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A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 (STEPS3)

This study has been completed.
Information provided by (Responsible Party):
Shire Identifier:
First received: March 13, 2012
Last updated: November 10, 2015
Last verified: December 2014
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.

Condition Intervention Phase
Short Bowel Syndrome
Drug: Teduglutide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Summary of Treatment-emergent Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

Enrollment: 14
Study Start Date: May 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teduglutide
0.05 mg/kg/day
Drug: Teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 12 months
Other Name: Gattex

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01560403

United States, California
Scripps Clinic & Research Foundation
La Jolla, California, United States, 92037
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Study Director: Medical Monitor, NPS NPS Pharma
  More Information

Responsible Party: Shire Identifier: NCT01560403     History of Changes
Other Study ID Numbers: TED-C11-001 
Study First Received: March 13, 2012
Results First Received: December 16, 2014
Last Updated: November 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Short bowel syndrome
Parenteral nutrition

Additional relevant MeSH terms:
Short Bowel Syndrome
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications processed this record on October 25, 2016