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Registry for Participants With Short Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT01990040
Recruitment Status : Recruiting
First Posted : November 21, 2013
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants 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 participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled.

Condition or disease
Short Bowel Syndrome

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1310 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
Actual Study Start Date : June 23, 2014
Estimated Primary Completion Date : May 31, 2029
Estimated Study Completion Date : May 31, 2029

Resource links provided by the National Library of Medicine


Group/Cohort
Teduglutide treated
SBS participants who have been treated with teduglutide.
Non-teduglutide treated
SBS participants who have not been treated with teduglutide.



Primary Outcome Measures :
  1. Occurrence of Colorectal Cancer in Short Bowel Syndrome (SBS) Participants With a Remnant Colon Currently Being Treated With or Ever Having Been Treated With Teduglutide [ Time Frame: 10 years ]
    Incidence rates of colorectal cancer in participants will be calculated by dividing the number of incident colorectal cancer cases by the total number of person-years observed since beginning treatment with teduglutide.


Secondary Outcome Measures :
  1. Occurrence of Other Malignancy [ Time Frame: 10 years ]
    Incidence rates of other malignancies will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  2. Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants [ Time Frame: 10 years ]
    Incidence rates of benign neoplasia of the GI tract, hepatobiliary system, and pancreas will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  3. Occurrence of Colorectal Polyps [ Time Frame: 10 years ]
    Incidence rates of colorectal polyps will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  4. Occurrence of Intestinal Obstruction [ Time Frame: 10 years ]
    Incidence rates of intestinal obstruction will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  5. Occurrence of Pancreatic and Biliary Disease [ Time Frame: 10 years ]
    Incidence rates of pancreatic and biliary disease will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  6. Occurrence of Heart Failure and Other Manifestations of Volume Overload [ Time Frame: 10 years ]
    Incidence rates of heart failure and other manifestations of volume overload will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  7. Occurrence of Allergic/Hypersensitivity Reaction to Teduglutide [ Time Frame: 10 years ]
    Incidence rates of allergic/hypersensitivity reactions to teduglutide will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  8. Occurrence of Other Adverse Events (AEs) Potentially Related to Treatment with Teduglutide [ Time Frame: 10 years ]
    Incidence rates of other AEs will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide.

  9. Actual Volume Change in Parenteral Support (PS) [ Time Frame: 10 years ]
    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

  10. Percentage Volume Change in Parenteral Support (PS) [ Time Frame: 10 years ]
    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

  11. Actual Change in the Number of Days per Week on Parenteral Support (PS) [ Time Frame: 10 years ]
    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

  12. Percentage Change in the Number of Days per Week on Parenteral Support (PS) [ Time Frame: 10 years ]
    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

  13. Percent of Participants Weaning From Parental Support (PS) [ Time Frame: 10 years ]
    PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.



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Ages Eligible for Study:   Child, Adult, Older Adult
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 participants, of any age, with a diagnosis of SBS.
Criteria

Inclusion Criteria:

  1. Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS).
  2. Signed informed consent and medical records release by the participant or a legally acceptable representative
  3. Participants who have never received teduglutide treatment must be on parenteral nutrition (PN)/intravenous (IV) fluids support for at least 6 months.

Exclusion criteria:

  1. Participants currently participating in a blinded clinical trial or their extension studies.
  2. Participants who have never been on PN/IV support.

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 1 866-842-5335 clinicaltransparency@shire.com

  Show 61 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Study Director Shire

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01990040     History of Changes
Other Study ID Numbers: TED-R13-002
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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