Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
- Conditions
- Hepatitis B
- Registration Number
- NCT00362505
- Lead Sponsor
- Bukwang Pharmaceutical
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- Patient is between 18 and 60, inclusive
- Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
- Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
- Patient has 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 at week 48 in L-FMAU-301 or L-FMAU-302.
- Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
- Patients with HBV DNA < 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
- Patients with HBV DNA < 4,700 copies/mL and ALT normalization in L-FMAU-302
- Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein > 50 ng/mL
- Patient is pregnant or breast-feeding.
- Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. For males, condoms should be used. Females must 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)
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
- Patient has 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]
13.Patient whom investigator consider is not suitable in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy:change from baseline in HBV DNA; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (32)
Chungnam National University Hospital
🇰🇷Daesa-dong, Jung-gu, Daechon, Korea, Republic of
Keimyumg University Dongsan Medical Center
🇰🇷Jung-gu,, Daegu, Korea, Republic of
Kyungpook National University Medical Hospital
🇰🇷Jung-gu, Daegu, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Guro-gu, Korea, Republic of
St. Mercy's Hospital
🇰🇷Bupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Jongno-Gu, Korea, Republic of
Inha University Hospital
🇰🇷Sinhung-dong, Jung-gu, Incheon, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan-City, Jeonbuk, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju-city, Jeonbuk, Korea, Republic of
St. Holly Family Mary's Hospital
🇰🇷Puch'un, Kyounggi-do, Korea, Republic of
National Cancer Center
🇰🇷Ilsan-gu, Kyounggi-do, Korea, Republic of
Pochon CHA University Hospital
🇰🇷Seongnam-gu, Kyounggi-do, Korea, Republic of
Gil Medical Center
🇰🇷Incheon, Namdong-Gu, Korea, Republic of
Kosin Medical Center
🇰🇷Amnam-dong, Seo-gu, Pusan, Korea, Republic of
Pusan National University Hospital
🇰🇷Ami-dong, Seo-gu, Pusan, Korea, Republic of
Pusan Paik Hospital
🇰🇷Gaegeum-dong, Pusan, Korea, Republic of
Korea Cancer Center Hospital
🇰🇷Gongneung-dong, Nowon-gu, Seoul, Korea, Republic of
KangNam St. Mary's Hospital
🇰🇷Banpo-dong, Seocho-gu, Seoul, Korea, Republic of
Kangnam Sacred Heart Hospital
🇰🇷Daelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
Seoul Paik Hospital
🇰🇷Jeo-dong, Seoul, Korea, Republic of
Seoul Asan Medical Center
🇰🇷Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
Ehwa Womans University Mokdong Hospital
🇰🇷Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Pyoung-dong, Chongro-gu,, Seoul, Korea, Republic of
Severance Hospital
🇰🇷Shinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
St. Vincent's Hospital
🇰🇷Ji-dong,, Paldal-gu, Suwon, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daemyoung-dong, Nam-gu, Taegu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Hak-1-dong, Dong-gu, Gwangju-si, Korea, Republic of
St. Mary's Hospital
🇰🇷Seoul, Yungdungpo-Gu, Korea, Republic of
Korea University Anam Hospital
🇰🇷Anam-dong, Sungbuk-ku, Seoul, Korea, Republic of
Yongdong Severance Hospital
🇰🇷Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Soon Chun Hyang University Hospital
🇰🇷Hannam-dong, Yongsan-gu, Seoul, Korea, Republic of