Clinical Trial: A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
Brief Summary: 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.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Shire
Dates:
Date Received: November 11, 2013
Date Started: June 2014
Date Completion: December 2029
Last Updated: January 5, 2017
Last Verified: January 2017