A 6-thioguanine (6-TG) registry that explores the effectiveness and safety of 6-TG in the long-term treatment of inflammatory bowel disease (IBD)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective non-interventional registry

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L01BB03) tioguanine

  tioguanine
• Medical condition to be studied:
  Inflammatory bowel disease

Population studied

• Short description of the study population:
  Inflammatory bowel disease (IBD) patients using Thiosix.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  87

Study design details

• Main study objective:
  Monitoring of the incidence of NRHExamine the safety of treatment with 6-thioguanineFollow-up on long-term efficacy of 6- thioguanine treatmentMonitoring of patient reported outcomes
• Outcomes:
  Incidence of histologically confirmed NRH within the first 12 months of the study, Incidence of ADRs,SAEs,signs of liver toxicity/clinically relevant changes in lab data, clinical signs of NRH/non-cirrhotic portal hypertensionClinically relevant abnormalities in blood countTotal duration of 6-TG treatmentProportion of pts in remission at various treatment durationsInd. changes from baseline of HBI,SCCAI at various time points% terminating due to surgery,time to surgery
• Data analysis plan:
  Safety analysis data set contains all subjects who received 6-TG and have at least one record entry in the database. For quantitative parameters, descriptive statistics will be presented, i.e. mean, median, standard deviation, minimum and maximum. These statistics can relate to observed values, always including LOCF (last observation carried forward) endpoint visit, as well as to changes from baseline, including changes from baseline to each visit and LOCF endpoint.