Resistance to Lamivudine in HBV Egyptian Patients

September 8, 2013 updated by: Iman Fawzy Montasser, Ain Shams University

Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Tropical medicine department

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology & Tropical Medicine Research Institute in Egypt in the period from 2007- 2011.

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Chronic HBV Egyptian patients
chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology & Tropical Medicine Research Institute in Egypt.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistance to Lamivudine Therapy
Time Frame: 1 year
Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance
1 year

Collaborators and Investigators

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

Sponsor

Ain Shams University

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

June 1, 2010

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

March 6, 2012

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 8, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV resistance

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.

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