A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302

Shire

Status and phase: Completed; Phase 3

Conditions: Short Bowel Syndrome

Treatments: Drug: Teduglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03268811

SHP633-305

2021-005404-36 (EudraCT Number)

Details and patient eligibility

About

The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent by a parent or guardian prior to any study-related procedures.
• When applicable, informed assent (as deemed appropriate by the Institutional Review Board [IRB]) by the participant prior to any study-related procedures.
• Participant completed Study SHP633-302 (NCT02980666).
• Participant (and/or parent/guardian) 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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9 participants in 1 patient group

Teduglutide

Experimental group

Description:

Participants will receive teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24-week intervals. If a participant deteriorates during a follow-up period, the participant may be evaluated immediately for additional teduglutide treatment (24-week interval) until teduglutide is commercially available for each participant, the participant's participation in this study is discontinued, or the study is discontinued.

Treatment:

Drug: Teduglutide