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Sponsored by: |
Bukwang Pharmaceutical |
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Information provided by: | Bukwang Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00313261 |
The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Drug: Clevudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of L-FMAU (Clevudine) in Chronic Hepatitis B Patients of L-FMAU-201 Placebo Group |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | February 2005 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1)had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a >= 1 log10 decrease from baseline in HBV DNA at Week 48
Exclusion Criteria:
(140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
Korea, Republic of, Guro-ku, Seoul | |
Korea University Guro Hospital | |
Guro-dong, Guro-ku, Seoul, Korea, Republic of | |
Korea, Republic of, Jongno-Gu, Seoul | |
Seoul National University | |
Yeongeon-dong, Jongno-Gu, Seoul, Korea, Republic of | |
Korea, Republic of, Kangnam-Gu, Seoul | |
Samsung Medical Center | |
Ilwon-dong, Kangnam-Gu, Seoul, Korea, Republic of | |
Yongdong Severance Hospital | |
Dogok-dong, Kangnam-Gu, Seoul, Korea, Republic of | |
Korea, Republic of, Songpa-Gu, Seoul | |
Asan Medical Center | |
Pungnab2-dong, Songpa-Gu, Seoul, Korea, Republic of | |
Korea, Republic of, Yangchon-Gu, Seoul | |
Ewha Womans University Hospital | |
Mok-dong, Yangchon-Gu, Seoul, Korea, Republic of | |
Korea, Republic of, Yougdungpo-Gu, Seoul | |
St. Mary’s Hospital | |
Youido, Yougdungpo-Gu, Seoul, Korea, Republic of |
Principal Investigator: | Hyo Suk Lee, M.D., Ph.D. | Seoul National University Hospital |
Study ID Numbers: | L-FMAU-203 |
Study First Received: | April 11, 2006 |
Last Updated: | April 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00313261 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic 2'-fluoro-5-methylarabinosyluracil Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
Anti-Infective Agents Therapeutic Uses Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions |