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| Sponsor: | Bukwang Pharmaceutical |
|---|---|
| Information provided by: | Bukwang Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00501124 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B |
Drug: Clevudine Biological: Purified hepatitis B surface antigen |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase IV Study to Evaluate the Safety and Efficacy of Clevudine Compared With Clevudine and Vaccine in Patients Chronically Infected With HBV, HBeAg(+) |
| Estimated Enrollment: | 70 |
| Study Start Date: | May 2007 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Korea, Republic of | |
| Chungbuk National University Hospital | |
| Gaesin-dong, Cheongju Si Heungdeok-gu, Chungcheongbuk-Do, Korea, Republic of | |
| Dankook University Hospital | |
| Anseo-dong, Cheonan Si, Chungcheongnam-Do, Korea, Republic of | |
| Soon Chun Hyang University Cheonan Hospital | |
| Bongmyeong-dong, Cheonan Si, Chungcheongnam-Do, Korea, Republic of | |
| The Catholic University of Korea, Daejeon St. Mary's Hospital | |
| Daeheung-dong, Jung-gu, Daejeon, Korea, Republic of | |
| Chungnam National University Hospital | |
| Daesa-dong, Jung-gu, Daejeon, Korea, Republic of | |
| Eulji University Hospital | |
| Dunsan 2-dong, Seo-gu, Daejeon, Korea, Republic of | |
| Konyang University Hospital | |
| Gasuwon-dong, Seo-gu,, Daejeon, Korea, Republic of | |
| Principal Investigator: | Heon Young Lee, MD. PhD. | Chungnam National University Hospital |
| Principal Investigator: | Hyeon Woong Yang, MD. PhD. | Eulji University Hospital |
More Information
| Responsible Party: | HY Lee, Chungnam University Hospital |
| ClinicalTrials.gov Identifier: | NCT00501124 History of Changes |
| Other Study ID Numbers: | L-FMAU-402 |
| Study First Received: | July 12, 2007 |
| Last Updated: | December 21, 2010 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections 2'-fluoro-5-methylarabinosyluracil Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |