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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01560403
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : December 25, 2014
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: Teduglutide Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Teduglutide
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Summary of Treatment-emergent Adverse Events [ Time Frame: 12 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Shire Identifier: NCT01560403     History of Changes
Other Study ID Numbers: TED-C11-001
First Posted: March 22, 2012    Key Record Dates
Results First Posted: December 25, 2014
Last Update Posted: December 8, 2015
Last Verified: December 2014

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