NCT07843446Completed
Residual Histological Disease Across Treatment Pathways in Chronic Hepatitis B
Residual Histological Disease After Classification by Contemporary Non-Biopsy Treatment Pathways in Treatment-Naïve Chronic Hepatitis B: A Two-Center Retrospective Cohort Study
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1201 (actual)
- First submitted
- 21 Sept 2026
- Start date
- 20 Jan 2026
- Primary completion date
- 10 May 2026
- Lead sponsor
- Istanbul Medeniyet University
- Diseases
- Hepatitis B
- NCT number
- NCT07843446
What you commit to
- Study type: Observational
- Participants enrolled: 1201
- From 20 Jan 2026 to the primary completion date, 10 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous liver transplantation.
Other illness
- Hepatitis C virus coinfection.
- Hepatitis D virus coinfection.
- Another chronic liver disease.
Other
- Human immunodeficiency virus coinfection.
- Hepatocellular carcinoma.
- Clinically relevant alcohol misuse.
- Inadequate histological assessment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.