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Prednisolone Priming Study in Patients With Chronic Hepatitis B

NCT00778596 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2012-05-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Prednisolone

Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.

DRUG

Placebo priming

Prednisolone priming for 4 weeks, then followed a telbivudine treatment for 2 years.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Yun-Fan Liaw

    lead OTHER

Principal Investigators

  • Yun-Fan Liaw, MD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-12-31
Completion
2013-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778596 on ClinicalTrials.gov