Inflammatory bowel disease
Conditions
Interventions
Continuation of thiopurine treatment during eight weeks. During four weeks 600mg N-acetylcysteine effervescent tablets four times daily.
Sponsors
VU University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Crohn's disease and ulcerative colitis; 2. Patients between 18 and 70 years old; 3. Thiopurine use (azathioprine, 6-mercaptopurine or 6-thioguanine) for at least eight consecutive weeks; 4. Grade 1 or 2 toxicity on the CTCAEv3.0 of at least one of the folowing liver tests: ALAT, ASAT, gamma-GT, alkaline phosphatase and bilirubine.
Exclusion criteria
Exclusion criteria: 1. Serological findings consistent with auto-immune or viral hepatitis (Hep A,B,C; EBV; CMV); 2. Currently known liver disease; 3. History of chemotherapy; 4. Ultrasonographic findings consistent with cholestasis; 5. Lactation or pregnancy; 6. 6-TGN concentrations above 1200 pmol/8x10*8; 7. Use of antioxidants during thiopurine therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in liver tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in state of oxidative stress (plasma malondialdehyde, plasma myeloperoxidase, urinary 8-hydroxy- deoxyguanosine and urinary F2-isoprostane); 2. Change in plasma xanthine oxidase activity; 3. Change in amino acid profile. | — |
Contacts
Public ContactD.P. Asseldonk, van
Outcome results
None listed