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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01990040
First received: November 11, 2013
Last updated: March 17, 2016
Last verified: March 2016
  Purpose
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.

Condition
Short Bowel Syndrome

Study Type: Observational [Patient Registry]
Study Design: Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1310
Study Start Date: June 2014
Estimated Study Completion Date: December 2029
Estimated Primary Completion Date: December 2028 (Final data collection date for primary outcome measure)
Groups/Cohorts
Teduglutide treated
- SBS patients who have been treated with teduglutide
Non-teduglutide treated
- SBS patients who have not been treated with teduglutide

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This registry is to enroll both male and female patients, of any age, with a diagnosis of SBS.
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990040

Contacts
Contact: NPS Clinical Operations 908-450-5300

  Show 37 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Nicole Robichaud NPS Pharma
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01990040     History of Changes
Other Study ID Numbers: TED-R13-002 
Study First Received: November 11, 2013
Last Updated: March 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Short Bowel Syndrome
SBS
teduglutide
Gattex

Additional relevant MeSH terms:
Short Bowel Syndrome
Syndrome
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on May 03, 2016