Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Purpose

The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period. It will evaluate how these children fared after the TED-C13-003 study ended. This study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in TED-C13-003.

Condition

  • Short Bowel Syndrome

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject provides written informed consent (subject, parent or legal guardian and, as appropriate, subject informed assent) to participate in the study before completing any study-related procedures. 2. Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm). 3. Subject understands and is willing and able to fully adhere to study requirements as defined in this protocol.

Exclusion Criteria

There are no exclusion criteria for this study.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Standard of Care (SOC) Treatment +/- Teduglutide 		TED 0.05mg/kg subcutaneous injections once daily as needed in addition to SOC treatment
  • Drug: Teduglutide
    0.05mg/kg
  • Other: SOC
    Standard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods

More Details

Status
Completed
Sponsor
Shire

Study Contact