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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 : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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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

Detailed Description:
28-MAY-2021: Enrollment of new Teduglutide treated adult participants into this study continues according to discretion and availability of sites during the COVID-19 situation, however, enrollment of untreated adult participants and pediatrics patients was stopped on the 30th April 2021 as the targets in these cohorts had been met. Enrollment of new Teduglutide treated adult participants is expected to be prolonged until 2022.
Study Design
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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, 2031
Estimated Study Completion Date : May 31, 2031

Resource links provided by the National Library of Medicine


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


Outcome Measures
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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. 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. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product (ICH Guidance E2A 1995). This includes an exacerbation of a pre-existing condition.

  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.


Eligibility Criteria
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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 adult 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 at the time of enrollment.

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.
  3. Participants who are currently or previously exposed to any Glucagon-like peptide 2 (GLP-2) analogs other than teduglutide.
Contacts and Locations
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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
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Contact: Shire Contact 1 866-842-5335 clinicaltransparency@shire.com

Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire
More Information
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Additional Information:

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01990040    
Other Study ID Numbers: TED-R13-002
EUPAS7973 ( Other Identifier: ENCePP EU PAS )
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda ( Shire ):
Short Bowel Syndrome
SBS
teduglutide
Gattex
Additional relevant MeSH terms:
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Short Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications