21 and older, any sex, with NAFLD or NASH - Nonalcoholic Steatohepatitis. 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 Measured by VelacurPrimary· one day
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.
Group
Value
95% CI
Velacur by Sonic Incytes for Stage F0
9.8
± 4.4
Velacur by Sonic Incytes for Stage F1
7.2
± 2.3
Velacur by Sonic Incytes for Stage F2
7.4
± 1.6
Velacur by Sonic Incytes for Stage F3
7.5
± 1.9
Velacur by Sonic Incytes for Stage F4
10.5
± 5.0
Liver Stiffness Measured by Transient ElastographyPrimary· one day
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.
Group
Value
95% CI
Velacur by Sonic Incytes for Stage F0
11.1
± 4.3
Velacur by Sonic Incytes for Stage F1
10.1
± 3.5
Velacur by Sonic Incytes for Stage F2
15.3
± 8.3
Velacur by Sonic Incytes for Stage F3
7.5
± 1.9
Velacur by Sonic Incytes for Stage F4
18.2
± 9.1
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 21 August 2023
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/NCT04576923.