Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial
An Open-label, Observation Study 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
1 other identifier
observational
N/A
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 8, 2006
CompletedFirst Posted
Study publicly available on registry
August 10, 2006
CompletedFebruary 1, 2017
December 1, 2010
August 8, 2006
January 30, 2017
Conditions
Eligibility Criteria
the patients who completed the previous 301, 302 and 303 studies with clevudine
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Pusan National University Hospital
Ami-dong, Seo-gu, Busan, South Korea
Kosin Medical Center
Amnam-dong, Seo-gu, Busan, South Korea
Yeungnam University Medical Center
Daemyoung-dong, Nam-gu, Daegu, South Korea
Keimyumg University Dongsan Medical Center
Jung-gu,, Daegu, South Korea
Korea University Guro Hospital
Seoul, Guro-gu, South Korea
St. Mercy's Hospital
Bupyoung-dong, Bupyoung-gu, Incheon, South Korea
Inha University Hospital
Sinhung-dong, Jung-gu, Incheon, 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
National Cancer Center
Ilsan-gu, Kyounggi-do, South Korea
St. Holly Family Mary's Hospital
Pucheon, Kyounggi-do, South Korea
Pochon CHA University Hospital
Seongnam-gu, Kyounggi-do, South Korea
Gil Medical Center
Incheon, Namdong-Gu, South Korea
Nowon Eulji Hospital
Hagyeil-tong, Nowon-gu, Seoul, South Korea
Korea University Anam Hospital
Anam-dong, Sungbuk-ku, Seoul, South Korea
Kangnam Sacred Heart Hospital
Daelim-dong, Yongdeungpo-gu, Seoul, South Korea
Yongdong Severance Hospital
Dogok-dong, Kangnam-gu, Seoul, South Korea
Korea Cancer Center Hospital
Gongneung-dong, Nowon-gu, Seoul, South Korea
Samsung Medical Center
Ilwon-dong, Songpa-gu, Seoul, South Korea
Seoul Paik Hospital
Jeo-dong, Seoul, South Korea
Ehwa Womans University Mokdong Hospital
Mok-dong, Yangcheon-gu, Seoul, South Korea
Seoul Asan Medical Center
Pungnap-dong, Kangnam-gu, Seoul, South Korea
Kangbuk Samsung Hospital
Pyoung-dong, Chongro-gu,, Seoul, South Korea
Severance Hospital
Shinchon- Dong, Seodaemun-gu, Seoul, South Korea
St. Vincent's Hospital
Ji-dong,, Paldal-gu, Suwon, South Korea
St. Mary's Hospital
Seoul, Yungdungpo-Gu, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyo-suk Lee, MD. PhD.
Seoul National University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2006
First Posted
August 10, 2006
Study Start
June 1, 2005
Last Updated
February 1, 2017
Record last verified: 2010-12