Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201
- Conditions
- Hepatitis B
- Registration Number
- NCT00362700
- Lead Sponsor
- Bukwang Pharmaceutical
- Brief Summary
The purpose of this study is to determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
- Patients who received clevudine in L-FMAU-201 clinical trial (phase IIb)
- Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test within 14 days of starting therapy.
- Patient is able to give written informed consent prior to study start and to comply with the study requirements.
- Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60: 1) had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a > 1 log10 decrease from baseline in HBV DNA at Week 48
- HBV DNA negative (< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval)
- Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient is coinfected with HCV, HDV or HIV.
- Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein) Evaluation will be based on alpha-fetoprotein primarily. If alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc.
- 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), post-menopausal or using at least a 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, neurological, cardiovascular, oncologic or allergic disease.
- 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]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Antiviral activity- Change from baseline in HBV DNA (log10) Safety- Laboratory tests, Adverse Events, Vital Signs, ECG
- Secondary Outcome Measures
Name Time Method Antiviral activity- Proportion of patients with HBV DNA below the assay Limit of Detection(<4,700 copies/mL by Digene Hybrid Capture II) Biochemical improvement (ALT normalization) Serology: Proportion of patients with HBeAg loss,Seroconversion rate (HBeAg loss and anti-HBe gain)
Trial Locations
- Locations (7)
Yongdong Severance Hospital
🇰🇷Dogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Ilwon-dong, Songpa-gu, Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Pungnab2-dong, Songpa-Gu, Seoul, Korea, Republic of
Ehwa Womans University Mokdong Hospital
🇰🇷Mok-dong, Yangcheon-gu, Seoul, Korea, Republic of
Seoul Asan Medical Center
🇰🇷Pungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Guro-gu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Jongno-Gu, Korea, Republic of