrosis on liver histology of patients with NAFLD who underwent standard of care liver biopsy. Results are reported per fibrosis category: F0, F1, F2, F3, and F4.
| kPa | Velacur by Sonic Incytes for Stage F0 | Velacur by Sonic Incytes for Stage F1 | Velacur by Sonic Incytes for Stage F2 | Velacur by Sonic Incytes for Stage F3 | Velacur by Sonic Incytes for Stage F4 |
|---|---|---|---|---|---|
| Liver Stiffness Measured by Transient Elastography | 11.1 ± 4.3 | 10.1 ± 3.5 | 15.3 ± 8.3 | 7.5 ± 1.9 | 18.2 ± 9.1 |
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.
No measurements were reported for this outcome.
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Velacur by Sonic Incytes | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
A total of 21 people underwent both Velacur and transient elastography via FibroScan and had results considered to be reliable.
| Age, Continuous(years) | Velacur by Sonic Incytes |
|---|---|
| Median | 58 ± 11.9 |
| Sex: Female, Male(Participants) | Velacur by Sonic Incytes |
|---|---|
| Female | 16 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Velacur by Sonic Incytes |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Velacur by Sonic Incytes |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Velacur by Sonic Incytes |
|---|---|
| United States | 21 |
| BMI measured in kg/m^2(kg/m^2) | Velacur by Sonic Incytes |
|---|---|
| Mean | 34.4 ± 7.4 |
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