Status:
COMPLETED
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
Lead Sponsor:
Yonsei University
Collaborating Sponsors:
Pusan National University Hospital
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 tre...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00625560
Start Date
February 1 2008
End Date
November 1 2010
Last Update
May 8 2012
Active Locations (2)
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1
Pusan National University School of Medicine
Busan, Busan, South Korea, 602-739
2
Severance Hospital
Seoul, Seoul, South Korea, 120-752