Summary

at San Francisco, California and other locations
study started
estimated completion:
Sue Rhee

Description

Summary

This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.

Official Title

A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301

Keywords

Short Bowel Syndrome Syndrome TED SOC Syringe Needle

Eligibility

You can join if…

  1. Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
  2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.
  3. Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.

You CAN'T join if...

  1. There are no exclusion criteria for this study.

Locations

  • UCSF Benioff Children's Hospital
    San Francisco California 94158-2531 United States
  • Childrens Hospital Los Angeles - RHU
    Los Angeles California 90027-6062 United States
  • Mattel Children's Hospital UCLA
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shire
ID
NCT02954458
Phase
Phase 3
Lead Scientist
Sue Rhee
Study Type
Interventional
Last Updated
June 27, 2018