Retrospective Study on Participants With Short Bowel Syndrome and Chronic Intestinal Failure That Underwent Transplantation in Brazil

NCT ID: NCT05113082

Last Updated: 2022-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-21

Study Completion Date

2022-10-15

Brief Summary

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The main aim of this study is to capture management and treatment outcome data in participants with short bowel syndrome and chronic intestinal failure (SBS-IF) that underwent intestinal transplantation in Brazil.

This study is about collecting data available in the participant's medical record and will also describe the demographic and clinical characteristics of these participants. No medication will be provided to participants in this study.

Clinical data will be collected from a period up to 10 years before the day of the intestinal transplantation. No clinic visits will be required as part of participation in this study.

Detailed Description

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Conditions

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Short Bowel Syndrome (SBS)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants with SBS-IF

Participants with SBS-IF who as part of standard or routine clinical practice, that underwent intestinal transplantation over the last 10 years (both dead and alive at the time of study enrollment) will be observed in this retrospective observational study for 10 months.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants with a diagnosis of SBS-IF, who underwent intestinal transplantation between April 2011 to April 2021.
* Participants who have signed the informed consent form (or his/her legal representative). For deceased participants or those with lost to follow-up, an informed consent form (ICF) waiver is acceptable.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, , Brazil

Site Status

Countries

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Brazil

Related Links

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https://clinicaltrials.takeda.com/study-detail/61bcf2e9f571d4002a64b4b3

To obtain more information on the study, click here/on this link

Other Identifiers

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TAK-633-4007

Identifier Type: -

Identifier Source: org_study_id

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