A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
STEPS3
1 other identifier
interventional
14
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2012
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedStudy Start
First participant enrolled
May 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2013
CompletedResults Posted
Study results publicly available
December 25, 2014
CompletedJune 10, 2021
May 1, 2021
1.2 years
March 13, 2012
December 16, 2014
May 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summary of Treatment-emergent Adverse Events
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.
12 months
Study Arms (1)
Teduglutide
EXPERIMENTAL0.05 mg/kg/day
Interventions
0.05 mg/kg/day subcutaneously taken once per day for 12 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (5)
Scripps Clinic & Research Foundation
La Jolla, California, 92037, United States
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (1)
Seidner DL, Fujioka K, Boullata JI, Iyer K, Lee HM, Ziegler TR. 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. Nutr Clin Pract. 2018 Aug;33(4):520-527. doi: 10.1002/ncp.10092. Epub 2018 May 15.
PMID: 29761915RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study provided further long-term safety and efficacy data on the 14 US subjects who enrolled in the CL0600-020 and the CL0600-021 study. Given the small number of subjects in this study, only descriptive statistics were employed and presented.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2012
First Posted
March 22, 2012
Study Start
May 21, 2012
Primary Completion
July 23, 2013
Study Completion
July 23, 2013
Last Updated
June 10, 2021
Results First Posted
December 25, 2014
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.