drugset / Trial / NCT00120796

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

NCT00120796 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Outcome not reported

Stopped: “poor patient recrutment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Engerix-B Vaccine — Intramuscular
Subject Lamivudine Other / unclassified — —