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A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302

NCT03268811 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-05-24

Study results available
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Summary

The purpose of this clinical study is to evaluate the long-term safety and tolerability of teduglutide treatment in Japanese pediatric participants with short bowel syndrome (SBS) who completed Study SHP633-302 (NCT02980666).

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Teduglutide

Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • 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
2017-08-23
Primary Completion
2021-11-02
Completion
2021-11-02
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

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 NCT03268811 on ClinicalTrials.gov