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Starting soon Observational

Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)

NCT07459426 · tracked via the Priya Life Science Turkey tracker
Sponsor
Yaşar Bayındır, MD
Phase
Observational
Started
2026-03-15
Last updated
2026-03-09

Condition(s) studied

Hepatitis B, Chronic

Investigational drug(s) / intervention(s)

Viral genetic material from blood samples using advanced sequencing technology

Viral genetic material from blood samples using advanced sequencing technology: No intervention

Study summary

Chronic hepatitis B is a long-term viral infection that affects millions of people worldwide. Patients usually require lifelong antiviral treatment to control the virus and prevent liver damage.

Some older antiviral medications, such as lamivudine, can lead to the development of viral resistance. This means the virus changes in a way that makes certain treatments less effective. Even though newer drugs like entecavir are stronger and more resistant to these changes, previous exposure to lamivudine may increase the risk of developing additional resistance mutations.

By analyzing viral genetic material from blood samples using advanced sequencing technology, this research will help improve understanding of antiviral resistance patterns in patients with chronic hepatitis B in Turkey and may support better treatment decisions in the future.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Prevalence of entecavir resistance-associated mutations in the HBV polymerase/RT region detected by Oxford Nanopore sequencing. — March 15th, 2026-March 15th, 2027
    Detection of entecavir resistance-associated mutations (T184, S202, M250), with or without lamivudine resistance background mutations (L180M, M204V/I), in the HBV polymerase/RT region by Oxford Nanopore sequencing of peripheral blood-derived cccDNA. Mutations will be reported if detected at an allele frequency ≥5%.

Trial sites (1)

FacilityCityRegionStatus
Gaziantep University Gaziantep Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07459426 on ClinicalTrials.gov ↗ ← All trials in Turkey