Skip to main content
OpenTrials
Completed

NCT Number: NCT00838214

Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autoimmune Hepatitis Autoimmune Diseases Digestive System Diseases Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Liver Diseases

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medical School Hannover

Hanover, Lower Saxony, D-30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

3mg capsule, 3x per day for 6 months

Prednisone

Drug

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

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

    Time frame: 6 months

Secondary outcomes

  1. incidence of biochemical remission

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Dr. Falk Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2008
Study completion
2008
First posted
Feb 6, 2009
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.