Long-term Study With Clevudine

Phase 4

Completed

• Conditions: Chronic Hepatitis B

• Registration Number: NCT00558818
• Lead Sponsor: Bukwang Pharmaceutical

Brief Summary

A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-15
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR	Screening, day1,every 12 weeks during treatment period(96weeks)

Secondary Outcome Measures

Name	Time	Method
Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation	Screening, day1, every 12 weeks during treatment period(96 weeks)

Trial Locations

Locations (1)

KoreaUniversity Guro Hospital; 🇰🇷 Seoul, Korea, Republic of