Resistance to Lamivudine in HBV Egyptian Patients

Chronic Hepatitis B Virus Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548820
• Other study ID #: HBV resistance
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: September 8, 2013
• Start date: June 2010
• Est. completion date: January 2013

Study information

• Verified date: September 2013
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Hepatitis B Virus Treatment
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Egypt	Tropical medicine department	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resistance to Lamivudine Therapy	Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance	1 year	No