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Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial | Clinical Trials | Clareo Health

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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

NCT00362674•Bukwang Pharmaceutical

View on ClinicalTrials.gov

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

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303.
•2. 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.
•3. 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
•4. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
•5. 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 Criteria

•1. Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302.
•2. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
•3. Patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
•4. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
•5. Patients co-infected with HCV, HDV or HIV.
•6. 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.
•7. Patients who were pregnant or breast-feeding.
•8. 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.
•9. Patients who were not suitable to the study if judged by an investigator.

Locations (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

Key Dates

Start Date

June 1, 2005

Last Updated

February 1, 2017

Conditions

Hepatitis B

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial

Inclusion Criteria

Exclusion Criteria

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