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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:  NCT02900443
Date of registration: 17/08/2016
Prospective Registration: Yes
Primary sponsor: Radboud University
Public title: Mycophenolate Mofetil Versus Azathioprine in Treatment Naive Autoimmune Hepatitis CAMARO
Scientific title: A Randomised, Open-label Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Naive Autoimmune Hepatitis
Date of first enrolment: January 2017
Target sample size: 70
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT02900443
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Netherlands
Contacts
Name:     Simon Pape, MD
Address: 
Telephone: +31652621030
Email: Simon.Pape@radboudumc.nl
Affiliation: 
Name:     Bart van Hoek, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Leiden University Medical Center
Name:     Joost PH Drenth, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Radboud University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Probable or definite diagnosis of autoimmune hepatitis according to the International
Autoimmune Hepatitis Study Group criteria

- First presentation of AIH requiring treatment according to the current EASL guidelines

- Age = 18 years

- Must provide informed consent and agree to comply with the trial protocol

Exclusion Criteria:

- Overlap syndrome with Primary Sclerosing Cholangitis (PSC) or Primary Biliary
Cholangitis (PBC) (Paris criteria, strong positive Anti-Mitochondrial Antibodies
(AMA), past liver biopsy or cholangiographic findings compatible with PBC or PSC).

- Presentation with acute liver failure, defined as presence of hepatic encephalopathy
and coagulopathy (INR > 1.5)

- Current treatment with prednisone/prednisolone and/or immunosuppressive medication for
an indication other than autoimmune hepatitis

- Current systemic infection

- Other clinically significant medical conditions that could interfere with the trial

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

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Autoimmune Hepatitis
Intervention(s)
Drug: Azathioprine
Drug: Mycophenolate mofetil
Primary Outcome(s)
Biochemical remission [Time Frame: 24 weeks]
Secondary Outcome(s)
Biochemical remission at any time [Time Frame: Up to 24 weeks]
Bone fractures [Time Frame: Up to 24 weeks]
Changes in liver stiffness, measured by transient elastography [Time Frame: Up to 24 weeks]
Changes in quality of life measured with Short Form Health survey 36 (SF-36) [Time Frame: Up to 24 weeks]
De novo onset of diabetes mellitus (requiring medication) [Time Frame: Up to 24 weeks]
Extrahepatic AIH manifestations (e.g. arthralgia) [Time Frame: Up to 24 weeks]
Fatigue index [Time Frame: Up to 24 weeks]
Glaucoma [Time Frame: Up to 24 weeks]
Hypertension (requiring medication) [Time Frame: Up to 24 weeks]
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN [Time Frame: Up to 24 weeks]
N-terminal procollagen-III-peptide, ELF score [Time Frame: Up to 24 weeks]
Number of infections [Time Frame: Up to 24 weeks]
Number of patients with treatment related adverse events per treatment group [Time Frame: Up to 24 weeks]
Osteoporosis (confirmed by bone densitometry) [Time Frame: Up to 24 weeks]
Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN [Time Frame: Up to 24 weeks]
Patient survival [Time Frame: Up to 24 weeks]
Percentage of patients with biochemical remission [Time Frame: Up to 24 weeks]
Pruritis VAS score [Time Frame: Up to 24 weeks]
Ratio of ALT to lowest ALT ever [Time Frame: Up to 24 weeks]
Steroid and other side-effects scores consisting of Visual Analogue Scores (VAS) scores (0 - 10) by the physician for Cushing-face, buffalo hump, acne, striae, bruising and hirsutism. [Time Frame: Up to 24 weeks]
The level of liver enzymes in both groups [Time Frame: Up to 24 weeks]
Time to biochemical remission [Time Frame: 24 weeks]
Treatment failure, defined as no improvement or increase of ALT or AST serum levels [Time Frame: Up to 24 weeks]
Secondary ID(s)
NL57115.058.16
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Leiden University Medical Center
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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