Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV
NCT ID: NCT00313274
Last Updated: 2017-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
80 participants
INTERVENTIONAL
2003-07-31
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Clevudine
Eligibility Criteria
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Inclusion Criteria
2. Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
3. Patients who were documented to be HBsAg positive for \> 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
4. Patients who were HBeAg negative and HBeAb positive.
5. Patients with ALT levels which were in the range of ≥1.2 and \< 15 times the upper limit of normal (ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
6. Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
7. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria
2. 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.
3. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
4. Patients coinfected with HCV, HDV or HIV.
5. Patients with clinical evidence of liver mass or with alfa-fetoprotein \> 50 ng/mL
6. Patients who were pregnant or breast-feeding.
7. Patients who were unwilling to use an "effective" method of contraception during the treatment period 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)
8. Patients with a clinically relevant history of abuse of alcohol or drugs.
9. Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
10. Patients with creatinine clearance less than 60mL/min as estimated by the following formula:
(140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
18 Years
60 Years
ALL
No
Sponsors
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Bukwang Pharmaceutical
INDUSTRY
Principal Investigators
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Hyo-Suk Lee, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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St. Mercy's Hospital
Bupyoung-dong, Bupyoung-gu, Incheon, South Korea
Pusan Paik Hospital
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
Sinhŭng-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
Countries
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References
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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.
Other Identifiers
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L-FMAU-302
Identifier Type: -
Identifier Source: org_study_id
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