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Sponsored by: |
Bukwang Pharmaceutical |
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Information provided by: | Bukwang Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00313287 |
The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Drug: clevudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 Mg QD in Patients Chronically Infected With Hepatitis B Virus |
Estimated Enrollment: | 180 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | November 2004 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic GB stone, 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.
(140-age in years) (body weight [kg]) (72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
Patients who were found to have YMDD HBV DNA polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. They were to be included in the overall safety evaluation.
Principal Investigator: | Hyo-Suk Lee, MD. PhD | Seoul National University Hospital |
Study ID Numbers: | L-FMAU-301 |
Study First Received: | April 11, 2006 |
Last Updated: | April 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00313287 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
2'-fluoro-5-methylarabinosyluracil Hepatitis B Hepatitis, Viral, Human DNA Virus Infections |
Anti-Infective Agents Therapeutic Uses Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions |