drugset / Trial / NCT00930644
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2009-09-21
- Primary completion
- 2013-01-24
- Completion
- 2013-01-24
Publications
- Background 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.
- 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. Ther Adv Gastroenterol. 2020 Apr 20;13:1756284820905766. doi: 10.1177/1756284820905766. eCollection 2020.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Teduglutide | Peptide | 0.05 mg/kg | Subcutaneous |