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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Entecavir
Lamivudine
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Chronic hepatitis B, Lamivudine, Entecavir

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pusan National University School of Medicine
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

entecavir 1.0 mg QD

lamivudine 100 mg QD

Outcomes

Primary Outcome Measures

Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy

Secondary Outcome Measures

Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy
Percentage number of patients who developed drug resistant mutations while on randomized therapy
Change from baseline in mean HBV DNA
Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion
Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment

Full Information

First Posted
February 11, 2008
Last Updated
May 7, 2012
Sponsor
Yonsei University
Collaborators
Pusan National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00625560
Brief Title
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
Collaborators
Pusan National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Chronic hepatitis B, Lamivudine, Entecavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
entecavir 1.0 mg QD
Arm Title
B
Arm Type
Active Comparator
Arm Description
lamivudine 100 mg QD
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Baraclude 1.0mg
Intervention Description
entecavir 1.0 mg QD
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Other Intervention Name(s)
Zeffix 100mg
Intervention Description
lamivudine 100 mg QD
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy
Time Frame
at Week 48
Title
Percentage number of patients who developed drug resistant mutations while on randomized therapy
Time Frame
at Week 48 and Week 96
Title
Change from baseline in mean HBV DNA
Time Frame
at Week 48 and 96
Title
Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion
Time Frame
at Week 48 and 96
Title
Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment
Time Frame
Follow up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Hoon Ahn, M.D.Ph.D
Organizational Affiliation
Yonsei Univsersity College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Do Young Kim, M.D.
Organizational Affiliation
Yonsei University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jun Yong Park, M.D
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeong Heo, M.D.Ph.D
Organizational Affiliation
Pusan National University
Official's Role
Study Director
Facility Information:
Facility Name
Pusan National University School of Medicine
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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

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