Back to resultsBudesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
Primary Purpose
Autoimmune Hepatitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
budesonide
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Hepatitis
Eligibility 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
Sites / Locations
- Medical School Hannover
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
budesonide
prednisone
Arm Description
3mg capsules 3x/day for 6 months
5mg tablet, 40mg starting dose titrated to 10mg over 3 months
Outcomes
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
Secondary Outcome Measures
incidence of biochemical remission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00838214
Brief Title
Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
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 Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dr. Falk Pharma GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
budesonide
Arm Type
Experimental
Arm Description
3mg capsules 3x/day for 6 months
Arm Title
prednisone
Arm Type
Active Comparator
Arm Description
5mg tablet, 40mg starting dose titrated to 10mg over 3 months
Intervention Type
Drug
Intervention Name(s)
budesonide
Intervention Description
3mg capsule, 3x per day for 6 months
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
incidence of biochemical remission
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael M Manns, Professor
Organizational Affiliation
University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
D-30625
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20600032
Citation
Manns MP, Woynarowski M, Kreisel W, Lurie Y, Rust C, Zuckerman E, Bahr MJ, Gunther R, Hultcrantz RW, Spengler U, Lohse AW, Szalay F, Farkkila M, Prols M, Strassburg CP; European AIH-BUC-Study Group. Budesonide induces remission more effectively than prednisone in a controlled trial of patients with autoimmune hepatitis. Gastroenterology. 2010 Oct;139(4):1198-206. doi: 10.1053/j.gastro.2010.06.046. Epub 2010 Jun 22.
Results Reference
result
PubMed Identifier
23810723
Citation
Woynarowski M, Nemeth A, Baruch Y, Koletzko S, Melter M, Rodeck B, Strassburg CP, Prols M, Wozniak M, Manns MP; European Autoimmune Hepatitis-Budesonide Study Group. Budesonide versus prednisone with azathioprine for the treatment of autoimmune hepatitis in children and adolescents. J Pediatr. 2013 Nov;163(5):1347-53.e1. doi: 10.1016/j.jpeds.2013.05.042. Epub 2013 Jun 28.
Results Reference
derived
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Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
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