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Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable Hepatitis B Virus DNA

This study has been completed.
Yonsei University
Information provided by (Responsible Party):
Pusan National University Hospital Identifier:
First received: March 4, 2008
Last updated: March 4, 2015
Last verified: March 2015
This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

Condition Intervention Phase
Hepatitis B, Chronic
Drug: Entecavir
Drug: Lamivudine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA

Resource links provided by NLM:

Further study details as provided by Pusan National University Hospital:

Primary Outcome Measures:
  • 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:
  • 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 48 ]
  • Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion [ Time Frame: at Week 48 and 96 ]
  • Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough, Safety assessment [ Time Frame: Follow up period ]

Enrollment: 72
Study Start Date: February 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
entecavir 0.5 mg QD
Drug: Entecavir
entecavir 0.5 mg QD
Other Name: Baraclude 0.5mg
Active Comparator: B
lamivudine 100 mg QD
Drug: Lamivudine
lamivudine 100 mg QD
Other Name: Zeffix 100mg QD

Detailed Description:
Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA < 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. 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   (Adult, Senior)
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 status.

Exclusion Criteria:

  • 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.
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Please refer to this study by its identifier: NCT00637663

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
Pusan National University Hospital
Yonsei University
Study Chair: Jeong Heo, M.D. Ph.D Pusan National University
Study Director: Sang Hoon Ahn, M.D.Ph.D Yonsei Univsersity College of Medicine
Principal Investigator: Jun Yong Park, M.D Yonsei University
  More Information

Responsible Party: Pusan National University Hospital Identifier: NCT00637663     History of Changes
Other Study ID Numbers: 0740-67-5
Study First Received: March 4, 2008
Last Updated: March 4, 2015

Keywords provided by Pusan National University Hospital:
Chronic hepatitis B

Additional relevant MeSH terms:
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 processed this record on April 21, 2017