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

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. Identifier: NCT00930644
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : December 24, 2014
Last Update Posted : December 8, 2015
Nycomed Germany GmbH
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: teduglutide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
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
Study Start Date : September 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Teduglutide

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

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.

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

Inclusion Criteria:

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

Exclusion Criteria:

  • none

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 identifier (NCT number): NCT00930644

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Sponsors and Collaborators
Nycomed Germany GmbH
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Study Director: NPS Clinical Trials NPS Pharma

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shire Identifier: NCT00930644    
Other Study ID Numbers: CL0600-021
First Posted: June 30, 2009    Key Record Dates
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
Additional relevant MeSH terms:
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Short Bowel Syndrome
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Gastrointestinal Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs