Ignite Creation Date:
2024-05-05 @ 9:40 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00930644
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2009-06-26
Brief Title:
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome SBS
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Long-Term Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2021-06
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:
None
Brief Summary:
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020
Detailed Description:
Some people with SBS need to infuse parenteral nutrition PN in order to live Although PN can save lives it can lead to some serious side effects such as infection or liver damage The risk for those effects increases the longer people are on PN
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS Teduglutide is similar to a protein the body makes When people have SBS their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks We also want to find out how safe teduglutide is and record any side effects
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS Teduglutide is similar to a protein the body makes When people have SBS their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks We also want to find out how safe teduglutide is and record any side effects
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-011679-65 | EUDRACT_NUMBER | None | None |