Phase 3
N=65
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
Short Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00172185 ↗Enrolled (actual)
65
Serious AEs
41.5%
Results posted
Apr 2013
Primary outcome: Primary: Number of Subjects Achieving a 20% Reduction at Week 28 — 5; 3; 17; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- teduglutide 0.05 mg/kg/d (Drug); teduglutide 0.10 mg/kg/d (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Achieving a 20% Reduction at Week 28 |
5; 3; 17; 14 | — |
| SECONDARY Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use |
4; 2; 17; 10; 2; 5 | — |
Summary
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Eligibility Criteria
Inclusion Criteria
At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.
Subjects who meet all of the following criteria can be enrolled in this study:
- Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
- Completion of protocol CL0600-004 (NCT00081458)
Exclusion Criteria
- History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
- History of alcohol or drug abuse (within previous year)
- Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
- Pregnant or lactating women
- Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
Data sourced from ClinicalTrials.gov (NCT00172185). 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.