A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 (STEPS 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01560403
First received: March 13, 2012
Last updated: October 24, 2013
Last verified: October 2013

March 13, 2012
October 24, 2013
March 2012
August 2013   (final data collection date for primary outcome measure)
PN/I.V. actual volume (L/week) and change from baseline will be evaluated for each visit during this study. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01560403 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
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 form 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01560403
TED-C11-001
Yes
NPS Pharmaceuticals
NPS Pharmaceuticals
Not Provided
Study Director: Medical Monitor, NPS NPS Pharmaceuticals
NPS Pharmaceuticals
October 2013

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