Resistance to Lamivudine in HBV Egyptian Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01548820

Enrollment

230

Registered

2012-03-08

Start date

2010-06-30

Completion date

2013-01-31

Last updated

2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B Virus Treatment

Keywords

Hepatitis B virus, Lamivudine, Resistance to treatment

Brief summary

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Resistance to Lamivudine Therapy	1 year	Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance

Countries

Egypt

Outcome results