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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
  Contacts and Locations
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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

No publications provided

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
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on November 27, 2015