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Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

This study has been completed.
Information provided by:
Dr. Falk Pharma GmbH Identifier:
First received: February 5, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

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.

Condition Intervention Phase
Autoimmune Hepatitis Drug: budesonide Drug: prednisone Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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-Controlled, Multicentre Study

Resource links provided by NLM:

Further study details as provided by Dr. Falk Pharma GmbH:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 208
Study Start Date: March 2001
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: budesonide
3mg capsules 3x/day for 6 months
Drug: budesonide
3mg capsule, 3x per day for 6 months
Active Comparator: prednisone
5mg tablet, 40mg starting dose titrated to 10mg over 3 months
Drug: prednisone
5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months


Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00838214

Medical School Hannover
Hannover, Niedersachsen, Germany, D-30625
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Michael M Manns, Professor University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Markus Proels, Dr. Falk Pharma, Germany Identifier: NCT00838214     History of Changes
Other Study ID Numbers: BUC-38/AIH
Study First Received: February 5, 2009
Last Updated: February 5, 2009

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on August 16, 2017