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OpenTrials
Completed

NCT Number: NCT00199732

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Hépato-gastroentérologie, Limoges, France

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Kinetic cccDNA

    Time frame: 6 months

    Studying the kinetics of cccDNA in cells and whole blood

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Acronym: DNA-EVAL

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Apr 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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