Trials / Completed
CompletedNCT00501124
Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV
Phase IV Study to Evaluate the Safety and Efficacy of Clevudine Compared With Clevudine and Vaccine in Patients Chronically Infected With HBV, HBeAg(+)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Bukwang Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Clevudine | |
| BIOLOGICAL | Purified hepatitis B surface antigen |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2010-07-01
- First posted
- 2007-07-13
- Last updated
- 2010-12-22
Locations
7 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00501124. Inclusion in this directory is not an endorsement.