Status:
COMPLETED
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, \<300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assa...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Nucleoside and nucleotide-naive subjects with chronic HBV infection
- Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
- Detectable HBsAg
- HBV DNA ≥ 105 copies/mL by PCR
- ALT 1.3 to 10 x the ULN
- HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00393484
Start Date
February 1 2007
End Date
September 1 2013
Last Update
November 26 2014
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Bucheon-si, South Korea, 420-717
2
Local Institution
Busan, South Korea, 602-739
3
Local Institution
Chuncheon, South Korea, 200-704
4
Local Institution
Daegu, South Korea, 700-721