Prevalence and Risk Factors of Antiviral Resistance in Eg... | NCT07274345

Studies
Prevalence and Risk Factors of Antiviral Resistance in Egyptian HBV Patients

NCT07274345

Sponsor

Amira Mohamed Zidan

Status

Not yet recruiting

Last Update Posted

Dec 10, 2025Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Nov 27, 2025

First Submission Date that Met QC Criteria

Nov 27, 2025

First Posted Date

Dec 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2025

Last Update Posted Date

Dec 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amira Mohamed Zidan, Resident Doctor Tropical Medicine and Gastroenterology, Sohag UniversitySponsor-Investigator

Lead Sponsor

Amira Mohamed ZidanOTHER

Collaborators

Not provided

Description Module

Brief 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. Understanding patterns of resistance will help improve treatment selection and optimize long-term management strategies for HBV patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Label	Type	Description	Intervention Names
This cohort includes adult Egyptian patients diagnosed with chronic hepatitis B virus (HBV) infectio

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amira Mohamed Zidan	Contact	201122884060		amira_mohamed_post@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B
D007239	Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided