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The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.
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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 (log10) at Week 24 | ||
| Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Patients co-infected with HCV, HDV or HIV.
Patients with clinical evidence of liver mass or with alpha-fetoprotein > 50 ng/mL
Patients who were pregnant or breast-feeding.
Patients who were unwilling to use an "effective" method of contraception during the treatment and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception ( i.e. IUD, barrier methods with spermicide or abstinence)
Patients with a clinically relevant history of abuse of alcohol or drugs.
Patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease.
The patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
Patients with creatinine clearance less than 60mL/min as estimated by the following formula :
(140-age in years) (body weight [kg]) (72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
Patients who were found to have YMDD HBV DNA polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. They were to be included in the overall safety evaluation.
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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 |
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| Proportion of 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 |
| Kyungpook National University Medical Hospital | Jung-gu | Daegu | South Korea |
| Chonnam National University Hospital | Hak-1-dong | Dong-gu, Gwangju-si | South Korea |
| Korea University Guro Hospital | Seoul | Gro-gu | South Korea |
| Wonkwang University Hospital | Iksan | Jeollabuk-do | South Korea |
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | South Korea |
| Chungnam National University Hospital | Daesadong | Jung-gu, Daechon | 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 |
| National Cancer Center | Ilsan-gu | Kyounggi-do | South Korea |
| St. Holly Family Mary's Hospital | Pucheon | 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 |
| Korea Cancer Center Hospital | Gongneungdong | Nowon-gu, Seoul | 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 |
| Gil Medical Center | Incheon | South Korea |
| Seoul National University Hospital | Seoul | 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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