Status:
TERMINATED
Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Chronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular i...
Detailed Description
Hepatitis B infection with a prevalence higher than 15% of positive Ag HBs subjects is a major public health issue in Senegal. A program of treatment of patients presenting with hepatic disease is cur...
Eligibility Criteria
Inclusion
- Written informed consent
- Liver biopsy acceptation
- B hepatitis grade over or equal to F2 Metavir score
- DNA HBV greater than 100000 copies/mL (or 10000 copies/mL if Ag Hbe negative)
- ALAT greater than 1.3 times the upper normal limit
Exclusion
- HCV, HDV and HIV positive
- Pregnancy
- Decompensated liver cirrhosis
- Pretreated patient
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00120796
Start Date
August 1 2005
End Date
July 1 2008
Last Update
July 21 2016
Active Locations (1)
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1
Hopital Principal
Dakar, Senegal