Status:
COMPLETED
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Hepatitis B
Eligibility:
All Genders
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00362674
Start Date
June 1 2005
Last Update
February 1 2017
Active Locations (27)
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1
Pusan National University Hospital
Ami-dong, Seo-gu, Busan, South Korea
2
Kosin Medical Center
Amnam-dong, Seo-gu, Busan, South Korea
3
Yeungnam University Medical Center
Daemyoung-dong, Nam-gu, Daegu, South Korea
4
Keimyumg University Dongsan Medical Center
Jung-gu,, Daegu, South Korea