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CompletedNCT01548820Updated Sep 10, 2013

Resistance to Lamivudine in HBV Egyptian Patients

An observational study in Chronic Hepatitis B Virus Treatment, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-09-10.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
230
Ages
18 Years to 65 Years
Sex
All
01

Study summary

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Read the 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.
02

Conditions studied

  • Chronic Hepatitis B Virus Treatment

Keywords

  • Hepatitis B virus
  • Lamivudine
  • Resistance to treatment
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 230 is below the median of 390 across 407 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • Anti-HBcIgM seropositivity
  • Positive serology for HCV
  • Positive serology for HDV
  • Patients complicated with HCC
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
230 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Chronic HBV Egyptian patients

    chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \& Tropical Medicine Research Institute in Egypt.

06

What researchers measure

Primary outcomes

  1. Resistance to Lamivudine Therapy

    Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance

    Time frame: 1 year

07

Study locations

1 site
  • Tropical medicine department
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01548820
Lead sponsor
Ain Shams University
Responsible party
Iman Fawzy Montasser (Lecturer of tropical medicine , Ain Shams university, Ain Shams University) — Principal investigator
First posted
Mar 8, 2012
Start date
Jun 2010
Primary completion
Nov 2012
Completion
Jan 2013
Last update
Sep 10, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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