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

Chronic Hepatitis B Clinical Trial

— DNA-EVAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199732
• Other study ID #: I04002
• Status: Completed
• Phase: N/A
• First received: September 14, 2005
• Last updated: April 16, 2013
• Start date: December 2004
• Est. completion date: July 2009

Study information

• Verified date: September 2005
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetic cccDNA	Studying the kinetics of cccDNA in cells and whole blood	6 months	No