Resistance to Lamivudine in HBV Egyptian Patients

NCT ID: NCT01548820

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-01-31

Brief Summary

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On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Detailed Description

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Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:

* ALT.
* HBeAg.
* HBV-DNA by quantitative PCR.
* Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.

Conditions

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Chronic Hepatitis B Virus Treatment

Keywords

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Hepatitis B virus Lamivudine Resistance to treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chronic HBV Egyptian patients

chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \& Tropical Medicine Research Institute in Egypt.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients \>18 years old
* Egyptian nationality
* Positive serology for HBsAg for more than 6 months
* Positive HBV viremia (above 2000IU/ml).
* Lamivudine monotherapy

Exclusion Criteria

* Anti-HBcIgM seropositivity
* Positive serology for HCV
* Positive serology for HDV
* Patients complicated with HCC
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Iman Fawzy Montasser

Lecturer of tropical medicine , Ain Shams university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tropical medicine department

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HBV resistance

Identifier Type: -

Identifier Source: org_study_id