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Long term toxicity of azathioprine (Imuran), 6-mercaptopurine (Purinethol)and 6-thioguanine (Lanvis) on the liver in inflammatory bowel disease patients.


- candidate number6422
- NTR NumberNTR1992
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-sep-2009
- Secondary IDs09/030 METC VUMC
- Public TitleLong term toxicity of azathioprine (Imuran), 6-mercaptopurine (Purinethol)and 6-thioguanine (Lanvis) on the liver in inflammatory bowel disease patients.
- Scientific TitleLong term hepatotoxicity of azathioprine, 6-mercaptopurine and 6-thioguanine in inflammatory bowel disease.
- ACRONYMLONGTOX
- hypothesisLong-term use of 6-thioguanine is more hepatotoxic, based on histopathological findings, as compared with the long-term use of azathioprine and 6-mercaptopurine in inflammatory bowel disease patients.
- Healt Condition(s) or Problem(s) studiedAzathioprine , Hepatotoxicity, 6-mercaptopurine, 6-thioguanine, Chronic inflammatory bowel disease, Liver biopsy
- Inclusion criteria1. 18 to 70 years of age;
2. Daignosed with Crohn's disease or ulcerative colitis;
3. Five to ten years use of one type of thiopurine succesively;
4. Obtained written informed consent.
- Exclusion criteria1. 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;
3. Contraindications for core needle liver biopsy (ascites, suspected malignancy, anemia, low platelet count, prolonged prothrombin time);
4. Pregnancy;
5. (History of) alcohol abuse;
6. Incapacitated.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 10-jan-2009
- planned closingdate10-jan-2011
- Target number of participants114
- Interventions1. Liver biopsy;
2. Venapuncture;
3. Abdominal ultrasonography;
4. Physical examination;
5. A questionnaire.
- Primary outcomeHistopathologically proven nodular regenerative hyperplasia or sinusoidal dilatation.
- Secondary outcome1. Ratio of [6-mercaptoribonucleotides] and [6-thioguanine nucleotides];
2. Liver test abnormailities;
3. Demographic information.
- TimepointsAfter identification and when written informed consent is obtained, patients will visit the hospital onze for the above mentioned interventions.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES D.P. Asseldonk, van
- CONTACT for SCIENTIFIC QUERIES D.P. Asseldonk, van
- Sponsor/Initiator VU University Medical Center, Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Department of Gastroenterology and Hepatology
- PublicationsN/A
- Brief summaryThiopurines, such as azathioprine, 6-mercaptopurine and 6-thioguanine are increasingly used in the treatment of the inflammatory bowel diseases Crohn's disease and ulcerative colitis. Thiopurine therapy, 6-thioguanine therapy in particular, has been related with the occurence of hepatotoxicity. At present there are no studies in which the hepatotoxicity of these thiopurines are being compared by means of histopathological evaluation. This study will give more insight in the hepatotoxicity of these drugs in inflammatory bowel disease patients, which may have implications for the long-term use of these drugs.
- Main changes (audit trail)
- RECORD7-sep-2009 - 12-okt-2009


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