Resistance to Lamivudine in HBV Egyptian Patients
This study has been completed.
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University
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
||Observational Model: Cohort
Time Perspective: Retrospective
||Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy
Biospecimen Retention: Samples With DNA
Primary Outcome Measures:
blood samples +/- tissue biopsy
| Study Start Date:
| Study Completion Date:
| 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.
Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:
- 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:
|Accepts Healthy Volunteers:
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.
- Adult patients >18 years old
- Egyptian nationality
- Positive serology for HBsAg for more than 6 months
- Positive HBV viremia (above 2000IU/ml).
- Lamivudine monotherapy
- 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 ClinicalTrials.gov identifier: NCT01548820
|Tropical medicine department
|Cairo, Egypt |
Ain Shams University
No publications provided
||Iman Fawzy Montasser, Lecturer of tropical medicine , Ain Shams university, Ain Shams University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 6, 2012
||September 8, 2013
||Egypt: Institutional Review Board
Keywords provided by Ain Shams University:
Hepatitis B virus
Resistance to treatment
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors