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

Recruitingn/aAges 18 Years - 80 YearsAllYaşar Bayındır, MD
NCT07459426 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Viral genetic material from blood samples using advanced sequencing technology
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Where

10 sites
Cukurova University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Adana, Turkey (Türkiye)
Gazi University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Ankara, Turkey (Türkiye)
Health Sciences University Hamidiye Faculty of Medicine
Ankara, Turkey (Türkiye)
Akdeniz University, Faculty of Medicine
Antalya, Turkey (Türkiye)
Dicle University, Faculty of Medicine
Diyarbakır, Turkey (Türkiye)
Gaziantep University
Gaziantep, Turkey (Türkiye)
Ege University, Faculty of Medicine
Izmir, Turkey (Türkiye)
Kocaeli University, Faculty of Medicine
Kocaeli, Turkey (Türkiye)

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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