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Summary

The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period. It will evaluate how these children fared after the TED-C13-003 study ended. This study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in TED-C13-003.

Conditions

Short Bowel Syndrome

Recruitment Status

Completed

Eligibility Criteria

Inclusion Criteria:

Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, subject informed assent) to participate in the study before completing any study-related procedures.
Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm).
Subject understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion Criteria:

There are no exclusion criteria for this study.

Intervention

Intervention Type

Intervention Name

Drug

Teduglutide

Other

SOC

Phase

Phase 3

Gender

All

Min Age

N/A

Max Age

N/A

Download Date

June 14, 2021

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: