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

NCT00120796 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-07-21

No results posted yet for this study

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

Interventions

DRUG

Lamivudine

BIOLOGICAL

Recombinant hepatitis B surface antigen

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Papa Saliou Mbaye · Hopital Principal de Dakar Senegal

  • Muriel Vray · Institut Pasteur, Paris France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Senegal

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120796 on ClinicalTrials.gov