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

This study has been completed.
Sponsor:
Collaborator:
Pusan National University Hospital
Information provided by (Responsible Party):
Sang Hoon Ahn, Yonsei University
ClinicalTrials.gov Identifier:
NCT00625560
First received: February 11, 2008
Last updated: May 7, 2012
Last verified: May 2012

February 11, 2008
May 7, 2012
February 2008
November 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00625560 on ClinicalTrials.gov Archive Site
  • Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy [ Time Frame: at Week 48 ] [ Designated as safety issue: No ]
  • Percentage number of patients who developed drug resistant mutations while on randomized therapy [ Time Frame: at Week 48 and Week 96 ] [ Designated as safety issue: No ]
  • Change from baseline in mean HBV DNA [ Time Frame: at Week 48 and 96 ] [ 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 ]
Same as current
Not Provided
Not Provided
 
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • Drug: Entecavir
    entecavir 1.0 mg QD
    Other Name: Baraclude 1.0mg
  • Drug: Lamivudine
    lamivudine 100 mg QD
    Other Name: Zeffix 100mg
  • Experimental: A
    entecavir 1.0 mg QD
    Intervention: Drug: Entecavir
  • Active Comparator: B
    lamivudine 100 mg QD
    Intervention: Drug: Lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
November 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00625560
4-2007-0351
Yes
Sang Hoon Ahn, Yonsei University
Yonsei University
Pusan National University Hospital
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 School of Medicine
Yonsei University
May 2012

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