Summary
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.
Conditions
Short Bowel Syndrome
Recruitment Status
Completed
Eligibility Criteria
Inclusion Criteria:
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.
Subject completed the TED-C13-003 study (including subjects in the standard of care treatment arm).
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.
Intervention
Intervention Type
Intervention Name
Drug
Teduglutide
Other
SOC
Phase
Phase 3
Gender
All
Min Age
N/A
Max Age
N/A
Download Date
June 14, 2021
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: