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

This study is currently recruiting participants.
Verified January 2017 by Shire
Sponsor:
ClinicalTrials.gov Identifier:
NCT01990040
First Posted: November 21, 2013
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
November 11, 2013
November 21, 2013
January 6, 2017
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 ]
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 ]
  • 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 ]
  • 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 ]
  • Occurrence of colorectal polyps in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ]
  • Occurrence of intestinal obstruction in patients with short bowel syndrome who are treated with teduglutide in a routine clinical setting [ Time Frame: 10 years ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
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
 
Recruiting
1310
December 2029
December 2028   (Final data collection date for primary outcome measure)
This is an observational registry study. Data will be collected during routine consultations and clinical staff will enter this information into a system at baseline (when a patient consents into the study) and approximately every 6 months following. Each patient will be followed for at least 10 years.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact: Shire Contact clinicaltransparency@shire.com
Canada,   Denmark,   France,   Germany,   Norway,   United Kingdom,   United States
 
 
NCT01990040
TED-R13-002
No
Not Provided
Not Provided
Shire
Shire
Not Provided
Study Director: Shire Study Physician Shire
Shire
January 2017