Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

Completed · Phase 3 · Has a placebo group

Conditions studied: Short Bowel Syndrome

In brief

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

Key facts

Study ID

NCT00081458

Run by

Shire

People needed

84

Starts

2004-05-25

Expected to finish

2007-07-06

Last updated by the study team

2021-06-09

Who can join

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

You may qualify if…

• Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF)
• SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding
• Body weight must be less than 90 kg
• At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing
• Body mass index (BMI) 18 to 27 kg/m2
• Adequate hepatic and renal function

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)
• Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study
• Clinically significant laboratory abnormalities at the time of randomization
• Previous use of teduglutide (ALX-0600)
• Prior use of native GLP-2 within 3 months of screening visit
• Hospital admission within 1 month prior to 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.
• Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern Center for Clinical Research — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Albany Medical Center — Albany, New York, United States
• Mount Sinai School of Medicine — New York, 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
• Medical University of South Carolina — Charleston, South Carolina, United States
• l'Hôpital Erasme — Brussels, Belgium
• Royal Alexandra Hospital — Edmonton, Alberta, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Rigshospitalet, University of Copenhagen — Copenhagen, Denmark
• Hôpital Claude-Huriez — Lille, France
• Hôpital de la Croix-Rousse — Lyon, France
• Hôpital Edouard Herriot — Lyon, France
• Hôpital Beaujon — Paris, France
• Charité University Hospital — Berlin, Germany

Full record on ClinicalTrials.gov

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