Chronic Hepatitis bNCT05435599
Serum Regucalcin Level and Chronic Hepatitis B
A study testing Serum regucalcin level in people with Chronic Hepatitis b and Liver Fibrosis, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis b, Liver Fibrosis
- What is being tested?
- Serum regucalcin level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <18 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: Efficacy of Serum Regucalcin Level in Detecting Fibrosis in Chronic Hepatitis B Infection
This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.
Read the 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.
- Conditions
- Chronic Hepatitis b, Liver Fibrosis
- Being tested
- Serum regucalcin level
- Keywords
- hepatitis b, fibrosis, regucalcin, liver
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis, Hepatitis B, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum regucalcin levelDiagnostic test
During routine outpatient controls, serum regucalcin level will be measured from the rest of the blood taken for examinations.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hepatitis B | Other | Measurement of serum regucalcin level Receives: Diagnostic Test: Serum regucalcin level |
| Healthy Volunteers | Other | Measurement of serum regucalcin level Receives: Diagnostic Test: Serum regucalcin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Performing liver biopsies: 3 months, data collection: 1 month, writing the article: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients undergoing liver biopsy for chronic hepatitis b
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Çölkesen, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435599
- Sponsor's protocol ID
- 10542
- Status last verified
- Jun 2022
- First submitted
- 6 Dec 2021
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31576907Yamaguchi 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.
PubMed 9059996
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serum Regucalcin Level in Detecting Fibrosis in Chronic Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT05435599
- Acronym / sponsor ID
- 10542
- Conditions
- Chronic Hepatitis b, Liver Fibrosis
- Keywords
- hepatitis b, fibrosis, regucalcin, liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients undergoing liver biopsy for chronic hepatitis b
| Arm | Type | Receives |
|---|---|---|
| Chronic Hepatitis B | Other | Diagnostic Test: Serum regucalcin levelMeasurement of serum regucalcin level |
| Healthy Volunteers | Other | Diagnostic Test: Serum regucalcin levelMeasurement of serum regucalcin level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum regucalcin levelDuring routine outpatient controls, serum regucalcin level will be measured from the rest of the blood taken for examinations. | Diagnostic test | Chronic Hepatitis B, Healthy Volunteers |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Background: PubMed 31576907Wei 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.
- Background: PubMed 9059996Yamaguchi 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Hepatitis b
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum regucalcin level in people with Chronic Hepatitis b and Liver Fibrosis, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435599, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.