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Resistance to Lamivudine in HBV Egyptian Patients

This study has been completed.
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University Identifier:
First received: March 6, 2012
Last updated: September 8, 2013
Last verified: September 2013
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Chronic Hepatitis B Virus Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy

Resource links provided by NLM:

Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • 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

Biospecimen Retention:   Samples With DNA
blood samples +/- tissue biopsy

Enrollment: 230
Study Start Date: June 2010
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Chronic HBV Egyptian patients
chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology & Tropical Medicine Research Institute in Egypt.

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
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Please refer to this study by its identifier: NCT01548820

Tropical medicine department
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
  More Information

Responsible Party: Iman Fawzy Montasser, Lecturer of tropical medicine , Ain Shams university, Ain Shams University Identifier: NCT01548820     History of Changes
Other Study ID Numbers: HBV resistance
Study First Received: March 6, 2012
Last Updated: September 8, 2013

Keywords provided by Ain Shams University:
Hepatitis B virus
Resistance to treatment

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents processed this record on May 23, 2017