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Residual Histological Disease Across Treatment Pathways in Chronic Hepatitis B

Study acronym: CHB-PATH
StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Eligibility criteria expanded, about 14 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07843446
Lead Sponsor Istanbul Medeniyet University
Conditions
(from sponsor)		 Chronic Hepatitis B
Related terms Hepatitis B, Chronic, Liver Cirrhosis
Enrollment 1,201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov