Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis

Dr. Falk Pharma GmbH208 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

208

Conditions

Autoimmune Hepatitis

Interventions

Eligibility

Sex: ALLMin age: 10 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

incidence of biochemical remission