DRUG
teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 24 months
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
Status
Completed
Phase
Phase 3
Enrollment
88
Locations
23
Results
Posted
Publications
2
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 30, 2009
Study start
Sep 21, 2009
Primary completion
Jan 24, 2013
Study completion
Jan 24, 2013
Results posted
Dec 24, 2014
Registry updated
Jun 11, 2021
Outcomes
What the study measures.
Primary outcomes
Percent Change in PN/IV Volume by Visit
Time frame · 24 months
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Absolute Change in PN/IV Volume by Visit
Time frame · 24 months
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
Secondary outcomes
Number of Subjects Achieving PN/IV Reduction
Time frame · 24 Months or Last Dosing Visit
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * must have completed 24 weeks of dosing of the CL0600-020 study Exclusion Criteria: * none
Study locations
23 registered sites.
Canada · Denmark · France · Germany · Italy · Poland · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Scripps Clinic & Research Foundation
La Jolla, California, United States
Mount Sinai Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Royal Alexandra Hospital
Edmonton, Alberta, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Rigshospitalet
Copenhagen, Denmark
Hôpital Beaujon
Clichy, France
Hopital de l'Archet 2
Nice, France
Universitaetsklinikum Tuebingen Medizinische Klinik I
Tübingen, Baden-Wurttemberg, Germany
Med. Klinik m.S. Hepatologie und Gastroenterologie
Berlin, State of Berlin, Germany
Azienda Universitaria Policlinico Federico II
Naples, Italy
Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego
Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej
Lublin, Poland
Pracownia Żywienia Klinicznego
Olsztyn, Poland
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
Warsaw, Poland
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
St. Marks Hospital
Harrow, United Kingdom
University College London Hospital
London, United Kingdom
Publications
Results and literature.
PMID 16099790 ↗Jeppesen PB, Sanguinetti EL, Buchman A, Howard L, Scolapio JS, Ziegler TR, Gregory J, Tappenden KA, Holst J, Mortensen PB. Teduglutide (ALX-0600), a dipeptidyl peptidase IV resistant glucagon-like peptide 2 analogue, improves intestinal function in short bowel syndrome patients. Gut. 2005 Sep;54(9):1224-31. doi: 10.1136/gut.2004.061440.PMID 32341691 ↗Pape UF, Iyer KR, Jeppesen PB, Kunecki M, Pironi L, Schneider SM, Seidner DL, Lee HM, Caminis J. Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials. Ther Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.
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More studies on Teduglutide.
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Related PeptideStat pages
Put the record in context.
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