Prednisolone Priming Study in Patients With Chronic Hepatitis B
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Study purpose:
To investigate whether ALT rebound following corticosteroid priming enhances response to
telbivudine therapy.
Efficacy assessments:
The primary endpoint will be the 1-year HBe-Ag seroconversion rate with or without
prednisolone priming.
Data analysis:
A summary table will be presented as frequency tables for categorical variables as number,
and percentage, whereas descriptive tables for continuous variables as number, mean ± SD and
median (minimum, maximum). All statistical assessments will be two-sided and evaluated at
significance level of 0.05. Continuous variables will be analyzed using t-test, or ANOVA, and
categorical variables will be analyzed using chi-square or Fisher's exact test. A
non-parametric method, Wilcoxon rank-sum or sign-rank tests will be conducted for continuous,
and categorical variables if data is far from normal distribution.