Chronic Hepatitis B
Conditions
Keywords
Experienced Treatment
Brief summary
The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.
Interventions
DRUGoral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Sponsors
Major Science and Technology Special Project of China 12th Five-year
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study. * Subjects who are willing to participate the extension study.
Exclusion criteria
* Subjects who could not compliance with the protocol judged by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentages of patients achieving HBV DNA< 300copies/mL at week 144 | Week 144 |
Secondary
| Measure | Time frame |
|---|---|
| Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 | Week 48 & 96 |
| The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144 | Week 48 & 96 &144 |
| Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144. | Week 48 & 96 & 144 |
| Percentage of patients with ALT normalization at week 48/96/144 | Week 48 & 96 & 144 |
Countries
China
Outcome results
None listed