|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00838214 |
|
Date of registration:
|
05/02/2009 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis
|
|
Scientific title:
|
Efficacy and Safety of Budesonide Capsules (3x3mg/d)Versus Prednisone in Patients With a Diagnose of Active Autoimmune Hepatitis. A Double-blind, Randomized, Active-controlled, Multicentre Study |
|
Date of first enrolment:
|
March 2001 |
|
Target sample size:
|
208 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00838214 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Michael M Manns, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
10 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Autoimmune Hepatitis
|
|
Intervention(s)
|
|
Drug: prednisone
|
|
Drug: budesonide
|
|
Primary Outcome(s)
|
|
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 Outcome(s)
|
|
incidence of biochemical remission
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
BUC-38/AIH
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|