Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
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Purpose
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.
| Condition | Intervention | Phase |
|---|---|---|
|
Short Bowel Syndrome |
Biological: 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 Long Term, Open Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome Who Completed Study CL0600-020 |
- further study long-term efficacy and safety in subjects who have completed 24-weeks of dosing in Study CL0600-020 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Long-term safety data and data on PN/IV volume (L/week) will be collected at each study visit. Numbers of subjects who achieve 20, 50, 75 and 100% reduction in PN/IV volume from baseline will be calculated for each visit during this study. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 66 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: teduglutide
0.05 mg/kg/day
|
Biological: teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 24 months
|
Detailed Description:
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- must have completed 24 weeks of dosing of the CL0600-020 study
Exclusion Criteria:
- none
Contacts and Locations
Show 24 Study Locations| Study Director: | Bo Joelsson, MD, PhD | NPS Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Bo Joelsson, MD, PhD. Vice President, Clinical Research, NPS Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00930644 History of Changes |
| Other Study ID Numbers: | CL0600-021 |
| Study First Received: | June 26, 2009 |
| Last Updated: | June 20, 2011 |
| 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 May 21, 2013