Tracking entecavir resistance in the hepatitis B virus of adults in Turkey
Studies viral gene changes in blood of adults with chronic hepatitis B.
Key facts
- Who runs it
- Yaşar Bayındır, MD
- Where
- Adana, Ankara, Antalya, Diyarbakır, Gaziantep, Izmir, Kocaeli, Malatya, and Samsun, TürkiyeSee the 10 sites
- Trial code
- Registry title
- Entecavir Resistance-Associated Mutations in Chronic HBV Patients in Turkey (STREAM Study)
- Status
- Recruiting
- People taking part
- 700 people, planned
- Started
- 15 Mar 2026
- Expected to end
- 15 Sept 2027
- Type of study
- Observational, 2 groups
- Treatments tested
- Viral genetic material from blood samples using advanced sequencing technology
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis B, either never treated with HBV DNA above 2000 IU/ml, or treated with lamivudine for at least 6 months and then switched. Blood samples are checked for resistance changes in the virus.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Chronic hepatitis B with a positive HBsAg test.
- Earlier treatment
- Group 1: never treated, with HBV DNA above 2000 IU/ml. Group 2: lamivudine for at least 6 months, then switched to ADV or TDF or TAF. Earlier adefovir or (pegylated) interferon use does not stop anyone from joining.
- Biomarker or test result
- HBsAg positive. Group 1 needs HBV DNA above 2000 IU/ml.
Main reasons for not taking part
- Earlier entecavir treatment
- Earlier telbivudine treatment
- Younger than 18 years
- Cannot give informed consent
- Blood sample too small or DNA quality too poor for sequencing
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior entecavir exposure
- Prior telbivudine exposure
- 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
- Age <18 years
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Türkiye
- Cukurova University, Faculty of Medicine, Department of Infectious Diseases and Clinical MicrobiologyAdana, TürkiyeContact: Yesim Tasova, MD, Prof.Not yet recruiting
- Gazi University, Faculty of Medicine, Department of Infectious Diseases and Clinical MicrobiologyAnkara, TürkiyeContact: Yesim Yildiz, MD, Assoc. Prof.Not yet recruiting
- Health Sciences University Hamidiye Faculty of MedicineAnkara, TürkiyeContact: Funda Simsek, MD, Prof.Not yet recruiting
- Akdeniz University Faculty of MedicineAntalya, TürkiyeContact: Dilara Inan, MD, Prof.Not yet recruiting
- Dicle University Faculty of MedicineDiyarbakır, TürkiyeContact: Mustafa Kemal Celen, MD, Prof.Taking people
- Gaziantep UniversityGaziantep, TürkiyeContact: Ayse Ozlem Mete, MDTaking people
- Ege University Faculty of MedicineIzmir, TürkiyeContact: Tansu Yamazhan, MD, Prof.Not yet recruiting
- Kocaeli University Faculty of MedicineKocaeli, TürkiyeContact: Sila Akhan, MD, Prof.Not yet recruiting
- İnönü University, Faculty of Medicine, Department of Clinical MicrobiologyMalatya, TürkiyeContact: Baris Otlu, PhD, Prof.Not yet recruiting
- Samsun Ondokuz Mayıs University, Faculty of Medicine, Department of Infectious Diseases and Clinical MicrobiologySamsun, TürkiyeContact: Ozgur Gunal, MD, Prof.Not yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Treatment-Naïve Chronic HBV Patients
Adult (≥18 years) HBsAg-positive patients with HBV-DNA \>2,000 IU/mL who have not received prior nucleos(t)ide analogue therapy.
Treatment: Viral genetic material from blood samples using advanced sequencing technology
- Lamivudine-Experienced Chronic HBV Patients
Adult (≥18 years) HBsAg-positive patients with a documented history of lamivudine therapy for ≥6 months who were subsequently switched to tenofovir-based therapy (ADV, TDF, or TAF) and have not received entecavir or telbivudine.
Treatment: Viral genetic material from blood samples using advanced sequencing technology
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Sequencing-Based Tracking of Entecavir Resistance-Associated Mutations in Chronic Hepatitis B Patients: A Multicenter Observational Study (STREAM)
- Plain-language title
- Tracking entecavir resistance in the hepatitis B virus of adults in TurkeyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07459426, who can take part
- Record updated
- 13 October 2026