Hepatitis B, Chronic
Conditions
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 adults with lamivudine-resistant chronic hepatitis B infection
Interventions
DRUGLamivudine
Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response
DRUGEntecavir
Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response
DRUGAdefovir
Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Women who are pregnant or breastfeeding * Evidence of decompensated cirrhosis * Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with HBV DNA < 50 IU/mL at W48 | Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Mean reduction of HBV DNA at W 48 & 96 | Week 48 and 96 |
| The proportion of subjects with ALT normalization at W 48 & 96 | Week 48 & Week 96 |
| The proportion of patient with HBV DNA < 50 IU/mL at W 96 | Week 96 |
| Safety | Week 48 and Week 96 |
| Resistance | Week 48 & Week 96 |
| The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96 | Week 48 & 96 |
Outcome results
None listed