drugset / Trial / NCT00823342
ANRS HB 05 Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepatitis B, naïve to Anti-VHB Therapy
Phase 3
Terminated
150 enrolled
French National Agency for Research on AIDS and Viral Hepatitis
Gilead Sciences · collabPharmasset · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
For chronic HBV infection, an optimal pharmacological agent to promote recovery from chronic HBV infection would be one that inhibits HBV DNA polymerase, combined with the clearence from the liver of cccDNA to block HBV reactivation after the circulating viral burden has been eliminated by therapy. The activity of clevudine on cccDNA in combination with its potent antiviral activity on HBV polymerase makes it the optimal agent in combination with tenofovir for this protocol.
Timeline
- Start
- 2008-12-14
- Primary completion
- 2008-12-14
- Completion
- 2008-12-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clevudine | Small molecule | 30 mg | — |
| Comparator | Tenofovir | Small molecule | 300 mg | — |