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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.
Age
10 - 70 years
Sex
ALL
Healthy Volunteers
No
Medical School Hannover
Hanover, Lower Saxony, Germany
Start Date
March 1, 2001
Primary Completion Date
December 1, 2008
Completion Date
December 1, 2008
Last Updated
May 7, 2019
208
ACTUAL participants
budesonide
DRUG
prednisone
DRUG
Lead Sponsor
Dr. Falk Pharma GmbH
NCT04902807
NCT05750498
Data Source & Attribution
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