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
  Purpose

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 NPS Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: March 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01560403

Locations
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
NPS Pharmaceuticals
Investigators
Study Director: Medical Monitor, NPS NPS Pharmaceuticals
  More Information

No publications provided

Responsible Party: NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01560403     History of Changes
Other Study ID Numbers: TED-C11-001
Study First Received: March 13, 2012
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by NPS Pharmaceuticals:
Short bowel syndrome
Parenteral nutrition
PN
HPN
TPN
SBS

Additional relevant MeSH terms:
Short Bowel Syndrome
Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 19, 2014