Trial Details

Not Recruiting
Basic Information
Clinical ID c3271
Identifier ISRCTN58287360
Trial Title Retrospective and prospective evaluation of the pharmacogenetics and metabolites of thiopurine drugs in the treatment of inflammatory bowel disease: a self-controlled trial and a randomised controlled trial
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory bowel disease Digestive System Other noninfective gastroenteritis and colitis
Interventions Retrospective self-controlled trial: Retrospectively assess the impact of genetic variation and concentration of metabolites on efficacy and toxicity of AZA/6-MP in patients with IBD. Drug dose was started at 1 mg/kg daily for AZA (Imurel, GlaxoSmithKline, Sweden) and 0.5 mg/kg daily for 6-MP (Puri-Nethersole, GlaxoSmithKline, Sweden) in the first week, then increased to 2 mg/kg daily for AZA and 1.0 mg/kg daily for 6-MP without dose alteration in following weeks. Clinical data including sex, age, age at diagnosis and site of disease, type of inflammatory bowel disease, weight, dose of AZA/6-MP, indication for AZA/6-MP therapy, concomitant therapy (5-aminosalicylates, infliximab or other drugs), and toxicity data including full blood counts and liver function tests were collected. Patient information such as disease activity scores were collected by a physician. Haematotoxicity observed as myelosuppression included leukopaenia and neutropaenia. Leukopaenia was defined as a leukocyte count (white blood cell [WBC]) less than 3.5 x 10^9/L, and neutropaenia was defined as less than 1.5 x 10^9/L neutrophils. Each decrease of WBC and neutrophils should be continuously observed in two days, and recovered in the next one or two weeks after AZA/6-MP withdrawal. Hepatotoxicity was defined as an increase in transaminases at least two times higher than the normal value. Pancreatitis was diagnosed when compatible symptoms (abdominal pain) were present and serum amylase was increased two times above the upper normal limit. Flu-like symptoms included febris, headache, courbature and arthralgia all over the body while gastrointestinal intolerance was defined as hypogeusia, nausea and vomiting. 2 ml venous blood samples were taken prior to treatment for genetic variation detecting. The genotypes of TPMT, glutathione S-transferase (GST), inosine triphosphatase (ITPA) were measured by technique based-on polymerase chain reaction (PCR). The activities of TPMT, HPRT, GST, xanthine oxi
Participant Information
Sponsor Sun Yat-sen University (China)
City -
Country/Region China
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -