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Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome

NCT03571516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-05-11

Study results available
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Summary

The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Teduglutide

SC injection of 0.05 mg/kg teduglutide will be administered QD into abdomen or into either the thigh or arm for 24 weeks.

OTHER

Standard Medical Therapy

Standard medical therapy will be administered for 24 weeks.

DEVICE

Syringe

Teduglutide will be administered using syringe (510k number: K980987).

DEVICE

Needle

Teduglutide will be administered using needle (510k number: K021475).

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-09-24
Completion
2020-09-24
FDA Drug
Yes
FDA Device
Yes

Countries

  • Finland
  • France
  • 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 NCT03571516 on ClinicalTrials.gov