Short Bowel Syndrome Clinical Trial
— STEPS3Official title:
A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021
Verified date | May 2021 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 23, 2013 |
Est. primary completion date | July 23, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University School of Medicine | Atlanta | Georgia |
United States | Scripps Clinic & Research Foundation | La Jolla | California |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Mount Sinai Medical Center | New York | New York |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Shire |
United States,
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. Nut — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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