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CLINICAL TRIALS PROFILE FOR GATTEX KIT

All Clinical Trials for Gattex Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00072839 ↗	Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease	Completed	Shire	Phase 2	2003-11-12	The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.
NCT00081458 ↗	Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome	Completed	Shire	Phase 3	2004-05-25	The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).
NCT00172185 ↗	Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)	Completed	Shire	Phase 3	2005-01-10	The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
NCT00798967 ↗	Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects	Completed	Nycomed	Phase 3	2008-11-25	Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (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. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

Clinical Trial Conditions for Gattex Kit

Condition Name

Condition Name for Gattex Kit
Intervention	Trials
Short Bowel Syndrome	6
Ileostomy - Stoma	1
Pharmacokinetics and Safety of Elevated Doses	1
Postoperative Fistula	1

Condition MeSH

Condition MeSH for Gattex Kit
Intervention	Trials
Syndrome	6
Short Bowel Syndrome	6
Fistula	1
Inflammation	1

Clinical Trial Locations for Gattex Kit

Trials by Country

Trials by Country for Gattex Kit
Location	Trials
United States	57
Canada	13
Germany	6
United Kingdom	6
France	4

Trials by US State

Trials by US State for Gattex Kit
Location	Trials
Pennsylvania	6
New York	6
Ohio	5
Georgia	5
Florida	4

Clinical Trial Progress for Gattex Kit

Clinical Trial Phase

Clinical Trial Phase for Gattex Kit
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Gattex Kit
Clinical Trial Phase	Trials
Completed	11
Not yet recruiting	1

Clinical Trial Sponsors for Gattex Kit

Sponsor Name

Sponsor Name for Gattex Kit
Sponsor	Trials
Shire	9
Massachusetts General Hospital	2
Nycomed Germany GmbH	1

Sponsor Type

Sponsor Type for Gattex Kit
Sponsor	Trials
Industry	13
Other	7
NIH	2