Entecavir Resistance Mutations in chronic hepatitis B patients in Turkey

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes viral DNA from blood samples of adults with chronic hepatitis B in Turkey to map resistance mutations associated with entecavir. It compares patients who are treatment-naïve to those with prior lamivudine exposure, and uses nanopore sequencing to detect minor variants that may be missed by standard methods. The goal is to understand how resistance mutations are distributed and how they relate to prior therapies and viral load, to inform future treatment decisions. The study plans to enroll up to around 700 participants across several Turkish medical centers. Results could help tailor antiviral strategies and improve long-term management of chronic HBV infection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* HBsAg positive
* Group 1: Either treatment-naïve participants with HBV DNA\>2000 IU/ml
* Group 2: Prior lamivudine therapy ≥6 months with switch to ADVor TDF or TAF
* Ability to provide informed consent

Exclusion Criteria:

* Prior entecavir exposure
* Prior telbivudine exposure
* Age \<18 years
* Inability to provide informed consent Note: Previous adefovir or (pegylated) interferon use is not an exclusion criterion.

Patients with insufficient sample volume or inadequate DNA quality for sequencing will be excluded from final analysis.

Where it's running

• Dicle University, Faculty of Medicine
  Diyarbakır, Turkey (Türkiye) Recruiting
• Gaziantep University
  Gaziantep, Turkey (Türkiye) Recruiting
• Cukurova University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
  Adana, Turkey (Türkiye) Not yet recruiting
• Gazi University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
  Ankara, Turkey (Türkiye) Not yet recruiting
• Health Sciences University Hamidiye Faculty of Medicine
  Ankara, Turkey (Türkiye) Not yet recruiting
• Akdeniz University, Faculty of Medicine
  Antalya, Turkey (Türkiye) Not yet recruiting

Study contacts

• Study coordinator: Yaşar Bayındır, MD, Prof.
• Email: yasar.bayindir@guven.com.tr
• Phone: +905323659909

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.