Status:
COMPLETED
A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302
Lead Sponsor:
Shire
Collaborating Sponsors:
Takeda
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Informed consent by a parent or guardian prior to any study-related procedures.
- When applicable, informed assent (as deemed appropriate by the Institutional Review Board \[IRB\]) by the participant prior to any study-related procedures.
- Participant completed Study SHP633-302 (NCT02980666).
- Participant (and/or parent/guardian) understands and is willing and able to fully adhere to study requirements as defined in this protocol.
Exclusion
- There are no exclusion criteria for this study.
Key Trial Info
Start Date :
August 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03268811
Start Date
August 23 2017
End Date
November 2 2021
Last Update
May 24 2022
Active Locations (6)
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1
Akita University Hospital
Akita, Akita, Japan, 010-8543
2
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
3
Tsukuba University Hospital
Tsukuba, Ibaraki, Japan, 305-8576
4
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan, 890-8520