Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

Shire

Status and phase: Completed; Phase 3

Conditions: Short Bowel Syndrome

Treatments: Other: SOC; Drug: TED; Device: Syringe; Device: Needle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02954458

2016-000849-30 (EudraCT Number)

SHP633-304

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. 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.
3. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Standard of care (SOC) treatment +/- teduglutide (TED)

Experimental group

Description:

Participants will receive 0.05 milligram per kilogram (mg/kg) of teduglutide subcutaneous (SC) injections once daily into 1 of the 4 quadrants of the abdomen or into either the thigh or arm as needed in addition to SOC treatment.

Treatment:

Device: Needle

Device: Syringe

Other: SOC

Drug: TED