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

Status: Active, not recruiting
Location: See location...
Study Type: Observational [Patient Registry]
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: No
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: June 23, 2014
Estimated Completion Date: April 30, 2033
Participants
Target number of participants: 1800
Treatments
Teduglutide treated
SBS participants who have been treated with teduglutide.
Non-teduglutide treated
SBS participants who have not been treated with teduglutide.
Authors
Emmanuelle Ressiot-Gerolami, Amar Desphande, Anuparna Chawla, Dong-Wook Kim, Dawn Adams, Susan Galandiuk, Syed Mohammed Jafri, Lei Yu, Maria Segovia, Lauren Schwartz, Robert Carroll, Thomas Ziegler, Guillermo Somodevilla, Mark Reichelderfer, Douglas Farmer, Adam Brinkman, Blanca Gonzalez, Lee Cummings, Satinder Gill, Vijay Yajnik, Reed Dimmitt, Herschel Vargas, Shilpa Ravella, Millie Long, Ece Mutlu, Marcus Muehlbauer, Ramon Berenguer, Michael Rothkopf, Cheng Zhang, Mark Corkins, Kishore Iyer, Madalina Butnariu, Beth Carter, Keith Obstein, Joel Mason, Esperanza Arce-Nunez, Vladimir Santos, Trevor Smith, Sarah Glover, David Binion, Jennifer Garcia, Joshua Korzenik, Simon Horslen, Joseph Pisegna, John Monson, Sue Rhee, Karukurichi Venkatesh, Debra Sudan, Russell Merritt, John Thompson, Jorge Vazquez, Sukanya Subramanian, Patricia Byers, David Mercer, Gabriel Gondolesi, David Stump, Andrew DuPont, Charles Vanderpool, David Galloway, Shirley Paski, Jaime Mayoral, Gary Matusow, Douglas Seidner, David Neumann, Hanne Farstad, Esther Ramos Boluda, Jan Lillienau, Svein-Oskar Frigstad, Raquel Nuñez Ramos, Silvia Mauri, Andre Hoerning, Suzanne Donnelly, Jan De Laffolie, Frederic Gottrand, Gunter Flemming, Estelle Becam, Cloe Charpentier, Beatrice Dubern, Florian Poullenot, Yurdaguel Zopf, Cécile Chambrier, Sabrina Layec, Jan Wehkamp, Irina Blumenstein, Sibylle Koletzko, Laura Armengol-Debeir, Susan Protheroe, Thomas Ochsenkuehn, Ulrike Zech, David Seguy, Noël Peretti, Ronan Thibault, Stéphane Schneider, Hans-Georg Lamprecht, Anne Breton, Ingolf Schiefke, Ulrike von Arnim, Didier Quilliot, Olivier Goulet, Farooq Rahman, Eric Fontaine, Kristin Van Buren, Peter Nichol, David Andersson, Ulf Prestegaard, Nicolas Flori, Marine Barraud Blanc, Antonella De Francesco, Marie-Édith Coste-Tramini, Francesco Guglielmi, Rosa Burgos, Stephan Gehring, Simon Gabe, Susan Hill, Francisca Joly, Greger Lindberg, Palle Jeppesen, Carmina Wanden-Berghe, Birgitte Seip, Loris Pironi, Lars Vinter-Jensen, Simon Lal, Petr Ricanek, Ulrich-Frank Pape, Elisabeth Bluethner, Cristina de la Cuerda Compes, Maria Nuria Nuria Virgili Casas, Mikko Pakarinen, Ashish Saharia, Jean-Pierre Hugot, Johane Allard, Fabrizio Pasanisi, Ashwin Ananthakrishnan, Hartmut Schmidt, Sherilyn Gordon Burroughs
Related Therapeutic Areas
Sponsors
Collaborators: Takeda Development Center Americas, Inc.
Leads: Shire

This content was sourced from clinicaltrials.gov