Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT01560403
Status:
COMPLETED
Last Update Posted:
2021-06-10
First Post:
2012-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
Sponsor:
Shire
Organization:
Study Overview
Official Title:
A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEPS3
Brief Summary:
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
Detailed Description:
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: