TED-R13-002: A Prospective, Multi-center Registry for Patients with Short Bowel Syndrome (TED-R13-002: SBS Registry)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational Registry

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A16AX08) teduglutide

  teduglutide
• Medical condition to be studied:
  Short-bowel syndrome

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  1806

Study design details

• Main study objective:
  To evaluate the long-term safety profile for patients with SBS who are treated with teduglutide in a routine clinical setting. ; The primary safety outcome is the occurrence of colorectal cancer in SBS patients with any remnant colon currently being treated or ever having been treated with teduglutide.
• Outcomes:
  Occurrence of colorectal cancer in patients with SBS with any remnant colon currently being treated with or ever having been treated with teduglutide. ; Occurrence of: Other malignancy, Benign neoplasia of GI tract, hepatobiliary system, and pancreas, Colorectal polyps, Intestinal obstruction, Pancreatic and biliary disease, Heart failure/other manifestations of volume overload, Allergic/hypersensitivity reaction to teduglutide, Other adverse events potentially related to treatment with teduglutide, Change in parenteral support.
• Data analysis plan:
  Detailed statistical analysis methods will be conducted as described in the SAP for this study. ; Data will be summarized with tabulated descriptive statistics: number of observations, minimum, maximum, mean, median, standard deviation, and range for continuous variables and counts and percentages for categorical variables. ; In addition, graphical data displays will be used to summarize selected data. ; Person-years of follow-up and incidence rates of selected prospective events will be calculated.