Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573190
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Liver Status and Presence of MASLDMASH in Patients With Chronic Hepatitis B
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Value of Fibroscan in Assessing the Liver Status and Presence of MASLDMASH in Patients With Chronic Hepatitis B and Monitoring Changes by Antiviral Therapy Faraday Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Faraday
Brief Summary:
The aim of the study was to evaluate the consistency between liver biopsy and Liver Stiffness Measurement LSM for fibrosis and controlled attenuation parameter CAP for steatosis in FibroScan in patients with chronic hepatitis B The secondary aim of the study was to demonstrate the efficacy of FibroScan for following the CHB patients at 12th month of antiviral therapy
The study was prospectively planned in four different centers Patients with HBsAg positivity for more than six months and HBV-DNA2000 IUmL underwent liver biopsy and FibroScan together within two week FibroScan was performed twice before the antiviral therapy and one year later
The study was prospectively planned in four different centers Patients with HBsAg positivity for more than six months and HBV-DNA2000 IUmL underwent liver biopsy and FibroScan together within two week FibroScan was performed twice before the antiviral therapy and one year later
Detailed Description:
Patients aged 18 years and older with HBsAg positivity for more than six months and HBV-DNA level 2000 IUml were included in the study The exclusion criteria were established as presence of cirrhosis alcohol consumption 140 gweek for women and 210 gweek for men hepatitis C hepatitis D andor HIV coinfections
The baseline characteristics including patient demographics BMI comorbidities LSM and CAP via transient elastography FibroScan liver ultrasound HBV serology platelet count ALT HBV viral load
All patients underwent liver biopsy before initiating antiviral therapy with a maximum interval of two week between liver biopsy and the FibroScan
Transient elastography was performed by a certified operator using the M probe for patients with skin to capsule distance 25 cm or an XL probe for patients with skin to capsule distance 25 cm Patients were fasted for 2 h before FibroScan At least 10 successful measurements were performed and recorded
Fibrosis stage by Liver Stiffness Measurement LSM and steatosis by Controlled Attenuation Parameter CAP were investigated on FibroScan for MASLD and MASH Obese or diabetic patients with a CAP value 240 dBm were considered MASLD Patients with normal BMI and nondiabetic patients had at least two risk factors for metabolic dysfunction were also considered to have MASLD Patients with MASLD and concomitant necroinflammation in the liver were considered as MASH Necroinflammation was considered as LSM 72 kPa in patients with MASLD or LSM 55 kPa in patients with liver injury histologic andor ALTNSU
The study protocol was approved by the Ethics Committee of Dicle University Protocol number 2022261 The IBM SPSS 210 statistical software for Windows was used for the statistical evaluation of the research data The measurable variables were presented as the mean standard deviation SD while the categorical variables were presented as the number and percentage Spearmans rho correlation analysis was performed to determine the relationship between the variables The hypotheses were bidirectional and p 005 was considered statistically significant
The baseline characteristics including patient demographics BMI comorbidities LSM and CAP via transient elastography FibroScan liver ultrasound HBV serology platelet count ALT HBV viral load
All patients underwent liver biopsy before initiating antiviral therapy with a maximum interval of two week between liver biopsy and the FibroScan
Transient elastography was performed by a certified operator using the M probe for patients with skin to capsule distance 25 cm or an XL probe for patients with skin to capsule distance 25 cm Patients were fasted for 2 h before FibroScan At least 10 successful measurements were performed and recorded
Fibrosis stage by Liver Stiffness Measurement LSM and steatosis by Controlled Attenuation Parameter CAP were investigated on FibroScan for MASLD and MASH Obese or diabetic patients with a CAP value 240 dBm were considered MASLD Patients with normal BMI and nondiabetic patients had at least two risk factors for metabolic dysfunction were also considered to have MASLD Patients with MASLD and concomitant necroinflammation in the liver were considered as MASH Necroinflammation was considered as LSM 72 kPa in patients with MASLD or LSM 55 kPa in patients with liver injury histologic andor ALTNSU
The study protocol was approved by the Ethics Committee of Dicle University Protocol number 2022261 The IBM SPSS 210 statistical software for Windows was used for the statistical evaluation of the research data The measurable variables were presented as the mean standard deviation SD while the categorical variables were presented as the number and percentage Spearmans rho correlation analysis was performed to determine the relationship between the variables The hypotheses were bidirectional and p 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None