Prednisolone Priming Study in Patients With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title: A Randomized, Double Blind Controlled Trial to Evaluate the Therapeutic Effect of Telbivudine With or Without Prednisolone Priming in Patients With Chronic Hepatitis B

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a Phase IV, multi-center, double-blinded, placebo control randomized study to evaluate the therapeutic effect of telbivudine with or without prednisolone priming in patients with chronic hepatitis B.

Patients are allocated to either group A or B randomly.

Group A: Patients initially receive a 4-week course of oral prednisolone (30 mg daily for 3 weeks and then 15 mg daily of 1 week). After a rest period of no treatment for 2 weeks, the patients receive telbivudine therapy at a daily dose of 600 mg for 2 years. Patients will be asked to come back to clinic for follow-up 6 months after telbivudine treatment.

Group B: Patients receive a 4-week course of placebo. After a rest period of no treatment for 2 weeks, the patients receive telbivudine therapy at a daily dose of 600 mg for 2 years. Patients will be asked to come back to clinic for follow-up 6 months after telbivudine treatment.

Eligible patients will be randomized prior to the first dose of study medication. The visit at which the patient receives the first dose will be defined as the study Baseline. Patients will return to the clinic at 3, 4, 6, 10, 14, 18, 30, 44, 58, 72, 86, 98, 110, 116, 122, 128 and 134 weeks post-Baseline. At each of these visits, routine clinical laboratory tests, adverse event inquiry, and other clinical assessments will be performed. Serum samples for HBV DNA analysis will be obtained at 4, 6, 30, 58, 86, 110 and 134 weeks. Serum samples for HBV sequencing will be obtained at Screening and Week 110 (or upon early termination from the study).

Complete physical examinations will be performed at each study visits to evaluate any adverse signs or symptoms reported by the patient.

Serum for HBeAg, antibody to HBeAg (HBeAb), HBsAg, and antibody to HBsAg (HBsAb) will be obtained at Screening, Baseline, and Weeks 6, 30, 58, 86, 110 and 134(or upon early termination from the study), and at all protocol-required follow-up visits.

Patients will be followed monthly for 6 months after discontinuation of study drug(s). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

• NCT number: NCT00778596
• Study type: Interventional
• Source: Chang Gung Memorial Hospital
• Contact: Mei-Hsia Ku, MS
• Phone: +886-3-3281200
• Email: kuvicky1029@gmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2009
• Completion date: December 2013