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Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV

NCT00501124 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2010-12-22

No results posted yet for this study

Summary

A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition to monthly HBV vaccination.The purpose of this study is to investigate efficacy of combination of clevudine and HBV vaccine over clevudine alone in patients with chronic hepatitis B infection.

Conditions

Interventions

DRUG

Clevudine

BIOLOGICAL

Purified hepatitis B surface antigen

Sponsors & Collaborators

  • Bukwang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Heon Young Lee, MD. PhD. · Chungnam National University Hospital

  • Hyeon Woong Yang, MD. PhD. · Eulji University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT00501124 on ClinicalTrials.gov