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 - Full Text View

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)

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University Hospital, Limoges Laboratoire Roche
Information provided by:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00199732

Purpose

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
Chronic Hepatitis B

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Peginterferon Alfa-2a Hepatitis B Vaccines Interferon alfa-n1 Interferon alfa-2a Interferons Adefovir dipivoxil Adefovir

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

Further study details as provided by University Hospital, Limoges:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	25
Study Start Date:	December 2004
Estimated Study Completion Date:	July 2009

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199732

Locations

France
Service de Médecine Interne
Limoges, France
Service d'Hépato-gastroentérologie
Limoges, France
Service des Maladies Infectieuses et Tropicales
Limoges, France
Service de Virologie
Limoges, France

Sponsors and Collaborators

University Hospital, Limoges

Laboratoire Roche

Investigators

Principal Investigator:

Véronique Loustaud-Ratti, MD

University Hospital, Limoges

More Information

Study ID Numbers:	I04002
Study First Received:	September 14, 2005
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00199732
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Limoges:

Chronic hepatitis B
CCC DNA kinetics
Total HBV DNA kinetics
Adefovir-Dipovixil
Peg interferon alpha 2a

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Interferons
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases

Hepatitis B, Chronic
Hepatitis B
Peginterferon alfa-2a
Adefovir dipivoxil
DNA Virus Infections
Interferon Alfa-2a
Adefovir

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Hepadnaviridae Infections
Antiviral Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009