Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Budesonide; Prednisone

Criteria

Inclusion Criteria:

• age 10 to 70 years

• Diagnosis of acute AIH according to Alvarez score

• normal range of TPMT activity

• normal ACTH test

• negative pregnancy test at screening for females of childbearing potential

• written informed consent

Exclusion Criteria:

• presence of Hepatitis A, B, C, E or G virus infection

• liver cirrhosis or clinical signs of portal hypertension

• PBC

• PSC

• history of hypersensitivity to the study medication