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Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

NCT02954458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-03-28

Study results available
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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.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

TED

0.05 mg/kg SC injection once daily.

OTHER

SOC

Standard safety assessments and adjustments in nutritional support.

DEVICE

Syringe

Teduglutide will be administered using syringe.

DEVICE

Needle

Teduglutide will be administered using needle.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-09
Primary Completion
2020-11-05
Completion
2020-11-05
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Finland
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954458 on ClinicalTrials.gov