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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-23

Study Completion Date

2021-11-02

Brief Summary

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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).

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Detailed Description

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Conditions

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Short Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teduglutide

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.

Group Type EXPERIMENTAL

Teduglutide

Intervention Type DRUG

Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.

Interventions

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Teduglutide

Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No