Prevalence and Risk Factors of Antiviral Resistance in Egyptian HBV Patients (PRARE-CHB)

November 27, 2025 updated by: Amira Mohamed Zidan

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients younger than 18 years old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
This cohort includes adult Egyptian patients diagnosed with chronic hepatitis B virus (HBV) infectio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Patients Exhibiting Antiviral Resistance Detection of HBV Antiviral Resistance Mutations
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amira Mohamed Zidan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med--25-11-5MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis B - Antiviral Drug Resistance - Hepatitis B Virus (HBV) Infection

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