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Sponsored by: |
Bukwang Pharmaceutical |
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Information provided by: | Bukwang Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00362635 |
The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
Condition | Intervention | Phase |
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Hepatitis B |
Drug: Clevudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blinded and Randomised Study to Compare the Efficacy and Safety of 48-Week Treatment With Clevudine 30 mg qd Versus Lamivudine 100 mg qd for Chronic Hepatitis B Infection |
Estimated Enrollment: | 92 |
Study Start Date: | August 2006 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hong Kong, New Territories | |
Alice Ho Miu Ling Nethersole Hospital | |
11 Chuen On Road Tai po, New Territories, Hong Kong | |
Hong Kong, Special Administrative Region | |
Queen Mary Hospital | |
102 Pokfulam Road, Special Administrative Region, Hong Kong |
Principal Investigator: | George KK Lau, M.D. | Queen Mary Hospital; |
Principal Investigator: | Nancy Leung, M.D. | Alice Ho Miu Ling Nethersole Hospital |
Study ID Numbers: | CLV-310 |
Study First Received: | August 8, 2006 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00362635 History of Changes |
Health Authority: | Hong Kong: Department of Health |
Anti-Infective Agents Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Lamivudine Antiviral Agents Hepatitis |
Virus Diseases Digestive System Diseases Hepatitis B, Chronic 2'-fluoro-5-methylarabinosyluracil Hepatitis B DNA Virus Infections |
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 |