Back to resultsMycophenolate vs Azathioprin in Autoimmune Hepatitis
Primary Purpose
Autoimmune Hepatitis
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Treatment with mycophenolat mofetil
Treatment with azathioprin
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Hepatitis focused on measuring Prednisolone dosage
Eligibility Criteria
Inclusion Criteria:
- De novo autoimmune hepatitis
- Consent
Exclusion Criteria:
- age below 18
- pregnancy
Sites / Locations
- Rigshospitalet, Dept. of Hepatology A-2121
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
I
II
Arm Description
MMF
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00687180
Brief Title
Mycophenolate vs Azathioprin in Autoimmune Hepatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
A study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10 receiving mycophenolat mofetil.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis
Keywords
Prednisolone dosage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Active Comparator
Arm Description
MMF
Arm Title
II
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Treatment with mycophenolat mofetil
Intervention Type
Drug
Intervention Name(s)
Treatment with azathioprin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
De novo autoimmune hepatitis
Consent
Exclusion Criteria:
age below 18
pregnancy
Facility Information:
Facility Name
Rigshospitalet, Dept. of Hepatology A-2121
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
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Mycophenolate vs Azathioprin in Autoimmune Hepatitis
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