Chronic Hepatitis B, Inadequate Response, Nucleos(t)Ide Analogues Treatment
Conditions
Brief summary
The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy
Interventions
Sponsors
Major Science and Technology Special Project of China Eleventh Five-year
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who completed the 104-week Dragon 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 in each group | Week 144 |
Secondary
| Measure | Time frame |
|---|---|
| Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group. | 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