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Resistance to Lamivudine in HBV Egyptian Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01548820
First received: March 6, 2012
Last updated: September 8, 2013
Last verified: September 2013
  Purpose

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients


Condition
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)
Groups/Cohorts
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.
  Eligibility

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548820

Locations
Egypt
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
ClinicalTrials.gov 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
Lamivudine
Resistance to treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases
Lamivudine
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

ClinicalTrials.gov processed this record on November 20, 2014