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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
  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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990040


Contacts
Contact: Shire Contact clinicaltransparency@shire.com

  Show 61 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Study Physician Shire
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01990040     History of Changes
Other Study ID Numbers: TED-R13-002
First Submitted: November 11, 2013
First Posted: November 21, 2013
Last Update Posted: January 6, 2017
Last Verified: January 2017

Keywords provided by Shire:
Short Bowel Syndrome
SBS
teduglutide
Gattex

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