An observational study in Chronic Hepatitis B, sponsored by Istanbul Medeniyet University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Istanbul Medeniyet University · Observational
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.
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.
942 studies on the registry are indexed under Hepatitis B, Chronic; 145 are open to participants now.
This study's enrollment of 1,201 is above the median of 400 across 226 observational studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Istanbul Medeniyet University is the lead sponsor of 188 studies on the registry; 18 are open to participants now.
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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.
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.
Exclusion Criteria:
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.
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.
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.
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.
Time frame: 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.
Time frame: At the index pretreatment liver biopsy.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Istanbul Medeniyet University