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Resistance to Lamivudine in HBV Egyptian Patients

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ClinicalTrials.gov Identifier: NCT01548820
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Condition or disease
Chronic Hepatitis B Virus Treatment

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 Design

Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy
Study Start Date : June 2010
Primary Completion Date : November 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lamivudine
U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548820


Locations
Egypt
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
ClinicalTrials.gov Identifier: NCT01548820     History of Changes
Other Study ID Numbers: HBV resistance
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by Iman Fawzy Montasser, Ain Shams University:
Hepatitis B virus
Lamivudine
Resistance to treatment

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