Autoimmune Hepatitis
Conditions
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.
Interventions
DRUGbudesonide
3mg capsule, 3x per day for 6 months
DRUGprednisone
5mg tablet, 40mg starting dose per day, titration to 10mg per day within 3 months
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| incidence of biochemical remission | 6 months |
Countries
Germany
Outcome results
None listed