A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 (STEPS 3)
This study is enrolling participants by invitation only.
Sponsor:
NPS Pharmaceuticals
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01560403
First received: March 13, 2012
Last updated: April 15, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 18 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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:
- Completion of the 24-month study, CL0600 021, regardless if fully weaned form PN/I.V. support
- 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
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: | April 15, 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 Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Postoperative Complications Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013