Status:
COMPLETED
Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Autoimmune Hepatitis
Eligibility:
All Genders
10-70 years
Phase:
PHASE2
PHASE3
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 par...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00838214
Start Date
March 1 2001
End Date
December 1 2008
Last Update
May 7 2019
Active Locations (1)
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1
Medical School Hannover
Hanover, Lower Saxony, Germany, D-30625