Serum Regucalcin Level and Chronic Hepa… | Clinical Trial

Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Liver Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum regucalcin level

Diagnostic Test

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

Primary outcomes

Comparison of serum regucalcin levels with liver fibrosis levels

Time frame: Performing liver biopsies: 3 months, data collection: 1 month, writing the article: 1 month

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.

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2021
First posted: Jun 28, 2022
Registry last updated: Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed