Clinical trial NCT00838214: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Autoimmune Hepatitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 208
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: incidence of biochemical remission
timeFrame: 6 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
state: Niedersachsen
Study officials:
affiliation: University Hospital
name: Michael M Manns, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.