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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 (DNA-EVAL)

U

University of Limoges (UL)

Status

Completed

Conditions

Chronic Hepatitis B

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

19 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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