adult patients (18-70 years old) who have been treated with azathioprine, 6-mercaptopure or 6-thioguanine for inflammatory bowel disease, in whom hepatotoxicity occured as an adverse event, are eligible. Prior to definite inclusion, the patients will be screened to make other causes of hepatotoxicity less likely.
Conditions
Interventions
Trade Name: acetylcysteine
Product Name: acetylcysteine
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: ACETYLCYSTEINE
CAS Number: 616911
Concentration unit: mg milligram(s)
Concentratio
Sponsors
VU university medical centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: written informed consent; adult patients, aged between 18 and 70 years; Crohn's disease or ulcerative colitis; azathioprine, 6-mercaptopurine or 6-thioguanine therapy, Grade 1 or 2 on the CTCAE v3.0 of at least one of the following liver tests: aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (AP), gamma-glutamyl transferase (GGT) or total bilirubine (Bili). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Serological findings consistent with active viral hepatitis A, B, C EBV or CMV; findings suggesting auto-immune hepatitis (AIH); cholestasis; known liver diseases inlcuding: Hepatitis A, B or C, cirrhosis, AIH, primary sclerosing cholangitis, primary biliairy cirrhosis, hepatocellular carcinoma, metastatic liver disease or symptomatic cholecystolithiasis; Use of methotrexate or other chemotherapy within the last three months; use of N-acetylcysteine during thioipurine therapy; allergy to N-acetylcysteine; lactation; pregnancy; 6-TGN level >1200 pmol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the influence of acetylcysteine co-administartion on thiopurine induced hepatotoxicity.;Secondary Objective: - To study the influence of acetylcysteine co-administration on markers for oxidative stress - To study the influence of acetylcysteine co-administration on thiopurine metabolism;Primary end point(s): Changes in liver tests ASAT, ALAT, GGT, AF and Bili. | — |
Countries
Netherlands
Outcome results
None listed