ong term toxicity of azathioprine (Imuran), 6-mercaptopurine (Purinethol)and 6-thioguanine (Lanvis) on the liver in inflammatory bowel disease patients.
- Conditions
- Inflammatory bowel disease, azathioprine, 6-mercaptopurine, 6-thioguanine, hepatotoxicity, liver biopsy.Chronisch inflammatoir darmlijden, azathioprine, 6-mercaptopurine, 6-thioguanine, levertoxiciteit, leverbiopsie.
- Registration Number
- NL-OMON22783
- Lead Sponsor
- Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 114
Inclusion Criteria
1. 18 to 70 years of age;
2. Daignosed with Crohn's disease or ulcerative colitis;
Exclusion Criteria
1. Prior use of azathioprine or 6-mercaptopurine more that one year if using 6-thioguanine;
2. Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above twice the upper limit of the normal range;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Histopathologically proven nodular regenerative hyperplasia or sinusoidal dilatation.
- Secondary Outcome Measures
Name Time Method 1. Ratio of [6-mercaptoribonucleotides] and [6-thioguanine nucleotides];<br /><br>2. Liver test abnormailities;<br /><br>3. Demographic information.<br>