Clincosm LogoSign in Get a demo

DNA-EVAL: 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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT00199732
Collaborator
Hoffmann-La Roche (Industry)
19
Enrollment
4
Locations
55
Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    19 participants
    Time Perspective:
    Prospective
    Official Title:
    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
    Study Start Date :
    Dec 1, 2004
    Actual Primary Completion Date :
    Jul 1, 2009
    Actual Study Completion Date :
    Jul 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. Kinetic cccDNA [6 months]

      Studying the kinetics of cccDNA in cells and whole blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service d'Hépato-gastroentérologie Limoges France
    2 Service de Médecine Interne Limoges France
    3 Service de Virologie Limoges France
    4 Service des Maladies Infectieuses et Tropicales Limoges France

    Sponsors and Collaborators

    • University Hospital, Limoges
    • Hoffmann-La Roche

    Investigators

    • Principal Investigator: Véronique Loustaud-Ratti, MD, University Hospital, Limoges

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Limoges
    ClinicalTrials.gov Identifier:
    NCT00199732
    Other Study ID Numbers:
    • I04002
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Apr 17, 2013
    Last Verified:
    Sep 1, 2005
    Keywords provided by University Hospital, Limoges
    Chronic hepatitis B
    CCC DNA kinetics
    Total HBV DNA kinetics
    Adefovir-Dipovixil
    Peg interferon alpha 2a
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Hepatitis, Chronic

    Study Results

    No Results Posted as of Apr 17, 2013