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Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

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ClinicalTrials.gov Identifier: NCT00838214
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : May 7, 2019
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Drug: budesonide Drug: prednisone Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : March 2001
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. incidence of biochemical remission [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 70 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838214

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Medical School Hannover
Hannover, Niedersachsen, Germany, D-30625
Sponsors and Collaborators
Dr. Falk Pharma GmbH
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Principal Investigator: Michael M Manns, Professor University Hospital
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Markus Proels, Dr. Falk Pharma, Germany
ClinicalTrials.gov Identifier: NCT00838214    
Other Study ID Numbers: BUC-38/AIH
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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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