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Sponsored by: |
Bukwang Pharmaceutical |
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Information provided by: | Bukwang Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00641082 |
A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.
Condition | Intervention | Phase |
---|---|---|
HBeAg(-) Chronic Hepatitis B With Compensated Liver Function |
Drug: Clevudine Drug: Adefovir dipivoxil |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-Week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function |
Estimated Enrollment: | 72 |
Study Start Date: | February 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Clevudine
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Drug: Clevudine
30mg for 48 weeks
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2: Active Comparator
Adefovir
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Drug: Adefovir dipivoxil
10mg for 48 weeks
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Patient with following clinical evidence
Contact: Hyo -Suk Lee, MD. PhD | 82-2-828-8082 | semoon@bukwang.co.kr |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of |
Study ID Numbers: | CLV-401 |
Study First Received: | March 5, 2008 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00641082 History of Changes |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Liver Diseases Hepatitis, Chronic Hepatitis, Viral, Human Antiviral Agents Reverse Transcriptase Inhibitors Hepatitis Virus Diseases Digestive System Diseases |
Anti-Retroviral Agents Hepatitis B, Chronic 2'-fluoro-5-methylarabinosyluracil Hepatitis B DNA Virus Infections Adefovir dipivoxil Adefovir |
Anti-Infective Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Hepatitis, Viral, Human Enzyme Inhibitors Hepadnaviridae Infections Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Hepatitis |
Virus Diseases Digestive System Diseases Anti-Retroviral Agents Therapeutic Uses Hepatitis B, Chronic 2'-fluoro-5-methylarabinosyluracil Hepatitis B DNA Virus Infections Adefovir dipivoxil Adefovir Nucleic Acid Synthesis Inhibitors |