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Budesonide 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
Dr. Falk Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Hepatitis

Eligibility Criteria

10 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 5, 2009
Last Updated
May 3, 2019
Sponsor
Dr. Falk Pharma GmbH
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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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