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Sponsored by: |
Bukwang Pharmaceutical |
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Information provided by: | Bukwang Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00362505 |
The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period
Condition | Intervention | Phase |
---|---|---|
Hepatitis B |
Drug: Clevudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | March 2006 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
(140-age in years) (body weight [kg])/(72)(serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
13.Patient whom investigator consider is not suitable in this study
Principal Investigator: | Hyo-Suk Lee, MD. PhD | Seoul National University Hospital |
Study ID Numbers: | L-FMAU-303 |
Study First Received: | August 8, 2006 |
Last Updated: | August 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00362505 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Virus Diseases Hepatitis Anti-Infective Agents Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic 2'-fluoro-5-methylarabinosyluracil Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Antiviral Agents |
Anti-Infective Agents Liver Diseases Hepatitis, Viral, Human Hepadnaviridae Infections Antiviral Agents Pharmacologic Actions Hepatitis |
Virus Diseases Digestive System Diseases Therapeutic Uses 2'-fluoro-5-methylarabinosyluracil Hepatitis B DNA Virus Infections |