Retrospective and prospective evaluation of the pharmacogenetics and metabolites of thiopurine drugs in the treatment of inflammatory bowel disease
- Conditions
- Inflammatory bowel diseaseDigestive SystemOther noninfective gastroenteritis and colitis
- Registration Number
- ISRCTN58287360
- Lead Sponsor
- Sun Yat-sen University (China)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 170
1. All consecutive patients with the diagnosis of IBD who received the azathioprine treatment at the Gastroenterology Outpatient Clinic of the First Affiliated Hospital of Sun Yat-sen University
2. Aged from 3 - 74 years, either sex
3. Steroid-dependent disease: unable to reduce corticosteroids below the equivalent of prednisolone 15 mg/day (or budesonide below 3 mg/day) within three months of starting corticosteroids or relapse within three months of stopping corticosteroids
4. Frequent relapses: greater than three relapses in one year or greater than two relapses in six months
5. Remission maintenance
6. Post-operative prophylaxis
1. Blood transfusion or administration of cyclosporine or methotrexate (MTX) within the last 3 months
2. Treatments potentially interfering with AZA metabolism, including allopurinol and diuretics
3. Insufficient function in heart, liver or kidney
4. Active infection
5. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Distribution of TPMT, HPRT, GST, XO, ITPA and IMPDH polymorphisms in Chinese IBD patients<br>2. The impact of genetic variation on efficacy and toxicity of AZA/6-MP in patients with IBD<br>3. The therapeutic and safe concentration threshold of 6-TGNs in Chinese IBD patients undergoing AZA/6-MP therapy
- Secondary Outcome Measures
Name Time Method