A study to investigate whether mycophenolate mofetil is more effective than azathioprine in patients with autoimmune hepatitis

Phase 1

• Conditions: Autoimmune hepatitis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-001038-91-BE
• Lead Sponsor: eiden university medical centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-30
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria (table 2) 9:
•Definite autoimmune hepatitis: = 7
•Probable autoimmune hepatitis = 6
2.First presentation of AIH requiring treatment according to the current EASL guidelines
3.Age = 18 years
4.Must provide informed consent and agree to comply with the trial protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1.Overlap syndrome with PSC or PBC (Paris criteria 29, strong positive AMA, past liver biopsy or cholangiographic findings compatible with PBC or PSC).

2.Presence of clinical significant hepatic decompensation including:

•History of liver transplantation, current active placement on a liver transplant waiting list.
•Portal hypertension with complications including: poorly controlled or diuretic resistant ascites, history of variceal bleeding or related therapeutic interventions (e.g. variceal banding, transjugular intrahepatic portosystemic shunts) or hepatic encephalopathy.
•Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, hepatorenal syndrome
a.N.B. cirrhosis without complications as mentioned above, is not an exclusion criterion

3.Current treatment with predniso(lo)ne and/or immunosuppressive medication for an indication other than autoimmune hepatitis

4.Current systemic infection

5.Other clinically significant medical conditions that could interfere with the trial

6.If female of childbearing potential: known pregnancy, or unwilling to practice anticontraceptive measures.

7.History of noncompliance with medical regimens, or patients who are considered to be potentially unreliable or unable to participate

8.Mental instability or incompetence, such that the validity of informed consent or compliance with the trial is uncertain

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified