Trial record 1 of 1 for:    NCT01548820
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Resistance to Lamivudine in HBV Egyptian Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iman Fawzy Montasser, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01548820
First received: March 6, 2012
Last updated: September 8, 2013
Last verified: September 2013

March 6, 2012
September 8, 2013
June 2010
November 2012   (final data collection date for primary outcome measure)
Resistance to Lamivudine Therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance
Same as current
Complete list of historical versions of study NCT01548820 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Resistance to Lamivudine in HBV Egyptian Patients
Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

blood samples +/- tissue biopsy

Non-Probability Sample

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.

Chronic Hepatitis B Virus Treatment
Not Provided
Chronic HBV Egyptian patients
chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology & Tropical Medicine Research Institute in Egypt.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
January 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01548820
HBV resistance
Yes
Iman Fawzy Montasser, Ain Shams University
Ain Shams University
Not Provided
Not Provided
Ain Shams University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP