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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49834
• 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 Surveillance Epidemiology and End Results (SEER) incidence rates for US patients and for European and other populations to local cancer data sources, when available (ie, World Health Organization WHO GLOBOCAN). The secondary objective of this registry is to evaluate long-term outcomes in patients with SBS.
• Study status:
  Ongoing

Research institutions and networks

Institutions

NPS Pharmaceuticals Inc.

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

Shire

Study protocol

Initial protocol

TED-R13-002_Protocol_V2 0_11March2014_redacted.pdf

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