Status:
UNKNOWN
Tacrolimus Versus Mycophenolate for Autoimmune Hepatitis Patients With Incomplete Response on First Line Therapy
Lead Sponsor:
Leiden University Medical Center
Conditions:
Autoimmune Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rationale: The combination of azathioprine and prednisone is the first-line treatment for autoimmune hepatitis (AIH), a chronic inflammatory disease of the liver. Complete biochemical remission (CR) i...
Eligibility Criteria
Inclusion
- Patient is older than 18 years old
- Probable or definite auto immune hepatitis according to the original or simplified IAIHG criteria (\>10 points pre-treatment on the original criteria or \>6 points on the simplified criteria)(2, 3)
- Incomplete responder on at least a half year of first-line treatment, with at least last 6 months azathioprine / 6-MP) / 6-TG and prednisolone or budesonide, and ALT 1.5 - 10x ULN for at least 2 months
- Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study
Exclusion
- Presence of decompensated liver disease, defined as ascites, coagulopathy (INR \>1.5), encephalopathy, variceal bleed, hepatopulmonal syndrome, hepatorenal syndrome or HCC in the past 6 months
- Signs of other liver diseases as NAFLD, Wilson disease, hemochromatosis, alcoholic liver disease or hepatitis B/C/D
- Clinical diagnosis of overlap / variant syndrome with PBC or PSC
- Liver transplantation in the medical history or currently on the waiting list for liver transplantation
- Incompliance with therapy during the last 12 months
- Active infections during inclusion including latent tuberculosis and HIV co-infection
- Allergic or hypersensitive to tacrolimus or MMF
- An estimated glomerular filtration rate (eGFR) of \<60 mL/min
- Pregnancy or intention to become pregnant in the next 12 months
- Use of TAC or MMF in the past
- Malignancy in the medical history
Key Trial Info
Start Date :
January 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05221411
Start Date
January 19 2022
End Date
January 1 2024
Last Update
February 3 2022
Active Locations (6)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
2
Reinier de Graaf Gasthuis
Delft, Netherlands
3
Medisch Spectrum Twente
Enschede, Netherlands
4
Leiden University Medical Center
Leiden, Netherlands