drugset / Trial / NCT00120796
Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)
Phase 3
Terminated
8 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
GlaxoSmithKline · collab
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Engerix-B | Vaccine | — | Intramuscular |
| Subject | Lamivudine | Other / unclassified | — | — |