Clinical Trial: Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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-Contro

Brief 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.

Detailed Summary:
Sponsor: Dr. Falk Pharma GmbH

Current Primary Outcome: 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 [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: incidence of biochemical remission [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Dr. Falk Pharma GmbH

Dates:
Date Received: February 5, 2009
Date Started: March 2001
Date Completion:
Last Updated: February 5, 2009
Last Verified: February 2009