Status:
COMPLETED
Safety and Immunogenicity of a Naked DNA-based Vaccine Therapy in Patients With Chronic Hepatitis B
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study was to investigate whether HBV-DNA vaccination is safe and could restore immune responses in patients with chronic hepatitis B non responder to available therapies.
Detailed Description
* Despite the availability of effective hepatitis B vaccines for many years, over 370 million people remain persistently infected with hepatitis B virus (HBV). Persistent infection is associated with ...
Eligibility Criteria
Inclusion
- chronic HBV carriers
- biopsy proven chronic hepatitis
- active HBV replication for \> 6 months
- non responding to Interferon-alpha or lamivudine treatment
Exclusion
- co-infection with HIV, HCV, delta hepatitis virus
- alcohol consumption\> 40g/day
- decompensated liver disease
- HLA DR2
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00988767
Start Date
February 1 2001
End Date
October 1 2004
Last Update
September 26 2025
Active Locations (1)
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1
Service d'Hepatologie, Hopital Necker Enfants Malades
Paris, France, 75015