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
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
|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 August 18, 2014
Hepatitis B, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action