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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930644
First Posted: June 30, 2009
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nycomed Germany GmbH
Information provided by (Responsible Party):
Shire
  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: Intervention Model: Single Group Assignment
Masking: None (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 Shire:

Primary Outcome Measures:
  • Percent Change in PN/IV Volume by Visit [ Time Frame: 24 months ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930644


  Show 23 Study Locations
Sponsors and Collaborators
Shire
Nycomed Germany GmbH
Investigators
Study Director: NPS Clinical Trials NPS Pharma
  More Information

Publications:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00930644     History of Changes
Other Study ID Numbers: CL0600-021
First Submitted: June 26, 2009
First Posted: June 30, 2009
Results First Submitted: December 16, 2014
Results First Posted: December 24, 2014
Last Update Posted: December 8, 2015
Last Verified: January 2015

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

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