A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Short Bowel Syndrome Clinical Trial

— STEPS3  

Official title:

A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560403
• Other study ID #: TED-C11-001
• Status: Completed
• Phase: Phase 3
• Start date: May 21, 2012
• Est. completion date: July 23, 2013

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• Teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 12 months

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & 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. Nut — View Citation

Outcome

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