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

NCT ID: NCT00199732

Last Updated: 2013-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-07-31

Brief Summary

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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

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\- 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

Conditions

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Chronic Hepatitis B

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Véronique Loustaud-Ratti, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Service d'Hépato-gastroentérologie

Limoges, , France

Site Status

Service de Médecine Interne

Limoges, , France

Site Status

Service de Virologie

Limoges, , France

Site Status

Service des Maladies Infectieuses et Tropicales

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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I04002

Identifier Type: -

Identifier Source: org_study_id

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