Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Short Bowel Syndrome Clinical Trial

Official title:

A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930644
• Other study ID #: CL0600-021
• Secondary ID: 2009-011679-65
• Status: Completed
• Phase: Phase 3
• Start date: September 21, 2009
• Est. completion date: January 24, 2013

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 24, 2013
• Est. primary completion date: January 24, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• must have completed 24 weeks of dosing of the CL0600-020 study

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 24 months

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
Denmark	Rigshospitalet	København
France	Hôpital Beaujon	Clichy
France	Hopital de l'Archet 2	Nice
Germany	Med. Klinik m.S. Hepatologie und Gastroenterologie	Berlin	BE
Germany	Universitaetsklinikum Tuebingen Medizinische Klinik I	Tuebingen	BW
Italy	Azienda Universitaria Policlinico Federico II	Napoli
Poland	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 Zywienia Klinicznego	Olsztyn
Poland	Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orlowskiego CMKP	Warsaw
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
United Kingdom	St. Marks Hospital	Harrow
United Kingdom	University College London Hospital	London
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Scripps Clinic & Research Foundation	La Jolla	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	University of Pennslyvania	Philadelphia	Pennsylvania
United States	University Of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Shire	Nycomed Germany GmbH

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in PN/IV Volume by Visit	The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.	24 months
Primary	Absolute Change in PN/IV Volume by Visit	The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.	24 months
Secondary	Number of Subjects Achieving PN/IV Reduction	The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.	24 Months or Last Dosing Visit