Chronic Hepatitis BCHB-PATHNCT07843446
Residual Histological Disease Across Treatment Pathways in Chronic Hepatitis B
An observational study of Chronic Hepatitis B, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective, two-center observational study evaluates contemporary non-biopsy treatment pathways in treatment-naïve adults with chronic hepatitis B who underwent liver biopsy in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 1,201 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2026to 1 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic hepatitis B who underwent liver biopsy as part of routine clinical management at two tertiary-care centers in Istanbul, Türkiye. Both cohorts were biopsy-referred clinical populations and therefore do not represent unselected population-based chronic hepatitis B cohorts.
Who may be able to join
- Age ≥18 years.
- Documented hepatitis B surface antigen positivity for at least 6 months.
- No oral antiviral therapy or interferon treatment before the index liver biopsy.
- Evaluable pretreatment liver biopsy.
- Availability of sufficient clinical and laboratory data for at least one relevant analysis.
- If more than one pretreatment biopsy was available, only the first biopsy was included.
Who cannot join
- Hepatitis C virus coinfection.
- Hepatitis D virus coinfection.
- Human immunodeficiency virus coinfection.
- Hepatocellular carcinoma.
- Another chronic liver disease.
- Clinically relevant alcohol misuse.
- Previous liver transplantation.
- Inadequate histological assessment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi
Istanbul, 34722
About this study
Official title: Residual Histological Disease After Classification by Contemporary Non-Biopsy Treatment Pathways in Treatment-Naïve Chronic Hepatitis B: A Two-Center Retrospective Cohort Study
This retrospective, two-center observational study evaluates contemporary non-biopsy treatment pathways in treatment-naïve adults with chronic hepatitis B who underwent liver biopsy in routine clinical practice. The study retrospectively reconstructs the evaluable components of the WHO 2024, EASL 2025, APASL 2026, and Turkish Social Security Institution Health Implementation Communiqué (SUT) treatment pathways. The main objectives are to determine the proportion of patients classified as pathway-positive and to assess the frequency of clinically relevant histological disease among patients classified as pathway-negative. Histological disease is primarily defined as a histological activity index of at least 6 and/or Ishak fibrosis stage of at least 2. Analyses are performed overall and by study center, with additional sensitivity analyses using alternative histological definitions, a common biopsy period, and alternative alanine aminotransferase thresholds.
Read the detailed description
The study includes treatment-naïve adults with chronic hepatitis B who underwent pretreatment liver biopsy at two tertiary-care centers in Istanbul, Türkiye: Haydarpaşa Numune Training and Research Hospital and Göztepe Prof. Dr. Süleyman Yalçın City Hospital.
Clinical, virological, biochemical, hematological, and histological data were obtained retrospectively from institutional records and existing databases. Pretreatment laboratory measurements obtained within 3 months before liver biopsy are used. Histological activity is assessed using the histological activity index (HAI), and fibrosis is staged according to the Ishak system.
The primary histological outcome is significant histological disease, defined as HAI ≥6 and/or Ishak fibrosis stage ≥2.
Four contemporary non-biopsy treatment pathways are retrospectively reconstructed using the variables available in the harmonized datasets: the WHO 2024 pathway, the EASL 2025 biochemical pathway, the APASL 2026 biochemical pathway, and an exploratory Turkish SUT pathway.
These analyses do not represent complete implementation of all components of the respective guidelines because some clinical, liver-stiffness, longitudinal, fibrosis, and special-population criteria were not available in the retrospective datasets.
The principal analyses evaluate treatment-pathway positivity and the prevalence of significant histological disease among pathway-negative patients. Additional analyses assess histological disease among pathway-positive patients, individual inflammatory and fibrosis components, agreement between pathways, between-center differences, a stricter composite histological definition, fibrosis alone, restriction to the calendar period common to both centers, and alternative ALT thresholds.
- Conditions
- Chronic Hepatitis B
- Keywords
- Liver Biopsy, Liver Fibrosis, Histological Activity, Treatment Eligibility, Non-Biopsy Treatment Pathway, WHO 2024, EASL 2025, APASL, APRI, FIB-4, Turkish Social Security Institution
- Medical subject headings
- Hepatitis B, Chronic, Liver Cirrhosis
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 |
|---|---|---|
| Center A - Haydarpaşa Numune | Treatment-naïve adults with chronic hepatitis B who underwent pretreatment liver biopsy at Haydarpaşa Numune Training and Research Hospital and met the study eligibility criteria. | |
| Center B - Göztepe | Treatment-naïve adults with chronic hepatitis B who underwent pretreatment liver biopsy at Göztepe Prof. Dr. Süleyman Yalçın City Hospital and met the study eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Pathway Positivity
Proportion of evaluable participants classified as pathway-positive according to each of the four retrospectively reconstructed non-biopsy treatment pathways: WHO 2024, EASL 2025 biochemical pathway, APASL 2026 biochemical pathway, and exploratory Turkish SUT pathway.
Measured: At the index pretreatment assessment associated with liver biopsy; laboratory measurements obtained within 3 months before biopsy.
Significant Histological Disease Among Pathway-Negative Participants
Proportion of participants classified as pathway-negative who have significant histological disease, defined as histological activity index (HAI) ≥6 and/or Ishak fibrosis stage ≥2. The outcome is assessed separately for each treatment pathway and study center.
