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Sponsors and Collaborators: |
Yonsei University Pusan National University Hospital |
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Information provided by: | Yonsei University |
ClinicalTrials.gov Identifier: | NCT00625560 |
This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.
Condition | Intervention | Phase |
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Hepatitis B, Chronic |
Drug: Entecavir Drug: Lamivudine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA |
Estimated Enrollment: | 72 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
entecavir 1.0 mg QD
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Drug: Entecavir
entecavir 1.0 mg QD
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B: Active Comparator
lamivudine 100 mg QD
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Drug: Lamivudine
lamivudine 100 mg QD
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Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sang Hoon Ahn, M.D.Ph.D | +82-2-2228-1930 | ahnsh@yuhs.ac |
Contact: Jun Yong Park, M.D. | +82-10-8353-0670 | drpjy@yuhs.ac |
Korea, Republic of | |
Pusan National University School of Medicine | Recruiting |
Busan, Korea, Republic of, 602-739 | |
Contact: Jeong Heo, M.D.Ph.D +82-51-240-7869 jheo@pusan.ac.kr | |
Principal Investigator: Jeong Heo, M.D.Ph.D | |
Severance Hospital | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Contact: Sang Hoon Ahn, M.D.Ph.D +82-11-419-8087 ahnsh@yuhs.ac | |
Principal Investigator: Jun Yong Park, M.D. |
Study Chair: | Sang Hoon Ahn, M.D.Ph.D | Yonsei Univsersity College of Medicine |
Study Director: | Do Young Kim, M.D. | Yonsei University College of Medicine |
Principal Investigator: | Jun Yong Park, M.D | Yonsei University College of Medicine |
Study Director: | Jeong Heo, M.D.Ph.D | Pusan National University School of Medicine |
Responsible Party: | Department of Internal Medicine, Yonsei University College of Medicine ( Sang Hoon Ahn ) |
Study ID Numbers: | 4-2007-0351 |
Study First Received: | February 11, 2008 |
Last Updated: | February 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00625560 |
Health Authority: | Korea: Food and Drug Administration |
Chronic hepatitis B Lamivudine Entecavir |
Virus Diseases Hepatitis Liver Diseases Entecavir Digestive System Diseases Hepatitis, Chronic |
Hepatitis B, Chronic Hepatitis B Lamivudine Hepatitis, Viral, Human DNA Virus Infections |
Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Reverse Transcriptase Inhibitors |