Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Completed · Phase 3

Conditions studied: Short Bowel Syndrome

In brief

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

Key facts

Study ID

NCT00172185

Run by

Shire

People needed

65

Starts

2005-01-10

Expected to finish

2008-01-24

Last updated by the study team

2021-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.
• Subjects who meet all of the following criteria can be enrolled in this study:
• Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
• Completion of protocol CL0600-004 (NCT00081458)

You may not qualify if…

• History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
• History of alcohol or drug abuse (within previous year)
• Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
• Pregnant or lactating women
• Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Albany Medical Center — Albany, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania - Penn Nursing — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Hôpital Erasme — Brussels, Belgium
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Rigshospitalet — Copenhagen, Denmark
• Hôpital Huriez — Lille, France
• Hôpital de la Croix-Rousse — Lyon, France
• Hôpital Lariboisière — Paris, France
• Academic Medical Center, Department of Endocrinology & Metabolism — Amsterdam, Netherlands
• Pracownia Żywienia — Olsztyn, Poland
• Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP — Warsaw, Poland
• St. Mark's Hospital — Harrow, United Kingdom

Full record on ClinicalTrials.gov

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