Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

Phase 2

Completed

• Conditions: Autoimmune Hepatitis
• Interventions: Drug: budesonide; Drug: prednisone

• Registration Number: NCT00838214
• Lead Sponsor: Dr. Falk Pharma GmbH

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 Description

Not available

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2009-02-05
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
budesonide	budesonide	3mg capsules 3x/day for 6 months
prednisone	prednisone	5mg tablet, 40mg starting dose titrated to 10mg over 3 months

Primary Outcome Measures

Name	Time	Method
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	6 months

Secondary Outcome Measures

Name	Time	Method
incidence of biochemical remission	6 months

Trial Locations

Locations (1)

Medical School Hannover; 🇩🇪 Hannover, Niedersachsen, Germany