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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Collaborator: Takeda
• Treatments: Teduglutide

Criteria

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.