Skip to main content
OpenTrials
Completed

NCT Number: NCT01548820

Resistance to Lamivudine in HBV Egyptian Patients

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis B Virus Treatment Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tropical medicine department

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Mar 8, 2012
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.