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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)

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ClinicalTrials.gov Identifier: NCT00199732
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 17, 2013
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges

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
Chronic Hepatitis B

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


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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 : December 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Kinetic cccDNA [ Time Frame: 6 months ]
    Studying the kinetics of cccDNA in cells and whole blood



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis B infection and treated with adefovir dipivoxil and peg interferon alpha 2a.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199732


Locations
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France
Service d'Hépato-gastroentérologie
Limoges, France
Service de Médecine Interne
Limoges, France
Service de Virologie
Limoges, France
Service des Maladies Infectieuses et Tropicales
Limoges, France
Sponsors and Collaborators
University Hospital, Limoges
Hoffmann-La Roche
Investigators
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Principal Investigator: Véronique Loustaud-Ratti, MD University Hospital, Limoges

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00199732     History of Changes
Other Study ID Numbers: I04002
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: September 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:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Interferon-alpha
Interferon alpha-2
Adefovir
Adefovir dipivoxil
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents