Teduglutide

Generic Name
Teduglutide
Brand Names
Gattex, Revestive
Drug Type
Biotech
Chemical Formula
-
CAS Number
197922-42-2
Unique Ingredient Identifier
7M19191IKG
Background

Teduglutide is a glucagon-like peptide-2 (GLP-2) analogue. It is made up of 33 amino acids and is manufactured using a strain of Escherichia coli modified by recombinant DNA technology. Teduglutide differs from GLP-2 by one amino acid (alanine is substituted by glycine). The significance of this substitution is that teduglutide is longer acting than endogeno...

Indication

Teduglutide is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Associated Conditions
Short Bowel Syndrome (SBS)
Associated Therapies
-

Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

First Posted Date
2018-09-10
Last Posted Date
2020-08-04
Lead Sponsor
Shire
Target Recruit Count
7
Registration Number
NCT03663582
Locations
🇯🇵

Hyogo College of Medicine Hospital, Hyogo, Japan

🇯🇵

Yokohama Municipal Citizen's Hospital, Yokohama, Japan

🇯🇵

Osaka University Hospital, Osaka, Japan

and more 2 locations

An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

First Posted Date
2018-07-23
Last Posted Date
2023-03-15
Lead Sponsor
Takeda
Target Recruit Count
11
Registration Number
NCT03596164
Locations
🇯🇵

Tohoku University Hospital, Miyagi-Ken, Japan

🇯🇵

Osaka University Hospital, Osaka, Japan

🇯🇵

Hyogo College of Medicine Hospital, Hyogo, Japan

and more 2 locations

Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome

First Posted Date
2018-06-27
Last Posted Date
2021-05-11
Lead Sponsor
Shire
Target Recruit Count
10
Registration Number
NCT03571516
Locations
🇬🇧

Royal Manchester Children's Hospital, Manchester, Greater Manchester, United Kingdom

🇫🇷

Groupe Hospitalier Pellegrin - Hôpital des Enfants, Bordeaux, Gironde, France

🇫🇷

Hopital Jeanne de Flandre - CHRU Lille, Lille, Nord, France

and more 5 locations

Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients

Phase 4
Completed
Conditions
Interventions
First Posted Date
2018-06-19
Last Posted Date
2020-12-04
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
25
Registration Number
NCT03562130
Locations
🇫🇷

Hôpital Necker - Enfants malades, Paris, France

Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-02-22
Last Posted Date
2022-05-25
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
21
Registration Number
NCT03442972
Locations
🇨🇦

Kensington Screening Clinic, Toronto, Ontario, Canada

🇨🇦

Toronto General Hopital, Toronto, Ontario, Canada

Plasma Lipoprotein Response to Glucagon-like Peptide-2

Phase 2
Completed
Conditions
Interventions
First Posted Date
2018-02-06
Last Posted Date
2022-06-14
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
10
Registration Number
NCT03422666
Locations
🇨🇦

Toronto General Hopital, Toronto, Ontario, Canada

A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-08-31
Last Posted Date
2022-05-24
Lead Sponsor
Shire
Target Recruit Count
9
Registration Number
NCT03268811
Locations
🇯🇵

Kagoshima University Hospital, Kagoshima, Kagoshima-Ken, Japan

🇯🇵

Showa University Hospital, Shinagawa-ku, Tokyo-To, Japan

🇯🇵

Akita University Hospital, Akita-shi, Akita-ken, Japan

and more 3 locations

Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-12-02
Last Posted Date
2022-02-02
Lead Sponsor
Shire
Target Recruit Count
10
Registration Number
NCT02980666
Locations
🇯🇵

Tsukuba University Hospital, Tsukuba, Ibaraki-Ken, Japan

🇯🇵

Kyushu University Hospital, Fukuoka-shi, Fukuoka-ken, Japan

🇯🇵

Kagoshima University, Kagoshima-shi, Kagoshima-Ken, Japan

and more 2 locations

Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Phase 3
Completed
Conditions
Interventions
First Posted Date
2016-10-31
Last Posted Date
2021-06-14
Lead Sponsor
Shire
Target Recruit Count
29
Registration Number
NCT02949362
Locations
🇺🇸

Mattel Children's Hospital UCLA, Los Angeles, California, United States

🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

🇺🇸

Riley Hospital for Children, Indianapolis, Indiana, United States

and more 8 locations

Teduglutide for Enterocutaneous Fistula (ECF)

First Posted Date
2016-09-05
Last Posted Date
2021-10-06
Lead Sponsor
Daniel Dante Yeh
Target Recruit Count
6
Registration Number
NCT02889393
Locations
🇺🇸

University of Miami, Miami, Florida, United States

© Copyright 2024. All Rights Reserved by MedPath