Phase 3
Completed N=88
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
Short Bowel Syndrome
Source: ClinicalTrials.gov NCT00930644 ↗
Enrolled (actual)
88
Serious AEs
63.6%
Results posted
Dec 2014
Primary outcomePrimary: Percent Change in PN/IV Volume by Visit — -5.35; -6.44; -40.65; -12.88 percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in PN/IV Volume by Visit |
-5.35; -6.44; -40.65; -12.88; -10.27; -44.24 | — |
| PRIMARY Absolute Change in PN/IV Volume by Visit |
-1.05; -0.95; -5.28; -1.88; -1.38; -5.62 | — |
| SECONDARY Number of Subjects Achieving PN/IV Reduction |
3; 14; 21; 2; 7; 18 | — |
Eligibility Criteria
Inclusion Criteria
- must have completed 24 weeks of dosing of the CL0600-020 study
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT00930644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.