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A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older

NCT05027308 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-05-16

Study results available
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Summary

The main aims of the study are to check for side effects from teduglutide.

Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks. Participants may be able to repeat this treatment if they meet specific criteria. The study doctors will check for side effects from teduglutide until it becomes commercially available. The maximum duration of treatment is approximately 51.3 weeks.

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Teduglutide

Teduglutide 0.05 mg/kg SC injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2023-09-27
Completion
2023-09-27
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 NCT05027308 on ClinicalTrials.gov