Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172185
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2005-09-13
Brief Title:
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 NCT00081458
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 NCT00081458
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:
None
Brief Summary:
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide
Detailed Description:
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 GLP-2 a peptide secreted by L-cells of the distal intestine GLP-2 is known to increase intestinal and portal blood flow and inhibit gastric acid secretion Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor IGF-1 nitric oxide and keratinocyte growth factor KGF
This multicenter double-blind international Phase III trial will have a treatment period of 28 weeks Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 NCT00081458 These subjects will receive daily subcutaneous injections of 005 milligrams or 010 milligrams of teduglutide per kilogram of body weight Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition PN reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol or do not enter into the long-term safety extension protocol CL0600-010
This multicenter double-blind international Phase III trial will have a treatment period of 28 weeks Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 NCT00081458 These subjects will receive daily subcutaneous injections of 005 milligrams or 010 milligrams of teduglutide per kilogram of body weight Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition PN reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol or do not enter into the long-term safety extension protocol CL0600-010
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 |
|---|---|---|---|
| 2004-000439-27 | EUDRACT_NUMBER | None | None |