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

Study identification

• EU PAS number:
  EUPAS7973
• Study ID:
  49834
• Official title and acronym:
  TED-R13-002: A Prospective, Multi-center Registry for Patients with Short Bowel Syndrome (TED-R13-002: SBS Registry)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Canada

  Croatia

  Czechia

  Denmark

  Finland

  France

  Germany

  Italy

  Norway

  Slovenia

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  This is a single-group, prospective, observational, multi-center (ie, world-wide) registry designed to collect data on long-term safety and clinical outcomes in Short Bowel Syndrome (SBS) patients. ; This registry permits interested SBS patients and SBS-treating health care providers to participate. Patients exposed and not exposed to teduglutide will be recruited. A select set of data will be collected at baseline, and as available, every 6 months (i.e., 2 times a year). ; This study is planned for 5 years of enrollment with at least 10 years of follow-up for each SBS patient. ; The primary objective of this registry is 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 with or ever having been treated with teduglutide. ; The overall observed incidence of colorectal cancer for teduglutide-treated patients with any remnant colon will be compared with the incidence of colorectal cancer in the latest available US and global cancer data sources (for example, population-based registries, healthcare claims databases, or federated electronic health record networks with validated oncology outcomes). ; The secondary objective of this registry is to evaluate long-term outcomes in patients with SBS.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Actual: 22/10/2013

Study start date

Actual: 23/06/2014

Date of final study report

Planned: 30/04/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)

Other study registration identification numbers and links

NCT01990040 https://clinicaltrials.gov/ct2/show/NCT01990040?term=NCT01990040&rank=1