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The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:change from baseline in HBV DNA; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:; Proportion of patients with HBV DNA below the assay Limit of Detection; Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain); Proportion of ALT normalization |
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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]
13.Patient whom investigator consider is not suitable in this study
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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 |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Ami-dong, Seo-gu | Busan | South Korea | |||
| Kosin Medical Center |
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| Amnam-dong, Seo-gu |
| Busan |
| South Korea |
| Pusan Paik Hospital | Gaegeum-dong | Busan | South Korea |
| Chungnam National University Hospital | Daesa-dong, Jung-gu | Daechon | South Korea |
| Yeungnam University Medical Center | Daemyoung-dong, Nam-gu | Daegu | South Korea |
| Keimyumg University Dongsan Medical Center | Jung-gu, | Daegu | South Korea |
| Kyungpook National University Medical Hospital | Jung-gu | Daegu | South Korea |
| Korea University Guro Hospital | Seoul | Guro-gu | South Korea |
| Chonnam National University Hospital | Hak-1-dong, Dong-gu | Gwangju | South Korea |
| St. Mercy's Hospital | Bupyoung-dong, Bupyoung-gu | Incheon | South Korea |
| Inha University Hospital | Sinhung-dong, Jung-gu | Incheon | 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 |
| National Cancer Center | Ilsan-gu | Kyounggi-do | South Korea |
| St. Holly Family Mary's Hospital | Puch’un | Kyounggi-do | South Korea |
| Pochon CHA University Hospital | Seongnam-gu | Kyounggi-do | South Korea |
| Gil Medical Center | Incheon | Namdong-Gu | South Korea |
| Korea University Anam Hospital | Anam-dong, Sungbuk-ku | Seoul | South Korea |
| KangNam St. Mary's Hospital | Banpo-dong, Seocho-gu | Seoul | South Korea |
| Kangnam Sacred Heart Hospital | Daelim-dong, Yongdeungpo-gu | Seoul | South Korea |
| Yongdong Severance Hospital | Dogok-dong, Kangnam-gu | Seoul | South Korea |
| Korea Cancer Center Hospital | Gongneung-dong, Nowon-gu | Seoul | South Korea |
| Soon Chun Hyang University Hospital | Hannam-dong, Yongsan-gu | Seoul | South Korea |
| Samsung Medical Center | Ilwon-dong, Songpa-gu | Seoul | South Korea |
| Seoul Paik Hospital | Jeo-dong | Seoul | South Korea |
| Ehwa Womans University Mokdong Hospital | Mok-dong, Yangcheon-gu | Seoul | South Korea |
| Seoul Asan Medical Center | Pungnap-dong, Kangnam-gu | Seoul | South Korea |
| Kangbuk Samsung Hospital | Pyoung-dong, Chongro-gu, | Seoul | South Korea |
| Severance Hospital | Shinchon- Dong, Seodaemun-gu | Seoul | South Korea |
| St. Vincent's Hospital | Ji-dong,, Paldal-gu | Suwon | 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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