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Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00625560
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : May 8, 2012
Pusan National University Hospital
Information provided by (Responsible Party):
Sang Hoon Ahn, Yonsei University

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Entecavir Drug: Lamivudine Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
entecavir 1.0 mg QD
Drug: Entecavir
entecavir 1.0 mg QD
Other Name: Baraclude 1.0mg

Active Comparator: B
lamivudine 100 mg QD
Drug: Lamivudine
lamivudine 100 mg QD
Other Name: Zeffix 100mg

Primary Outcome Measures :
  1. Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy [ Time Frame: at Week 96 ]

Secondary Outcome Measures :
  1. Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy [ Time Frame: at Week 48 ]
  2. Percentage number of patients who developed drug resistant mutations while on randomized therapy [ Time Frame: at Week 48 and Week 96 ]
  3. Change from baseline in mean HBV DNA [ Time Frame: at Week 48 and 96 ]
  4. Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion [ Time Frame: at Week 48 and 96 ]
  5. Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment [ Time Frame: Follow up period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg positive at baseline.

Exclusion Criteria:

  • All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.
  • Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
  • Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.
  • Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
  • Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00625560

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Korea, Republic of
Pusan National University School of Medicine
Busan, Korea, Republic of, 602-739
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Pusan National University Hospital
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Study Chair: Sang Hoon Ahn, M.D.Ph.D Yonsei Univsersity College of Medicine
Study Director: Do Young Kim, M.D. Yonsei University
Principal Investigator: Jun Yong Park, M.D Yonsei University
Study Director: Jeong Heo, M.D.Ph.D Pusan National University
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Responsible Party: Sang Hoon Ahn, Associate Professor, Yonsei University Identifier: NCT00625560    
Other Study ID Numbers: 4-2007-0351
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012
Keywords provided by Sang Hoon Ahn, Yonsei University:
Chronic hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents