Status:
COMPLETED
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
Lead Sponsor:
University Hospital, Limoges
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
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 lymphocy...
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 inclusion...
Eligibility Criteria
Inclusion
- 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
- Co-infection HIV, HCV
Key Trial Info
Start Date :
December 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00199732
Start Date
December 1 2004
End Date
July 1 2009
Last Update
April 17 2013
Active Locations (4)
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1
Service d'Hépato-gastroentérologie
Limoges, France
2
Service de Médecine Interne
Limoges, France
3
Service de Virologie
Limoges, France
4
Service des Maladies Infectieuses et Tropicales
Limoges, France