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

• 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 efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.

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

Details

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

Criteria

Inclusion Criteria:

Participants who meet all of the following criteria will be enrolled in this 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.