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 Pharma
ClinicalTrials.gov Identifier:
NCT00930644
First received: June 26, 2009
Last updated: January 15, 2015
Last verified: January 2015
  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

Resource links provided by NLM:


Further study details as provided by NPS Pharma:

Primary Outcome Measures:
  • Percent Change in PN/IV Volume by Visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.

  • Absolute Change in PN/IV Volume by Visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.


Secondary Outcome Measures:
  • Number of Subjects Achieving PN/IV Reduction [ Time Frame: 24 Months or Last Dosing Visit ] [ Designated as safety issue: No ]
    The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.


Enrollment: 88
Study Start Date: September 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 23 Study Locations
Sponsors and Collaborators
NPS Pharma
Nycomed Germany GmbH
Investigators
Study Director: NPS Clinical Trials NPS Pharma
  More Information

Publications:
Responsible Party: NPS Pharma
ClinicalTrials.gov Identifier: NCT00930644     History of Changes
Other Study ID Numbers: CL0600-021
Study First Received: June 26, 2009
Results First Received: December 16, 2014
Last Updated: January 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by NPS Pharma:
short bowel syndrome
parenteral nutrition
PN
HPN
TPN
SBS

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

ClinicalTrials.gov processed this record on July 30, 2015