A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome

Status: Active_not_recruiting
Location: See location...
Study Type: Observational
SUMMARY

This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS).

• Signed informed consent and medical records release by the participant or a legally acceptable representative

• Participants who have never received teduglutide treatment must be on parenteral nutrition (PN)/intravenous (IV) fluids support for at least 6 months at the time of enrollment.

Locations
United States
Massachusetts
Shire
Lexington
Time Frame
Start Date: 2014-06-23
Completion Date: 2032-06-30
Participants
Target number of participants: 1806
Treatments
Teduglutide treated
SBS participants who have been treated with teduglutide.
Non-teduglutide treated
SBS participants who have not been treated with teduglutide.
Authors
Hanne Farstad, Dawn Adams, Lei Yu, Maria Segovia, Guillermo Somodevilla, Blanca Gonzalez, Mark Reichelderfer, Douglas Farmer, Adam Brinkman, Vijay Yajnik, Reed Dimmitt, Herschel Vargas, Michael Rothkopf, Ashish Saharia, David Neumann, Marcus Muehlbauer, Ramon Berenguer, Mark Corkins, Kishore Iyer, Madalina Butnariu, Beth Carter, Keith Obstein, Joel Mason, Esperanza Arce-Nunez, Peter Nichol, Vladimir Santos, Ashwin Ananthakrishnan, David Binion, Joshua Korzenik, Simon Horslen, John Monson, Sue Rhee, Karukurichi Venkatesh, Syed Mohammed Jafri, Debra Sudan, Russell Merritt, Jorge Vazquez, Patricia Byers, David Mercer, Gabriel Gondolesi, David Stump, Andrew DuPont, Charles Vanderpool, David Galloway, Shirley Paski, Jaime Mayoral, Gary Matusow, Andre Hoerning, Suzanne Donnelly, Jan De Laffolie, Frederic Gottrand, Gunter Flemming, Ulrich-Frank Pape, Cloe Charpentier, Beatrice Dubern, Florian Poullenot, Yurdaguel Zopf, Cécile Chambrier, Sabrina Layec, Jan Wehkamp, Irina Blumenstein, Sibylle Koletzko, Laura Armengol-Debeir, Ulrike Zech, David Seguy, Noël Peretti, Ronan Thibault, Stéphane Schneider, Ingolf Schiefke, Ulrike von Arnim, Didier Quilliot, Olivier Goulet, Trevor Smith, Farooq Rahman, Lee Cummings, Robert Carroll, Sukanya Subramanian, Millie Long, Satinder Gill, Shilpa Ravella, Ece Mutlu, Thomas Ziegler, Joseph Pisegna, Sarah Glover, Carmina Wanden-Berghe, Greger Lindberg, Elisabeth Bluethner, Jean-Pierre Hugot, Hartmut Schmidt, Loris Pironi, Petr Ricanek, Simon Gabe, Francisca Joly, Palle Jeppesen, Johane Allard, Simon Lal, Fabrizio Pasanisi, Mikko Pakarinen
Related Therapeutic Areas
Sponsors
Collaborators: Takeda Development Center Americas, Inc.
Leads: Shire

This content was sourced from clinicaltrials.gov