Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
- Registration Number
- NCT00930644
- Lead Sponsor
- Shire
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- must have completed 24 weeks of dosing of the CL0600-020 study
- none
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description teduglutide teduglutide 0.05 mg/kg/day
- Primary Outcome Measures
Name Time Method Percent Change in PN/IV Volume by Visit 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 24 months The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
- Secondary Outcome Measures
Name Time Method Number of Subjects Achieving PN/IV Reduction 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (23)
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej
🇵🇱Lublin, Poland
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
University of Pennslyvania
🇺🇸Philadelphia, Pennsylvania, United States
University Health Network - Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
University Of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Rigshospitalet
🇩🇰København, Denmark
Med. Klinik m.S. Hepatologie und Gastroenterologie
🇩🇪Berlin, BE, Germany
Hôpital Beaujon
🇫🇷Clichy, France
Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego
🇵🇱Lodz, Poland
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP
🇵🇱Warsaw, Poland
University College London Hospital
🇬🇧London, United Kingdom
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
St. Marks Hospital
🇬🇧Harrow, United Kingdom
Universitaetsklinikum Tuebingen Medizinische Klinik I
🇩🇪Tuebingen, BW, Germany
Scripps Clinic & Research Foundation
🇺🇸La Jolla, California, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Azienda Universitaria Policlinico Federico II
🇮🇹Napoli, Italy
Pracownia Żywienia Klinicznego
🇵🇱Olsztyn, Poland
Hopital de l'Archet 2
🇫🇷Nice, France
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada