Summary
This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.
Conditions
Short Bowel Syndrome
Recruitment Status
COMPLETED
Eligibility Criteria
Inclusion Criteria:
1. Participant provides written informed consent (participant, parent or legal guardian and, as appropriate, informed assent) to participate in the study before completing any study-related procedures.
2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in the standard of care treatment arms). Participants are considered to have completed SHP633-301 if they completed study assessments through week 24.
3. Participant understands and is willing and able to fully adhere to study requirements as defined in this protocol.
Exclusion Criteria:
1. There are no exclusion criteria for this study.
Intervention
Intervention Type
Intervention Name
DRUG
TED
OTHER
SOC
DEVICE
Syringe
DEVICE
Needle
Phase
PHASE3
Gender
ALL
Min Age
N/A
Max Age
N/A
Download Date
2021-10-13
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: