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Resistance to Lamivudine in HBV Egyptian Patients

This study is currently recruiting participants.
Verified March 2012 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01548820
First received: March 6, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  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:

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

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


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548820

Contacts
Contact: Mohammed F Montasser, Professor +01223363398 mfm1947@gmail.com

Locations
Egypt
Tropical medicine department Recruiting
Cairo, Egypt
Contact: Mohammed F Montasser, Professor     +01223363398     mfm1947@gmail.com    
Principal Investigator: Mohammed F Montasser, Professor            
Principal Investigator: Nadia AA Abd- El Kader, Assistant Professor            
Sub-Investigator: Sohair A Ismail, MD            
Sub-Investigator: Iman MF Montasser, MD            
Sub-Investigator: Diaa E Hameed, M.B.B,Ch.            
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: March 6, 2012
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 A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
 DNA Virus Infections
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on June 13, 2013