Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Shire

Status and phase: Completed; Phase 3

Conditions: Short Bowel Syndrome

Treatments: Other: SOC; Drug: Teduglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02949362

2016-000863-17 (EudraCT Number)

SHP633-303

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm).
3. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Standard of Care (SOC) Treatment +/- Teduglutide

Experimental group

Description:

TED 0.05mg/kg subcutaneous injections once daily as needed in addition to SOC treatment

Treatment:

Drug: Teduglutide

Other: SOC