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):

March 13, 2012
March 22, 2012
December 16, 2014
December 25, 2014
December 8, 2015
May 2012
August 2013   (Final data collection date for primary outcome measure)
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.
PN/I.V. actual volume (L/week) and change from baseline will be evaluated for each visit during this study. [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01560403 on Archive Site
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A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021
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.
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Short Bowel Syndrome
Drug: Teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 12 months
Other Name: Gattex
Experimental: Teduglutide
0.05 mg/kg/day
Intervention: Drug: Teduglutide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2013
August 2013   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: Medical Monitor, NPS NPS Pharma
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP