An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

Phase 3

Completed

• Conditions: Short Bowel Syndrome (SBS)

• Registration Number: JPRN-jRCT2080223972
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

ong-term treatment with teduglutide produced sustained clinically meaningful reductions in PS requirements.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-06
• Study Completion: 2022-01-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Subjects who met all of the following criteria were eligible for inclusion in the study:
1.Ability to voluntarily provide written, signed, and informed consent to participate in the study.
2.Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4.
3.Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol.
4.An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Exclusion Criteria

There are no exclusion criteria for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified