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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00199732

Acronym

DNA-EVAL

Enrollment

Registered

2005-09-20

Start date

2004-12-31

Completion date

2009-07-31

Last updated

2013-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B, CCC DNA kinetics, Total HBV DNA kinetics, Adefovir-Dipovixil, Peg interferon alpha 2a

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.

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

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Kinetic cccDNA	6 months	Studying the kinetics of cccDNA in cells and whole blood

Countries

France

Outcome results