Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a

Overview

Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver. Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment. The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2009

Detailed Description

– Studying intra lymphocyte and blood cccDNA: before inclusions, D0 then each month during the first three months each three months during treatment and follow-up. – Viral kinetics:Before inclusions, at D0, then monthly till the end of treatment and follow-up: Evolution of quantitative viraemia in serum Evolution of quantitative viraemia in circulating lymphocytes Evolution of quantitative viraemia in total blood – Studying viral genotypes

Clinical Trial Outcome Measures

Primary Measures

  • Kinetic cccDNA
    • Time Frame: 6 months
    • Studying the kinetics of cccDNA in cells and whole blood

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female patients >18 years of age and <70 years of age – Patients AgHbs+ and AgHbe+ or AgHbe-, and B viral DNA >104 copies/ml PCR COBAS MONITOR – Patients treated with adefovir dipivoxil and peg interferon alpha 2a – Chronic liver disease consistent with chronic hepatitis B infection on a biopsy obtained within the past 24 months – Naïve patients or patients having a relapse or a therapeutic failure after monotherapy lamivudine or interferon, or bitherapy interferon alpha-lamivudine Exclusion Criteria:

  • Co-infection HIV, HCV

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Limoges
  • Collaborator
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Véronique Loustaud-Ratti, MD, Principal Investigator, University Hospital, Limoges

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