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Serum Regucalcin Level and Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis b, Liver Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serum regucalcin level
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Hepatitis b focused on measuring hepatitis b, fibrosis, regucalcin, liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Konya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Chronic Hepatitis B

Healthy Volunteers

Arm Description

Measurement of serum regucalcin level

Measurement of serum regucalcin level

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2021
Last Updated
June 23, 2022
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05435599
Brief Title
Serum Regucalcin Level and Chronic Hepatitis B
Official Title
Efficacy of Serum Regucalcin Level in Detecting Fibrosis in Chronic Hepatitis B Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis b, Liver Fibrosis
Keywords
hepatitis b, fibrosis, regucalcin, liver

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients undergoing liver biopsy for chronic hepatitis b
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Hepatitis B
Arm Type
Other
Arm Description
Measurement of serum regucalcin level
Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
Measurement of serum regucalcin level
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum regucalcin level
Intervention Description
During routine outpatient controls, serum regucalcin level will be measured from the rest of the blood taken for examinations.
Primary Outcome Measure Information:
Title
Comparison of serum regucalcin levels with liver fibrosis levels
Description
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.
Time Frame
Performing liver biopsies: 3 months, data collection: 1 month, writing the article: 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Konya Training and Research Hospital
City
Konya
ZIP/Postal Code
42090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31576907
Citation
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.
Results Reference
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PubMed Identifier
9059996
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. doi: 10.1023/a:1006859121897.
Results Reference
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Serum Regucalcin Level and Chronic Hepatitis B

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