Clinical trial NCT00930644: Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
Official title: A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Short Bowel Syndrome
Keywords: short bowel syndrome
parenteral nutrition
PN
HPN
TPN
SBS
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Nycomed Germany GmbH
First posted: 2009-06-30
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Percent Change in PN/IV Volume by Visit
timeFrame: 24 months
measure: Absolute Change in PN/IV Volume by Visit
timeFrame: 24 months
Secondary outcomes:
measure: Number of Subjects Achieving PN/IV Reduction
timeFrame: 24 Months or Last Dosing Visit
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic & Research Foundation
state: California
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennslyvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University Of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: København
country: Denmark
facility: Rigshospitalet
city: Clichy
country: France
facility: Hôpital Beaujon
city: Nice
country: France
facility: Hopital de l'Archet 2
city: Berlin
country: Germany
facility: Med. Klinik m.S. Hepatologie und Gastroenterologie
state: BE
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen Medizinische Klinik I
state: BW
city: Napoli
country: Italy
facility: Azienda Universitaria Policlinico Federico II
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej
city: Olsztyn
country: Poland
facility: Pracownia Żywienia Klinicznego
city: Warsaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Harrow
country: United Kingdom
facility: St. Marks Hospital
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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. Therap Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.