Measured: At the index pretreatment liver biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start20 Jan 2026
- Primary completion10 May 2026
- Study completion1 Sep 2026
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
- Retrospective
- Enrolment
- 1,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgür Bahadır, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843446
- Sponsor's protocol ID
- HBV-PATH-HIST-2026
- Acronym
- CHB-PATH
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Histological Disease After Classification by Contemporary Non-Biopsy Treatment Pathways in Treatment-Naïve Chronic Hepatitis B: A Two-Center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07843446
- Acronym / sponsor ID
- CHB-PATH / HBV-PATH-HIST-2026
- Conditions
- Chronic Hepatitis B
- Keywords
- Liver Biopsy, Liver Fibrosis, Histological Activity, Treatment Eligibility, Non-Biopsy Treatment Pathway, WHO 2024, EASL 2025, APASL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,201 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 28 Sep 2026 (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 retrospective, two-center observational study evaluates contemporary non-biopsy treatment pathways in treatment-naïve adults with chronic hepatitis B who underwent liver biopsy in routine clinical practice. The study retrospectively reconstructs the evaluable components of the WHO 2024, EASL 2025, APASL 2026, and Turkish Social Security Institution Health Implementation Communiqué (SUT) treatment pathways. The main objectives are to determine the proportion of patients classified as pathway-positive and to assess the frequency of clinically relevant histological disease among patients classified as pathway-negative. Histological disease is primarily defined as a histological activity index of at least 6 and/or Ishak fibrosis stage of at least 2. Analyses are performed overall and by study center, with additional sensitivity analyses using alternative histological definitions, a common biopsy period, and alternative alanine aminotransferase thresholds.
Detailed description
The study includes treatment-naïve adults with chronic hepatitis B who underwent pretreatment liver biopsy at two tertiary-care centers in Istanbul, Türkiye: Haydarpaşa Numune Training and Research Hospital and Göztepe Prof. Dr. Süleyman Yalçın City Hospital.
Clinical, virological, biochemical, hematological, and histological data were obtained retrospectively from institutional records and existing databases. Pretreatment laboratory measurements obtained within 3 months before liver biopsy are used. Histological activity is assessed using the histological activity index (HAI), and fibrosis is staged according to the Ishak system.
The primary histological outcome is significant histological disease, defined as HAI ≥6 and/or Ishak fibrosis stage ≥2.
Four contemporary non-biopsy treatment pathways are retrospectively reconstructed using the variables available in the harmonized datasets: the WHO 2024 pathway, the EASL 2025 biochemical pathway, the APASL 2026 biochemical pathway, and an exploratory Turkish SUT pathway.
These analyses do not represent complete implementation of all components of the respective guidelines because some clinical, liver-stiffness, longitudinal, fibrosis, and special-population criteria were not available in the retrospective datasets.
The principal analyses evaluate treatment-pathway positivity and the prevalence of significant histological disease among pathway-negative patients. Additional analyses assess histological disease among pathway-positive patients, individual inflammatory and fibrosis components, agreement between pathways, between-center differences, a stricter composite histological definition, fibrosis alone, restriction to the calendar period common to both centers, and alternative ALT thresholds.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Center A - Haydarpaşa Numune | – | –Treatment-naïve adults with chronic hepatitis B who underwent pretreatment liver biopsy at Haydarpaşa Numune Training and Research Hospital and met the study eligibility criteria. |
| Center B - Göztepe | – | –Treatment-naïve adults with chronic hepatitis B who underwent pretreatment liver biopsy at Göztepe Prof. Dr. Süleyman Yalçın City Hospital and met the study eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic hepatitis B who underwent liver biopsy as part of routine clinical management at two tertiary-care centers in Istanbul, Türkiye. Both cohorts were biopsy-referred clinical populations and therefore do not represent unselected population-based chronic hepatitis B cohorts.
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Documented hepatitis B surface antigen positivity for at least 6 months.
- No oral antiviral therapy or interferon treatment before the index liver biopsy.
- Evaluable pretreatment liver biopsy.
- Availability of sufficient clinical and laboratory data for at least one relevant analysis.
Key exclusion criteria (8 listed)
- Hepatitis C virus coinfection.
- Hepatitis D virus coinfection.
- Human immunodeficiency virus coinfection.
- Hepatocellular carcinoma.
- Another chronic liver disease.
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
Treatment-Pathway Positivity
Time frame: At the index pretreatment assessment associated with liver biopsy; laboratory measurements obtained within 3 months before biopsy.
Proportion of evaluable participants classified as pathway-positive according to each of the four retrospectively reconstructed non-biopsy treatment pathways: WHO 2024, EASL 2025 biochemical pathway, APASL 2026 biochemical pathway, and exploratory Turkish SUT pathway.
Significant Histological Disease Among Pathway-Negative Participants
Time frame: At the index pretreatment liver biopsy.
Proportion of participants classified as pathway-negative who have significant histological disease, defined as histological activity index (HAI) ≥6 and/or Ishak fibrosis stage ≥2. The outcome is assessed separately for each treatment pathway and study center.
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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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, run by Istanbul Medeniyet University 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 6 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 13 Oct 2026. 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?
Treatment-Pathway Positivity (time frame: At the index pretreatment assessment associated with liver biopsy; laboratory measurements obtained within 3 months before biopsy.). The study lists 2 primary outcomes in all. 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 13 Oct 2026.