Chronic Hepatitis BNCT04759521
Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography
An observational study of Chronic Hepatitis B and Sonoelastography, run by Seyhmus Kavak at 1 site in Turkey (Türkiye).
Trial summary
The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B, Sonoelastography, Fibrosis, Liver
- How many people
- 253 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2019to 18 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: A total of 253 patients with CHB and inactive hepatitis B surface antigen (HBsAg) carriers who presented to the Infectious Diseases outpatient clinic were included in the study. In addition, a healthy control group of 30 people was included.
Who may be able to join
- Being infected with the hepatitis B virus,
- > 18 years old
- < 64 years old
Who cannot join
- Co-infection with hepatitis C or D
- Have chronic or acute fulminant liver disease
- Have DM disease
- Hypertriglyceridemia, obesity, grade2 and higher hepatosteatosis,
- Long-term drug use, alcohol intake that may damage the liver
- Under the age of eighteen
- Over sixty-five years old
- Transplantation patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlik Bilimleri Üniversitesi Training and Research Hospital
Diyarbakır, 21600
About this study
Official title: Evaluation of Liver Fibrosis in Chronic Hepatitis B Patients With 2D Shear Wave Elastography With Propagation Map: A Single Center Study
The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in patients with CHB and determine the suitability of 2D-SWE for use instead of liver biopsy by evaluating fibrosis before and after treatment.
Read the detailed description
A total of 253 patients with CHB and inactive HBsAg carriers as well as a control group of 30 healthy individuals were included in the study between January 2019 and October 2020. Liver stiffness measurements with 2D-SWE, fibrosis-4 (FIB-4) and aspartate aminotransferase to platelet ratio index (APRI) scoring and additional liver biopsy in patients with CHB were performed in all cases with the help of the propagation map. Depending on the degree of fibrosis, liver stiffness was measured again at 24 and 48 weeks in patients who received antiviral therapy. Spearman rank correlation test was used for analysing correlation between variables, and receiver operating curve analysis was used to evaluate diagnostic performance in terms of fibrosis.
- Conditions
- Chronic Hepatitis B, Sonoelastography, Fibrosis, Liver
- Keywords
- Shear wave elastography, Propagation map, Chronic Hepatitis, Liver fibrosis
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Inactive HBsAg carriers were patients with HBsAg positivity for more than 6 months | |
| Group 2 | Patients diagnosed with chronic hepatitis B were patients with HBsAg positivity for more than 6 months | |
| Group 3 | The control group was composed of healthy individuals who were not infected with hepatitis B virus and did not fit any exclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of liver stiffness levels of group 1 and group 2 patients
Liver stiffness levels of group 1 and group 2 patients were compared by measuring in kPa and m / s using 2D-SWE technique. Possible increase and decrease values in liver stiffness measurements were calculated at 24 and 48 weeks in subjects who received antiviral therapy.
Measured: 1st week, 24th week and 48th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start3 Jan 2019
- Primary completion30 Oct 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 253 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seyhmus Kavak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyhmus Kavak, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759521
- Sponsor's protocol ID
- 2019/215
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver Fibrosis in Chronic Hepatitis B Patients With 2D Shear Wave Elastography With Propagation Map: A Single Center Study
- ClinicalTrials.gov ID
- NCT04759521
- Acronym / sponsor ID
- 2019/215
- Conditions
- Chronic Hepatitis B, Sonoelastography, Fibrosis, Liver
- Keywords
- Shear wave elastography, Propagation map, Chronic Hepatitis, Liver fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Seyhmus KavakUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 18 Feb 2021 (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.
The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in patients with CHB and determine the suitability of 2D-SWE for use instead of liver biopsy by evaluating fibrosis before and after treatment.
Detailed description
A total of 253 patients with CHB and inactive HBsAg carriers as well as a control group of 30 healthy individuals were included in the study between January 2019 and October 2020. Liver stiffness measurements with 2D-SWE, fibrosis-4 (FIB-4) and aspartate aminotransferase to platelet ratio index (APRI) scoring and additional liver biopsy in patients with CHB were performed in all cases with the help of the propagation map. Depending on the degree of fibrosis, liver stiffness was measured again at 24 and 48 weeks in patients who received antiviral therapy. Spearman rank correlation test was used for analysing correlation between variables, and receiver operating curve analysis was used to evaluate diagnostic performance in terms of fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Inactive HBsAg carriers were patients with HBsAg positivity for more than 6 months |
| Group 2 | – | –Patients diagnosed with chronic hepatitis B were patients with HBsAg positivity for more than 6 months |
| Group 3 | – | –The control group was composed of healthy individuals who were not infected with hepatitis B virus and did not fit any exclusion criteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 253 patients with CHB and inactive hepatitis B surface antigen (HBsAg) carriers who presented to the Infectious Diseases outpatient clinic were included in the study. In addition, a healthy control group of 30 people was included.
Key inclusion criteria (3 listed)
- Being infected with the hepatitis B virus,
- > 18 years old
- < 64 years old
Key exclusion criteria (8 listed)
- Co-infection with hepatitis C or D
- Have chronic or acute fulminant liver disease
- Have DM disease
- Hypertriglyceridemia, obesity, grade2 and higher hepatosteatosis,
- Long-term drug use, alcohol intake that may damage the liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of liver stiffness levels of group 1 and group 2 patients
Time frame: 1st week, 24th week and 48th week
Liver stiffness levels of group 1 and group 2 patients were compared by measuring in kPa and m / s using 2D-SWE technique. Possible increase and decrease values in liver stiffness measurements were calculated at 24 and 48 weeks in subjects who received antiviral therapy.
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 18 Feb 2021.
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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?
An observational study of Chronic Hepatitis B and Sonoelastography, run by Seyhmus Kavak 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 3 inclusion and 8 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 18 Feb 2021. 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 liver stiffness levels of group 1 and group 2 patients (time frame: 1st week, 24th week and 48th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021.