Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV
- Conditions
- Hepatitis B
- Registration Number
- NCT00313274
- Lead Sponsor
- Bukwang Pharmaceutical
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
- Patients who were between 18 and 60, inclusive
- Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
- 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).
- Patients who were HBeAg negative and HBeAb positive.
- 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.
- Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
- Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
- 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 coinfected with HCV, HDV or HIV.
- Patients with clinical evidence of liver mass or with alfa-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 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)
- Patients with a clinically relevant history of abuse of alcohol or drugs.
- 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.
- 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]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety: Laboratory tests ECG Efficacy: Antiviral activity (change from baseline in HBV DNA (log 10)) Adverse Events Vital signs
- Secondary Outcome Measures
Name Time Method 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) Biochemical improvement (e.g. ALT normalization )
Trial Locations
- Locations (30)
St. Mary's Hospital
🇰🇷Seoul, Yungdungpo-Gu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Dae myoung-dong, Nam-gu, Taegu, Korea, Republic of
St. Mercy's Hospital
🇰🇷Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul City, Guro-gu, Korea, Republic of
Nowon Eulji Hospital
🇰🇷Hagye 1-dong, Nowon-gu, Seoul, Korea, Republic of
Keimyumg University Dongsan Medical Center
🇰🇷Jung-gu, Daegu, Korea, Republic of
Pochon CHA University Hospital
🇰🇷Seongnam-gu, Kyounggi-do, Korea, Republic of
Gil Medical Center
🇰🇷Incheon, Namdong-Gu, Korea, Republic of
Seoul Paik Hospital
🇰🇷Jeo-dong, Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Pyoung-dong, Chongro-gu, Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Hak-1-dong, Dong-gu, Gwangju-si, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan-City, Jeonbuk, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju-city, Jeonbuk, Korea, Republic of
Inha University Hospital
🇰🇷Sinhung-dong, Jung-gu, Incheon, Korea, Republic of
Yongdong Severance Hospital
🇰🇷Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Seoul Asan Medical Center
🇰🇷Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
National Cancer Center
🇰🇷Ilsan-gu, Kyounggi-do, Korea, Republic of
St. Holly Family Mary's Hospital
🇰🇷Puch'onae, Kyounggi-do, Korea, Republic of
Pusan Paik Hospital
🇰🇷Gaegeum-dong, Pusan, Korea, Republic of
St. Vincent's Hospital
🇰🇷Ji-dong, Paldal-gu, Suwon, Korea, Republic of
Severance Hospital
🇰🇷Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
Kosin Medical Center
🇰🇷Amnam-dong, Seo-gu, Pusan, Korea, Republic of
KangNam St. Mary's Hospital
🇰🇷Banpo-dong, Seocho-gu, Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Ami-dong, Seo-gu, Pusan, Korea, Republic of
Korea University Anam Hospital
🇰🇷Anam-dong, Sungbuk-ku, Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
Ehwa Womans University Mokdong Hospital
🇰🇷Mokdong, Yangcheon-gu, Seoul, Korea, Republic of
Kangnam Sacred Heart Hospital
🇰🇷Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
Soon Chun Hyang University Hospital
🇰🇷Hannam-dong, Yongsan-gu, Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Jongno-Gu, Korea, Republic of