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Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition

NCT02682381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2021-06-09

Study results available
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Summary

Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or to participate in a standard-of-care arm. All participants who complete the study may be eligible to receive the study drug in a long-term extension study.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Teduglutide 0.05mg/kg

0.05 mg/kg

DRUG

Teduglutide 0.025 mg/kg

0.025 mg/kg

OTHER

Standard of Care

Observational cohort for the 24-week treatment period and 4 week follow-up.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-23
Primary Completion
2017-08-18
Completion
2017-08-18

Countries

  • United States
  • Belgium
  • Canada
  • Finland
  • Germany
  • 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 NCT02682381 on ClinicalTrials.gov