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

ANRS HB 05 : A Randomized, Double Blind, 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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HBe Negative Chronic Hepatitis B
• Hepatitis B Viral Infection

Interventions

Type	Name	Description
DRUG	CLEVUDINE + TENOFOVIR PLACEBO	30 MG
DRUG	CLEVUDINE IN ASSOCIATION TENOFOVIR	TENOFOVIR 300 mg qd in association with CLEVUDINE 30 mg qd
DRUG	TENOFOVIR + CLEVUDINE PLACEBO	TENOFOVIR 300 mg qd + CLEVUDINE Placebo

Timeline

• Start date: 2008-12-14
• Primary completion: 2008-12-14
• Completion: 2008-12-14
• First posted: 2009-01-15
• Last updated: 2026-04-06

Locations

1 site across 1 country: France