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

Completed

• Conditions: Chronic Hepatitis B

• Registration Number: NCT00199732
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2004-12
• Status Verified: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Last Update Submitted: 2013-04-16
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kinetic cccDNA	6 months	Studying the kinetics of cccDNA in cells and whole blood

Trial Locations

Locations (4)

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