Autoimmune Hepatitis Clinical Trial
Official title:
Efficacy and Safety of Budesonide Capsules (3x3mg/d)Versus Prednisone in Patients With a Diagnose of Active Autoimmune Hepatitis. A Double-blind, Randomized, Active-controlled, Multicentre Study
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.
n/a
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