Chronic Hepatitis B - Antiviral Drug Resistance - Hepatitis B Virus (HBV) InfectionPRARE-CHBNCT07274345
Prevalence and Risk Factors of Antiviral Resistance in Egyptian HBV Patients
An observational study of Chronic Hepatitis B - Antiviral Drug Resistance - Hepatitis B Virus (HBV) Infection, run by Amira Mohamed Zidan.
Trial summary
This study aims to determine the prevalence of antiviral drug resistance among Egyptian patients with chronic hepatitis B virus (HBV) infection and to identify the associated demographic, clinical, and virological risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B - Antiviral Drug Resistance - Hepatitis B Virus (HBV) Infection
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Egyptian patients diagnosed with chronic hepatitis B virus (HBV) infection and receiving antiviral therapy in routine clinical practice. Participants are recruited from outpatient hepatology and gastroenterology clinics and represent a real-life population of treated chronic HBV patients.
Who may be able to join
- This study will include all chronic HBV-infected patients, either cirrhotic or not, receiving TDF 300 mg, ETV 0.5 or 1mg, or lamivudine 100 mg, irrespective of HBeAg status. The HBV chronicity is defined by persistence of HbsAg positivity for more than 6 months.
Who cannot join
- Patients younger than 18 years old.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence and Risk Factors Associated With Resistance to Antiviral Therapy in Egyptian Patients With Chronic Hepatitis B Virus Infection
This study aims to determine the prevalence of antiviral drug resistance among Egyptian patients with chronic hepatitis B virus (HBV) infection and to identify the associated demographic, clinical, and virological risk factors. Understanding patterns of resistance will help improve treatment selection and optimize long-term management strategies for HBV patients.
- Medical subject headings
- Hepatitis B, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| This cohort includes adult Egyptian patients diagnosed with chronic hepatitis B virus (HBV) infectio | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Exhibiting Antiviral Resistance Detection of HBV Antiviral Resistance Mutations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B - Antiviral Drug Resistance - Hepatitis B Virus (HBV) InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amira Mohamed Zidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira Mohamed Zidan, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274345
- Sponsor's protocol ID
- Soh-Med--25-11-5MS
- Acronym
- PRARE-CHB
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Individual data sharing
- Undecided