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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

NCT00823342 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Pharmasset

    collaborator INDUSTRY

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • MARC BOURLIERE, MD · Hôpital Saint Joseph, marseille, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-14
Primary Completion
2008-12-14
Completion
2008-12-14

Countries

  • France

Study Locations

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Entities

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 NCT00823342 on ClinicalTrials.gov