Primary outcomeNumber· 12 months
Summary of Treatment-emergent Adverse Events
| Group | Value (participants) |
|---|---|
| NT,PBO/TED | 4 |
| TED/TED | 5 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
Short name STEPS3
NCTNCT01560403 (opens ClinicalTrials.gov in a new tab)Other idTED-C11-001
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 14 participants (actual)
- Sponsor
- Shire · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 21 May 2012
- Primary completion
- 23 Jul 2013
- Completion
- 23 Jul 2013
- First posted
- 22 Mar 2012 (estimated)
- Last update posted
- 10 Jun 2021
- Conditions
- Short Bowel Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- TeduglutideDrug
Arms1
Experimental
Teduglutide
0.05 mg/kg/day
Primary outcomes1
Outcomes the sponsor listed as primary.
Summary of Treatment-emergent Adverse Events
Time frame · 12 months
Registry description
As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| NT/PBO,TEDThis group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly | – | 1 / 9 | 4 / 9 |
| TED/TEDThis group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644) | – | 5 / 5 | 4 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2018
9 results
Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study.
Seidner et al. 2018Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutritioncited by 66
PMID 29761915DOI 10.1002/ncp.10092PUB-29761915
Full text at the publisher9 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:
1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed
Exclusion Criteria:
* None
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