NCT00838214

Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autoimmune Hepatitis

Interventions

Type	Name	Description
DRUG	budesonide	3mg capsule, 3x per day for 6 months
DRUG	prednisone	5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months

Timeline

• Start date: 2001-03-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2009-02-06
• Last updated: 2019-05-07

Locations

1 site across 1 country: Germany