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Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

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Dr. Falk Pharma

Status and phase

Completed
Phase 3
Phase 2

Conditions

Autoimmune Hepatitis

Treatments

Drug: prednisone
Drug: budesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00838214
BUC-38/AIH

Details and patient eligibility

About

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.

Enrollment

208 patients

Sex

All

Ages

10 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

208 participants in 2 patient groups

budesonide
Experimental group
Description:
3mg capsules 3x/day for 6 months
Treatment:
Drug: budesonide
prednisone
Active Comparator group
Description:
5mg tablet, 40mg starting dose titrated to 10mg over 3 months
Treatment:
Drug: prednisone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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