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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