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The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: | ||
| Antiviral activity (change from baseline in HBV DNA (log 10)) | ||
| Safety: | ||
| Laboratory tests | ||
| Adverse Events | ||
| Vital signs | ||
| ECG |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | ||
| Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay) | ||
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Inclusion Criteria:
Exclusion Criteria:
(140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
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| Name | Affiliation | Role |
|---|---|---|
| Hyo-Suk Lee, MD. PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mercy's Hospital | Bupyoung-dong | Bupyoung-gu, Incheon | South Korea | |||
| Pusan Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17647293 | Derived | Yoo BC, Kim JH, Kim TH, Koh KC, Um SH, Kim YS, Lee KS, Han BH, Chon CY, Han JY, Ryu SH, Kim HC, Byun KS, Hwang SG, Kim BI, Cho M, Yoo K, Lee HJ, Hwang JS, Kim YS, Lee YS, Choi SK, Lee YJ, Yang JM, Park JW, Lee MS, Kim DG, Chung YH, Cho SH, Choi JY, Kweon YO, Lee HY, Jeong SH, Yoo HW, Lee HS. Clevudine is highly efficacious in hepatitis B e antigen-negative chronic hepatitis B with durable off-therapy viral suppression. Hepatology. 2007 Oct;46(4):1041-8. doi: 10.1002/hep.21800. |
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| Biochemical improvement (e.g. ALT normalization ) |
| Gaegeum-dong |
| Busan |
| South Korea |
| Kangbuk Samsung Hospital | Pyoung-dong | Chongro-gu, Seoul | South Korea |
| Keimyumg University Dongsan Medical Center | Jung-gu | Daegu | South Korea |
| Chonnam National University Hospital | Hak-1-dong | Dong-gu, Gwangju-si | South Korea |
| Korea University Guro Hospital | Seoul | Guro-gu | South Korea |
| Wonkwang University Hospital | Iksan | Jeollabuk-do | South Korea |
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | South Korea |
| Seoul National University Hospital | Seoul | Jongno-Gu | South Korea |
| Inha University Hospital | SinhÅng-dong | Jung-gu, Incheon | South Korea |
| Seoul Asan Medical Center | Pungnap-dong | Kangnam-gu, Seoul | South Korea |
| Yongdong Severance Hospital | Togok-tong | Kangnam-gu, Seoul | South Korea |
| St. Holly Family Mary's Hospital | Bucheonae | Kyounggi-do | South Korea |
| National Cancer Center | Ilsan-gu | Kyounggi-do | South Korea |
| Pochon CHA University Hospital | Seongnam-gu | Kyounggi-do | South Korea |
| Yeungnam University Medical Center | Dae Myoung-dong | Nam-gu, Taegu | South Korea |
| Gil Medical Center | Incheon | Namdong-Gu | South Korea |
| Nowon Eulji Hospital | Hagyeil-tong | Nowon-gu, Seoul | South Korea |
| St. Vincent's Hospital | Chi-dong | Paldal-gu, Suwon | South Korea |
| Pusan National University Hospital | Ami-dong | Seo-gu, Pusan | South Korea |
| Kosin Medical Center | Amnam-dong | Seo-gu, Pusan | South Korea |
| KangNam St. Mary's Hospital | Banpo-dong | Seocho-gu, Seoul | South Korea |
| Severance Hospital | Shinchon- Dong | Seodaemun-gu, Seoul | South Korea |
| Seoul Paik Hospital | Jeo-dong | Seoul | South Korea |
| Samsung Medical Center | Ilwon-dong | Songpa-gu, Seoul | South Korea |
| Korea University Anam Hospital | Anam-dong | Sungbuk-ku, Seoul | South Korea |
| Ehwa Womans University Mokdong Hospital | Mokdong | Yangcheon-gu, Seoul | South Korea |
| Kangnam Sacred Heart Hospital | Daelim-dong | Yongdeungpo-gu, Seoul | South Korea |
| Soon Chun Hyang University Hospital | Hannam-dong | Yongsan-gu, Seoul | South Korea |
| St. Mary's Hospital | Seoul | Yungdungpo-Gu | South Korea |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C034935 | clevudine |
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