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Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable 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.
 
ClinicalTrials.gov Identifier: NCT00625339
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : May 8, 2012
Sponsor:
Collaborator:
Pusan National University Hospital
Information provided by (Responsible Party):
Sang Hoon Ahn, Yonsei University

Tracking Information
First Submitted Date  ICMJE February 19, 2008
First Posted Date  ICMJE February 28, 2008
Last Update Posted Date May 8, 2012
Study Start Date  ICMJE February 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
  • 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 developed drug resistant mutations while on randomized therapy [ Time Frame: at Week 48 and Week 96 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis B, Chronic
Intervention  ICMJE
  • Drug: Entecavir
    entecavir 0.5 mg QD
    Other Name: Baraclude 0.5mg
  • Drug: Lamivudine
    lamivudine 100 mg QD
    Other Name: Zeffix 100mg QD
Study Arms  ICMJE
  • Experimental: A
    entecavir 0.5 mg QD
    Intervention: Drug: Entecavir
  • Active Comparator: B
    lamivudine 100 mg QD
    Intervention: Drug: Lamivudine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2012)
72
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2008)
200
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00625339
Other Study ID Numbers  ICMJE 4-2007-0367
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang Hoon Ahn, Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Pusan National University Hospital
Investigators  ICMJE
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
Study Director: Do Young Kim, M.D Yonsei University
Principal Investigator: Jun Yong Park, M.D Yonsei University
PRS Account Yonsei University
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP