Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This is a multicentre, multinational clinical study. It comprised two consecutive segments (A
and B). Segment A was designed as a randomized, double-blind, double-dummy,
active-controlled, two-arm parallel-group study. The patients received either budesonide or
prednisone for 6 months. During segment B all patients received budesonide as an open
treatment for additional 6 months.
In this confirmatory study the proportion of patients with complete response was compared
between the two treatment groups. Complete response was defined as biochemical remission
(=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of segment
A and lack of steroid specific side effects throughout segment A.