Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

This study has been completed.
Sponsor:
Collaborator:
Nycomed Germany GmbH
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00930644
First received: June 26, 2009
Last updated: August 13, 2013
Last verified: August 2013
  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
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 Long Term, Open Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome Who Completed Study CL0600-020

Resource links provided by NLM:


Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: August 2009
Study Completion Date: January 2013
Primary Completion Date: January 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 24 months
Other Name: Gattex

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
Criteria

Inclusion Criteria:

  • must have completed 24 weeks of dosing of the CL0600-020 study

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: NCT00930644

  Show 24 Study Locations
Sponsors and Collaborators
NPS Pharmaceuticals
Nycomed Germany GmbH
Investigators
Study Director: NPS Clinical Trials NPS Pharmaceuticals
  More Information

No publications provided

Responsible Party: NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00930644     History of Changes
Other Study ID Numbers: CL0600-021
Study First Received: June 26, 2009
Last Updated: August 13, 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 August 28, 2014