Current Environment:

Summary

This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.

Conditions

Short Bowel Syndrome

Recruitment Status

Completed

Eligibility Criteria

Inclusion Criteria:

Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.
Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion Criteria:

1. There are no exclusion criteria for this study.

Intervention

Intervention Type

Intervention Name

Drug

TED

Other

SOC

Device

Syringe

Device

Needle

Phase

Phase 3

Gender

All

Minimum Age

N/A

Maximum Age

N/A

Download Date

October 13, 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: