Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
Status and phase
Conditions
Treatments
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
Sex
Ages
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
Allocation
Interventional model
Masking
208 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal