Serum Regucalcin Level and Chronic Hepatitis B

Chronic Hepatitis b Clinical Trial

Official title:

Efficacy of Serum Regucalcin Level in Detecting Fibrosis in Chronic Hepatitis B Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435599
• Other study ID #: 10542
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2022
• Source: Konya Meram State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Description:

Chronic hepatitis B (CHB) infection continues to be an important health problem due to its high morbidity and mortality. For this reason, it is very important to determine the appropriate timing to start antiviral therapy in patients with CHB infection and to evaluate the stage of liver fibrosis in the treatment follow-up. Liver biopsy is the gold standard for detecting liver fibrosis. Although it is generally accepted to be a safe procedure, it can cause some serious complications. For this reason, in recent years, many studies have been conducted on new noninvasive tests in the evaluation of liver fibrosis. One of them is the serum regucalcin level. Studies have shown that serum regucalcin levels increase in liver damage, but there is no study in the literature comparing liver fibrosis and serum regucalcin levels in CHB infection. This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being followed up with a diagnosis of chronic hepatitis B

• Not having a known history of liver disease who applied to our outpatient clinic for other reasons

• Having a liver biopsy

• =18 years

Exclusion Criteria:

• <18 years

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Diagnostic Test:
• Serum regucalcin level
During routine outpatient controls, serum regucalcin level will be measured from the rest of the blood taken for examinations.

Locations

Country	Name	City	State
Turkey	Konya Training and Research Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Meram State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Wei X, Yu H, Zhao P, Xie L, Li L, Zhang J. Serum regucalcin is a useful indicator of liver injury severity in patients with hepatitis B virus-related liver diseases. Braz J Med Biol Res. 2019 Sep 30;52(10):e8845. doi: 10.1590/1414-431X20198845. eCollection 2019. — View Citation

Yamaguchi M, Isogai M, Shimada N. Potential sensitivity of hepatic specific protein regucalcin as a marker of chronic liver injury. Mol Cell Biochem. 1997 Feb;167(1-2):187-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of serum regucalcin levels with liver fibrosis levels	We grouped chronic hepatitis b patients as mild fibrosis (stage 1-2) and moderate fibrosis (stage 3-4) according to the fibrosis stage at liver biopsy stage. We selected healthy volunteers without liver disease as the control group. We will measure the serum regucalcin level in these 3 groups and make a comparison between the groups. We want to show the relationship between serum regucalcin level and fibrosis level in chronic hepatitis b.	Performing liver biopsies: 3 months, data collection: 1 month, writing the article: 1 month