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A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01990040
First received: November 11, 2013
Last updated: May 9, 2016
Last verified: May 2016

November 11, 2013
May 9, 2016
June 2014
December 2028   (final data collection date for primary outcome measure)
Occurrence of colorectal cancer in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: At least 10 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01990040 on ClinicalTrials.gov Archive Site
  • Occurrence of other malignancy in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: At least 10 years ] [ Designated as safety issue: Yes ]
  • Actual volume change in parenteral support in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: At least 10 years ] [ Designated as safety issue: No ]
  • Occurrence of benign neoplasia of the gastrointestinal tract, hepatobiliary system, and pancreas in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Occurrence of colorectal polyps in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Occurrence of intestinal obstruction in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Occurrence of pancreatic and biliary disease in patients with short bowel syndrome who who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Occurrence of heart failure and other manifestations of volume overload in patients with short bowel syndrome who who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Occurrence of allergic/hypersensitivity reaction to teduglutide in patients with short bowel syndrome who who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Percentage volume change in parenteral support in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Occurrence of other long-term safety outcomes in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in patients with SBS. SBS patients treated and not treated with teduglutide will be enrolled.
Not Provided
Observational [Patient Registry]
Time Perspective: Prospective
10 Years
Not Provided
Non-Probability Sample
This registry is to enroll both male and female patients, of any age, with a diagnosis of SBS.
Short Bowel Syndrome
Not Provided
  • Teduglutide treated
    - SBS patients who have been treated with teduglutide
  • Non-teduglutide treated
    - SBS patients who have not been treated with teduglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1310
December 2029
December 2028   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male and female patients, of any age, with a diagnosis of SBS
  2. Signed informed consent and medical records release by the patient or a legally acceptable representative

Exclusion Criteria:

Both
Child, Adult, Senior
No
Contact: Shire Contact clinicaltransparency@shire.com
United States,   Denmark
 
NCT01990040
TED-R13-002
No
Not Provided
Not Provided
Shire
Shire
Not Provided
Study Director: Shire Study Physician Shire
Shire
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP