Status:
WITHDRAWN
Entecavir Plus Adefovir in Lamivudine-Resistant Patients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adul...
Eligibility Criteria
Inclusion
- CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
- Naïve to nucleoside/nucleotide analogues except for LVD
- HBV DNA \> 17,200 IU/mL
- Compensated liver function
- Serum ALT \<10 × ULN
Exclusion
- Women who are pregnant or breastfeeding
- Evidence of decompensated cirrhosis
- Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00986778
Start Date
December 1 2009
End Date
June 1 2014
Last Update
September 1 2015
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