Prednisolone Priming Study in Patients With Chronic Hepatitis B

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.

Timeline

Start

2009-02

Primary completion

2012-12

Completion

2013-12

Drugs

Indications