Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial
- Conditions
- Hepatitis B
- Registration Number
- NCT00362674
- Lead Sponsor
- Bukwang Pharmaceutical
- Brief Summary
The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303.
- Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL in L-FMAU-301 or L-FMAU-302, in addition, HBeAg seroconverted to anti-HBe at the last two visits in L-FMAU-301) after completion of L-FMAU-301 or L-FMAU-302 and treated with the clevudine.
- Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL, in addition HBeAg seroconverted to anti-HBe at the last two visits who showed HBeAg positiv at baseline) after completion of L-FMAU-303
- Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
- Patients with bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL at the last visit in L-FMAU-301, L-FMAU-302 or L-FMAU-303.
- Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302.
- Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
- Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patients co-infected with HCV, HDV or HIV.
- Patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic GB stone during the L-FMAU-301, L-FMAU-302 or L-FMAU-303.
- Patients who were pregnant or breast-feeding.
- Patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic GB stone, bronchopulmonary, 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 who were not suitable to the study if judged by an investigator.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Korea University Guro Hospital
๐ฐ๐ทSeoul, Guro-gu, Korea, Republic of
Keimyumg University Dongsan Medical Center
๐ฐ๐ทJung-gu,, Daegu, Korea, Republic of
St. Holly Family Mary's Hospital
๐ฐ๐ทPucheon, Kyounggi-do, Korea, Republic of
Gil Medical Center
๐ฐ๐ทIncheon, Namdong-Gu, Korea, Republic of
St. Mercy's Hospital
๐ฐ๐ทBupyoung-dong, Bupyoung-gu, Incheon, Korea, Republic of
Chonbuk National University Hospital
๐ฐ๐ทJeonju-city, Jeonbuk, Korea, Republic of
Wonkwang University Hospital
๐ฐ๐ทIksan-City, Jeonbuk, Korea, Republic of
Kangnam Sacred Heart Hospital
๐ฐ๐ทDaelim-dong, Yongdeungpo-gu, Seoul, Korea, Republic of
Seoul National University Hospital
๐ฐ๐ทSeoul, Jongno-Gu, Korea, Republic of
National Cancer Center
๐ฐ๐ทIlsan-gu, Kyounggi-do, Korea, Republic of
Pochon CHA University Hospital
๐ฐ๐ทSeongnam-gu, Kyounggi-do, Korea, Republic of
Nowon Eulji Hospital
๐ฐ๐ทHagye 1-dong, Nowon-gu, Seoul, Korea, Republic of
Seoul Paik Hospital
๐ฐ๐ทJeo-dong, Seoul, Korea, Republic of
Ehwa Womans University Mokdong Hospital
๐ฐ๐ทMok-dong, Yangcheon-gu, Seoul, Korea, Republic of
Korea Cancer Center Hospital
๐ฐ๐ทGongneung-dong, Nowon-gu, Seoul, Korea, Republic of
Samsung Medical Center
๐ฐ๐ทIlwon-dong, Songpa-gu, Seoul, Korea, Republic of
Seoul Asan Medical Center
๐ฐ๐ทPungnap-dong, Kangnam-gu, Seoul, Korea, Republic of
Kangbuk Samsung Hospital
๐ฐ๐ทPyoung-dong, Chongro-gu,, Seoul, Korea, Republic of
Severance Hospital
๐ฐ๐ทShinchon- dong, Seodaemun-gu, Seoul, Korea, Republic of
St. Vincent's Hospital
๐ฐ๐ทJi-dong,, Paldal-gu, Suwon, Korea, Republic of
St. Mary's Hospital
๐ฐ๐ทSeoul, Yungdungpo-Gu, Korea, Republic of
Inha University Hospital
๐ฐ๐ทSinhung-dong, Jung-gu, Incheon, Korea, Republic of
Pusan National University Hospital
๐ฐ๐ทAmi-dong, Seo-gu, Pusan, Korea, Republic of
Kosin Medical Center
๐ฐ๐ทAmnam-dong, Seo-gu, Pusan, Korea, Republic of
Korea University Anam Hospital
๐ฐ๐ทAnam-dong, Sungbuk-ku, Seoul, Korea, Republic of
Yongdong Severance Hospital
๐ฐ๐ทDogok-dong, Kangnam-gu, Seoul, Korea, Republic of
Yeungnam University Medical Center
๐ฐ๐ทDaemyoung-dong, Nam-gu, Taegu, Korea, Republic of