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
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