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Sponsored by: |
Bukwang Pharmaceutical |
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Information provided by: | Bukwang Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00362700 |
The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine
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 Retreated Clevudine in Chronic Hepatitis B Patients Who Received Clevudine in L-FMAU-201 |
Estimated Enrollment: | 33 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | October 2005 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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, Seoul | |
Ehwa Womans University Mokdong Hospital | |
Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of | |
Korea University Guro Hospital | |
80 Guro-dong, Gro-gu, Seoul, Korea, Republic of | |
Samsung Medical Center | |
Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of | |
Seoul Asan Medical Center | |
Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of | |
Seoul National University Hospital | |
28 Yeongeon-dong, Jongno-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 |
Principal Investigator: | Hyo Suk Lee, M.D., Ph.D. | Seoul National University Hospital |
Study ID Numbers: | L-FMAU-204 |
Study First Received: | August 8, 2006 |
Last Updated: | August 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00362700 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Virus Diseases Hepatitis Anti-Infective Agents Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic 2'-fluoro-5-methylarabinosyluracil Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Antiviral Agents |
Anti-Infective Agents Liver Diseases Hepatitis, Viral, Human Hepadnaviridae Infections Antiviral Agents Pharmacologic Actions Hepatitis |
Virus Diseases Digestive System Diseases Therapeutic Uses 2'-fluoro-5-methylarabinosyluracil Hepatitis B DNA Virus Infections |