Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)

NCT00120796 | Terminated Phase 3 DMC

• 1 other identifier: ANRS 12100 HEPADAK-2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.

Conditions

Hepatitis B

Keywords

Hepatitis B; Hepatitis B Vaccines; Lamivudine

Outcome Measures

Primary Outcomes (1)

• undetectability of HBV DNA blood level

  12 months after treatment initiation (6 months after the end of the treatment)

Secondary Outcomes (7)

• HBV DNA blood levels

  3, 6, 9 and 12 months after the end of the treatment

• Transaminases blood level

  12 months

• Lamivudine treatment compliance

  12 months

• Feasibility of the vaccine injections schedule

  6 months

• Safety

  12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Lamivudine alone

Drug: Lamivudine

2

EXPERIMENTAL

Lamivudine + Vaccine

Drug: Lamivudine; Biological: Recombinant hepatitis B surface antigen

Interventions

Lamivudine DRUG

1; 2

Recombinant hepatitis B surface antigen BIOLOGICAL

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• HCV, HDV and HIV positive
• Pregnancy
• Decompensated liver cirrhosis
• Pretreated patient

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Hopital Principal

Dakar, Senegal

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Papa Saliou Mbaye

  Hopital Principal de Dakar Senegal

  PRINCIPAL INVESTIGATOR

• Muriel Vray

  Institut Pasteur, Paris France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 12, 2005
• First Posted: July 19, 2005
• Study Start: August 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: July 21, 2016

Record last verified: 2008-03

Locations

SE (1)