Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA

This study has been completed.
Pusan National University Hospital
Information provided by (Responsible Party):
Sang Hoon Ahn, Yonsei University Identifier:
First received: February 19, 2008
Last updated: May 7, 2012
Last verified: May 2012
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
Endpoint Classification: Safety/Efficacy Study
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 Yonsei University:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion [ Time Frame: at Week 48 and 96 ] [ Designated as safety issue: No ]
  • Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough, Safety assessment [ Time Frame: Follow up period ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00625339

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
Study Chair: Jeong Heo, M.D. Ph.D Pusan National University School of Medicine
Study Director: 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
  More Information

Responsible Party: Sang Hoon Ahn, Associate Professorr, Yonsei University Identifier: NCT00625339     History of Changes
Other Study ID Numbers: 4-2007-0367 
Study First Received: February 19, 2008
Last Updated: May 7, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
DNA Virus Infections
Digestive System Diseases
Hepadnaviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors processed this record on May 24, 2016