NCT00838214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

7.8 years

First QC Date

February 5, 2009

Last Update Submit

May 3, 2019

Conditions

Autoimmune Hepatitis

Outcome Measures

Primary Outcomes (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

    6 months

Secondary Outcomes (1)

  • incidence of biochemical remission

    6 months

Study Arms (2)

budesonide

EXPERIMENTAL

3mg capsules 3x/day for 6 months

Drug: budesonide

prednisone

ACTIVE COMPARATOR

5mg tablet, 40mg starting dose titrated to 10mg over 3 months

Drug: prednisone

Interventions

budesonideDRUG

3mg capsule, 3x per day for 6 months

budesonide
prednisoneDRUG

5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months

prednisone

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical School Hannover

Hanover, Lower Saxony, D-30625, Germany

Location

Related Publications (2)

  • 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.

    PMID: 20600032RESULT

  • 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.

    PMID: 23810723DERIVED

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

BudesonidePrednisone

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsPregnadienes

Study Officials

  • Michael M Manns, Professor

    University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 6, 2009

Study Start

March 1, 2001

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

DE(1)