Phase 3
Completed N=14
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
Short Bowel Syndrome
Source: ClinicalTrials.gov NCT01560403 ↗
Enrolled (actual)
14
Serious AEs
42.9%
Results posted
Dec 2014
Primary outcomePrimary: Summary of Treatment-emergent Adverse Events — 4; 5 participants
Summary
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Treatment-emergent Adverse Events |
4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:
- Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
- Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01560403). 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.