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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Pusan National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Yonsei University
Information provided by:
Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT00637663
First received: March 4, 2008
Last updated: March 11, 2008
Last verified: March 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ] [ 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 ]

Estimated Enrollment: 200
Study Start Date: February 2008
Estimated Study Completion Date: November 2010
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637663

Contacts
Contact: Jeong Heo, M.D.Ph.D +82-51-240-7869 jheo@pusan.ac.kr
Contact: Jun Yong Park, M.D +82-10-8353-0670 drpjy@yuhs.ac

Locations
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    
Contact: Jun Yong Park, M.D     +82-10-8353-0670     drpjy@yuhs.ac    
Sub-Investigator: Jun Yong Park, M.D            
Sponsors and Collaborators
Pusan National University Hospital
Yonsei University
Investigators
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
Principal Investigator: Jun Yong Park, M.D Yonsei University College of Medicine
  More Information

No publications provided

Responsible Party: Jeong Heo, Department of Internal Medicine, Pusan National University School of Medicine
ClinicalTrials.gov Identifier: NCT00637663     History of Changes
Other Study ID Numbers: 0740-67-5
Study First Received: March 4, 2008
Last Updated: March 11, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pusan National University Hospital:
Chronic hepatitis B
Lamivudine
Entecavir

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Lamivudine
Entecavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013